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Navigating healthcare compliance requirements? Look no further. This comprehensive resource demystifies the complexities of healthcare compliance, providing practical insights into developing stringent compliance programs and understanding essential certifications and attestations, including HIPAA, SOC 2, and HITRUST.
Whether you’re at a small or medium-sized business, equip yourself with the strategies and tools necessary to uphold the highest standards of data protection and patient care while aligning with the legalities of the healthcare sector.
Healthcare compliance (the ongoing adherence to numerous legal, ethical, and professional standards) is essential to the healthcare industry. It’s no small feat, especially when simultaneously navigating life-and-death outcomes. Compliance in healthcare involves:
Compliance programs, which anchor the integrity of healthcare organizations, ensure that policies and procedures move beyond mere formalities and become integral to corporate compliance. It also upholds and enforces consistent standards across different organizations that collect and interact with protected health information (PHI).
These programs rely on precise reporting mechanisms and corrective actions to maintain adherence to the myriad of laws and regulations.
In our digitized era, where data is highly valued, the Health Insurance Portability and Accountability Act (HIPAA) helps to protect patient information. This foundational regulation demands rigorous standards for the security and confidentiality of sensitive data, a bulwark against the ever-looming threats of breaches and unauthorized access.
The sanctity of individual health information is not a suggestion; it is a mandate, with healthcare providers as the custodians of this sacred trust.
You may think healthcare compliance is the concern of traditional healthcare providers like hospitals, clinics, and private practices. This is true, but it’s not limited to these critical services: For example, pharmaceutical companies, insurance providers, medical device manufacturers, and even entities involved in healthcare billing and coding must all adhere to stringent compliance standards to ensure the protection of patient information and the delivery of high-quality care.
Expanding to more established sectors, healthcare compliance is a critical concern for a broader spectrum of businesses and services within the healthcare industry.
The term ‘healthcare technology companies,’ or HealthTech, has become increasingly prevalent. This innovative and dynamic sector includes diverse services and products that leverage technology to enhance healthcare delivery and improve patient outcomes. Commitment to healthcare compliance is paramount for these burgeoning enterprises, ensuring they meet the highest standards of care and data protection.
The HealthTech landscape can be categorized into four main areas:
Telehealth services have soared in popularity, especially in the wake of global health challenges that necessitated remote care. This category includes telemedicine solutions offering specialty fulfillment, home testing, home health solutions, and online primary and general care services. As these services provide direct patient care, they must comply with stringent regulations to ensure patient privacy, data security, and accurate billing practices.
The field of digital therapeutics and treatments blends technology with medical care. It features innovative approaches such as digital prescription services, virtual reality (VR) treatments and therapies, neurological and brain health solutions, and tools for managing chronic conditions. Companies operating in this space are responsible for adhering to compliance standards that govern medical devices, patient safety, and evidence-based outcomes.
Health coaching and wellness platforms are designed to support individuals in managing their health and well-being. These platforms offer services related to alcohol and substance abuse treatment, nutrition and weight loss programs and apps, heart health and cardiac rehabilitation, as well as pain management and physical therapy (PT).
While they may not always provide direct medical treatment, these services are still subject to compliance regulations that protect user data and ensure the delivery of health information in a responsible manner.
Digital care management encompasses a wide array of technological solutions aimed at streamlining the healthcare experience for both providers and patients. This includes AI-driven care management technologies, care search tools, and platforms that assist individuals in navigating health benefits.
These tools are critical in managing patient care and must comply with healthcare regulations to ensure that they provide accurate, accessible, and secure information and services.
If your business operates in any of these categories, healthcare compliance should be an ongoing concern. It requires continuous monitoring, regular updates to policies and procedures, and adherence to a complex web of regulations that include, but are not limited to, HIPAA, the Federal Anti-Kickback Statute, and various state and federal laws. Let’s look more closely at what’s involved in healthcare compliance.
Developing an effective compliance program involves a systematic approach, incorporating the seven core elements recommended by the Department of Health and Human Services.
Those core elements are:
The compliance officer, often known as an HCO or Healthcare Compliance Officer, plays an essential role in healthcare organizations. Certifications such as Certified in Healthcare Compliance (CHC) or Certified Compliance and Ethics Professional (CCEP) are highly regarded in the healthcare compliance community. Along with these, a wealth of experience and a keen eye on the ever-changing regulatory landscape, these professionals are entrusted with:
Key certifications serve as markers on the path to healthcare excellence, symbolizing an organization’s steadfast commitment to patient data protection and strict adherence to regulatory norms. For HealthTech organizations, HIPAA, SOC 2, and HITRUST certifications are essential. Let’s look at each in more detail.
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HIPAA compliance symbolizes an organization’s unwavering commitment to the protection and confidentiality of Protected Health Information (PHI).
While the Department of Health and Human Services (HHS) does not officially endorse compliance with HIPAA, third-party audits can provide proof of HIPAA compliance, indicating to patients and partners that a healthcare entity is resolute in upholding the highest standards of privacy and security.
This regulatory standard involves a rigorous evaluation process where an organization’s policies, procedures, and operations are assessed to ensure compliance with the HIPAA Privacy Rule, which governs the use and disclosure of PHI, and the HIPAA Security Rule, which sets standards for the safeguarding of electronic PHI (ePHI).
By achieving HIPAA compliance, organizations demonstrate their dedication to safeguarding patient data and adherence to complex regulatory requirements critical to their operation within the healthcare sector.
Learn more about HIPAA compliance.
SOC 2 attestation represents more than a mere accolade; it is a testament to an organization’s commitment to protecting personal health information.
Anchored in the Trust Services Criteria, which encompass security, availability, processing integrity, confidentiality, and privacy, and informed by the principles of the COSO framework, SOC 2 attestation is a comprehensive and detailed process. It involves an in-depth audit that evaluates and verifies the effectiveness of a company’s controls and processes related to data security and privacy.
By achieving SOC 2 attestation, a healthcare entity publicly affirms its dedication to maintaining security measures and handling private information with the utmost care, thereby demonstrating its trustworthiness.
Learn more about the SOC 2 audit process.
HITRUST certification is the gold standard in healthcare data security, representing a comprehensive framework that consolidates various security regulations into a single, streamlined strategy.
Achieving this certification signifies a company’s strategic commitment to data security and compliance and its capability to navigate the intricate landscape of healthcare regulations precisely. The HITRUST CSF (Common Security Framework) is a certifiable framework that provides organizations with a comprehensive, flexible, and efficient approach to regulatory compliance and risk management.
Developed in collaboration with healthcare and IT professionals, the CSF incorporates nationally and internationally accepted standards, including ISO, NIST, PCI, and HIPAA, to ensure a comprehensive set of baseline security controls. The certification process involves a rigorous assessment that evaluates an organization’s information protection systems and processes against the CSF’s benchmarks.
Organizations that earn the HITRUST CSF Certification have demonstrated due diligence in protecting sensitive information and managing information risk across third-party vendors. They are recognized for having a robust approach to data protection that meets key regulatory and industry-defined requirements.
Learn more about HITRUST e1, i1, and r2 certification.
Fostering a compliance culture in a healthcare organization requires dedication, patience, and ethical stewardship. When compliance is embedded in an organization’s DNA, legal and financial risks are mitigated, and a balance between regulations and patient care is achieved, safeguarding the organization’s integrity and reputation.
To weave compliance into the very fabric of an organization, leaders must embody the values they seek to instill. Clear communication and staff involvement in policy development fosters a collaborative atmosphere where compliance is not just a mandate but a shared vision.
With the aid of technology, organizations can solidify this ethos, ensuring compliance is not just another checkmark on a to-do list but a daily occupation.
Various teaching methods, from online modules to simulation-based training, will help equip your staff with the knowledge and skills to maintain the highest compliance standards, ensuring that the organization’s practices always align with the latest regulations.
Those who ignore the legal requirements of healthcare compliance face considerable risk. The consequences of non-compliance range from hefty fines to exclusion from federal programs and even criminal charges.
The Federal Anti-Kickback Statute (AKS) is a critical law in healthcare that prevents financial incentives from influencing medical decisions. Violating AKS can lead to severe consequences, including jail time, emphasizing the importance of ethical conduct in healthcare.
Adhering to the AKS ensures that patient care and federal healthcare programs are protected from fraud and abuse.
The Office of Inspector General (OIG) is responsible for:
From advanced software solutions that streamline compliance processes to professional support services that provide specialized expertise, resources, and tools are available to help healthcare organizations maintain compliance, keeping their operations aligned with the ever-changing regulatory landscape.
Compliance software solutions enhance efficiency and provide the clarity and precision needed to navigate the complexities of regulations and ensure that a healthcare organization’s compliance is beyond reproach. Some key features of compliance software solutions include:
Healthcare organizations can streamline their compliance processes and stay on top of regulatory requirements by utilizing these features.
Even with the most advanced software, the human element remains integral to healthcare compliance. Professional support services provide specialized expertise that can bridge gaps, enhance understanding, and offer guidance to avoid compliance pitfalls.
Achieving healthcare compliance is not a one-time event but a continuous journey demanding vigilance, adaptability, and a proactive approach.
As regulations evolve and new challenges emerge, healthcare organizations must continually refine their compliance strategies, ensuring their practices remain in lockstep with the latest standards and expectations.
Regular audits and risk assessments form the backbone of a sturdy compliance program. Organizations can identify vulnerabilities through these processes before they fester into full-blown compliance breaches.
Compliance officers must have their fingers on the pulse of developments, from the intricacies of telemedicine services to the nuances of value-based physician compensation.
As the healthcare landscape evolves, so must the strategies and systems used to manage compliance, ensuring that patient care, data security, and the organization’s reputation remain intact amid the ebb and flow of industry evolution.
The larger you become and the more data you take on, the greater the impact an unexpected disaster can have. That is why it is wise to develop an effective healthcare compliance program quickly rather than deal with the consequences later when you have a world-ending amount of data.
Creating a customized program for healthcare-covered entities and business associates will naturally revolve around complying with HIPAA, SOC 2, HITRUST, or a combination of the three. Implementing policies and procedures that enhance the ongoing security of PHI in response to constantly changing healthcare regulations is critical. Building an ever-evolving compliance roadmap that involves all employees across organizational functions is key.
Note: This blog post was originally posted on June 12, 2023, and was reviewed by internal SMEs and updated on April 18, 2024.
The Certified in Healthcare Compliance (CHC)® credential signifies expertise in compliance processes and knowledge of relevant regulations, enabling individuals to assist healthcare organizations in meeting legal requirements and maintaining organizational integrity.
The five key areas of compliance are leadership, risk assessment, standards, and controls, training and communication, and oversight. These elements form a crucial framework for a compliance program.
The primary purpose of healthcare compliance is to ensure that healthcare organizations adhere to legal, ethical, and professional standards, thus protecting patient privacy, ensuring employee safety, maintaining industry integrity, and preventing fraud, waste, and abuse.
Compliance programs are essential for healthcare organizations because they provide structure and guidance for ethical behavior, help prevent fraudulent activities, and contribute to creating an ethical culture to safeguard patient welfare.
Healthcare organizations should consider certifications such as HIPAA, SOC 2, and HITRUST to showcase their dedication to data protection and regulatory compliance. These certifications affirm their commitment to safeguarding sensitive information.
HITRUST Guide
The future of health tech is HITRUST! Get ahead of the curve and understand the how and why of HITRUST in this in-depth guide.
As we enter 2024, Healthcare Technology (HealthTech) Infosec Teams will be asked to do more with less. Cyber threats for HealthTech continue to grow at a rapid pace. As the iconic Pat Benatar says, “Love is a Battlefield“—and so is healthcare compliance.
Thoropass infosec compliance experts Leith Khanafseh and Zach Rutz recently met with Ryan Patrick, VP of Adoption at HITRUST, for an intriguing webinar titled: Future Trends in Healthcare Compliance: How to use HITRUST as the foundation to a multi-framework approach.
This article highlights some of the key takeaways, including:
Miss the webinar? You can watch the whole discussion here.
The healthcare sector, ripe with extensive sensitive data, has quickly become the #1 attacked industry. A recent report by Claroty found that 78% of surveyed healthcare organizations experienced a cybersecurity incident in the last year, and 55% of those breaches resulted from a third-party breach, such as the Okta security breach, resulting in a butterfly effect.
The complete nature of healthcare records makes it a prime target. The situation is exacerbated by the sector’s dependence on outdated regulations established in an era before wireless, big data, and cloud technologies. As a result, healthcare providers must remain vigilant and prioritize cybersecurity measures to protect patient information.
Adherence to comprehensive information security standards and regulations like HIPAA, HITRUST, and SOC 2 is now a must-have. Compliance officers play a crucial role in ensuring adherence to laws, requirements, and ethical standards, emphasizing the prevention, detection, and resolution of non-compliant conduct through an effective compliance program. However, the industry is currently grappling with significant obstacles in cybersecurity and risk management due to subpar compliance programs, outdated regulations, and the high value of its data.
The Health Insurance Portability and Accountability Act (HIPAA) was established as a fundamental framework for healthcare compliance and healthcare security. However, in the face of evolving threats and the rapid advancement of technology, compliance with HIPAA alone is no longer sufficient.
As stated by Ryan Patrick of HITRUST, the healthcare sector must exceed HIPAA requirements to guarantee enhanced protection. While progress has been made in healthcare sector security, it is slow and not keeping pace with the increasing threats. Even though HIPAA revisions may be underway, they haven’t been implemented yet, leaving numerous healthcare entities in a risky situation.
Meanwhile, novel solutions are emerging in response to contemporary, more adaptable threats. The healthcare sector coordinating council is working with various initiatives to enhance the security of the healthcare industry, including collaboration with human services organizations. However, HIPAA’s limitations in addressing current security threats necessitate a more robust solution.
Compliance requirements for healthcare entities are escalating, with the average organization now obliged to adhere to three or four frameworks. The intricate task of aligning with multiple compliance frameworks, each with its distinct requirements, can result in a heightened administrative burden and escalated expenses and resources required to prove compliance across various standards. Implementing effective compliance programs can help organizations manage these challenges more efficiently by utilizing appropriate compliance resources.
Introducing the HITRUST Common Security Framework (HITRUST CSF), a holistic framework for centralizing information security initiatives. This framework can eliminate the insanity of providing evidence for the same control repeatedly across different frameworks, a situation many healthcare organizations find themselves in.
Utilizing HITRUST in conjunction with other necessary frameworks, like SOC 2, allows healthcare entities to:
This approach results in a more efficient and effective approach to information security and compliance, which is the core of an effective compliance program.
Established over 16 years ago to solve for the fact that HIPAA can be quite vague and subjective, HITRUST offers a predefined set of security and privacy controls. The HITRUST report is a comprehensive framework of security and privacy controls, aligned with 40 other authoritative sources, designed to ensure robust data protection within the healthcare industry.
HITRUST’s assurance program provides a high degree of certainty through a methodology that emphasizes verification alongside trust. Organizations pursuing HITRUST certification undergo an impartial assessment by a validated HITRUST External Assessor like Thoropass to validate their compliance milestones, leading to certification. The HITRUST framework, therefore, provides the much-needed assurance of data protection and compliance in an industry where data breaches are on the rise.
HITRUST fully or partially covers a wide array of standards and frameworks, including applicable trust service criteria, such as:
HITRUST is not just working in isolation; it is actively collaborating with other standards bodies and industry stakeholders. For instance, HITRUST is working with the stateRAMP team to build a program where HITRUST certification can expedite the stateRAMP authorization process. It is also recognized by Texas’s own cloud service provider authorization program, txRAMP, as a viable option to fast-track their authorization process. This level of collaboration makes HITRUST a valuable asset not just for healthcare organizations, but for a broad range of entities dealing with sensitive data.
By collaborating with various industry stakeholders, HITRUST aids constituents in navigating their processes and building trust more efficiently. Additionally, the federal government acknowledges the worth of HITRUST certification. It now requires qualified health information networks to get HITRUST certified, proving the worth of HITRUST certification in the broader regulatory landscape.
Moreover, clients are capitalizing on their HITRUST certifications during the cyber insurance underwriting process, thus receiving more advantageous terms.
Although HITRUST, SOC 2, and HIPAA may appear to be distinct entities, they share common objectives—safeguarding the security and privacy of sensitive data. HITRUST can cover a majority of SOC 2 and HIPAA regulations if the controls are properly mapped. This makes HITRUST a comprehensive solution for healthcare organizations grappling with multiple compliance requirements.
HITRUST? SOC 2? Both? Discover the right mix for your business
While it may be necessary for healthcare organizations to pursue SOC 2 and HIPAA alongside HITRUST, the comprehensive nature of the HITRUST framework can simplify this process significantly. Despite being industry-agnostic, HITRUST still has a HIPAA core, which makes it particularly beneficial for healthcare organizations.
HITRUST’s e1 offers good cyber basics, i1 covers the majority of the HIPAA security rule, and r2 offers the option to cover it completely. With this level of coverage, it’s clear that HITRUST, SOC 2, and HIPAA are not mutually exclusive but can work together to provide a comprehensive compliance solution for healthcare organizations.
In the journey to handle multiple frameworks, automation and effective solutions can play a significant role. Thoropass helps customers leverage automation to pursue a multiple framework approach and simplify and streamline the process.
With Thoropass, you can:
Automation can also play a significant part in making compliance efforts more efficient by minimizing duplicate work, leading to increased productivity and less resource usage. With automation, healthcare organizations can focus on their core business functions while ensuring that they remain compliant with multiple regulatory frameworks.
Prior to the introduction of an automated solution like Thoropass, organizations frequently implemented SOC 2, HITRUST, and HIPAA separately. This process, involving engineers, product managers, and CISOs, could span the course of an entire year, with each standard taking several months to implement.
Nonetheless, the emergence of automation technologies combined with the development HITRUST over the last decade has changed the game for HealthTech companies looking to future proof their business. By leveraging integrations and efficiencies across all frameworks, HealthTech organizations can make the process more manageable, reducing the time and resources required to prove compliance with the help of HITRUST certification reports.
The advantages of this approach are evident:
One organization that has successfully navigated the complex landscape of healthcare compliance is Analog Informatics. Analog Informatics offers solutions for patient engagement, reputation management, and anomaly detection with AI, aimed to demonstrate their commitment to security to their customers and potential customers.
Analog Informatics opted to consolidate its HIPAA, HITRUST, and SOC 2 certification efforts into a single initiative, capitalizing on existing compliance measures to showcase its commitment to security. This approach enabled Analog Informatics to manage its compliance requirements efficiently, demonstrating the viability of a multi-framework approach with the support of automation and by placing HITRUST as the cornerstone of their compliance program.
Our experts offer some final advice as your forge ahead on your quest to innovate in the healthcare space.
Zach: Expand further into the supply chain to see what other players could pose a risk to the overall security of your systems. Given that 55% of breaches are caused by third party companies, you must broaden your coverage beyond your primary partners.
Leith: Start early, especially if you’re in the healthcare space. It’s never too early to start. HITRUST even introduced a basic e1 certification to help smaller companies get a foot in the door”
Ryan: Think about your cybersecurity from a threat informed perspective. Putting threat at the centre is really, really critical. HITRUST provides security over compliance when it comes to these different assurance mechanisms. It’s not a time to ignore what’s going on from a threat perspective.
One audit, multiple frameworks
Thoropass’s AI-infused technology and expert guidance allow you to achieve more with less. With Unified Controls and multi-framework action items, you’ll save time and resources and acheive yoru compliance goals faster than ever before.
Oro provides content designed to educate and help audiences on their compliance journey.
Imagine being hit with hefty fines, a damaged reputation, and potential criminal charges, all because of a missing piece in your organization’s security strategy. In the world of healthcare, encryption is a vital piece that can make all the difference in protecting sensitive patient data and avoiding the harsh consequences of noncompliance with the Health Insurance Portability and Accountability Act (HIPAA). So, are you equipped with the knowledge to ensure your organization is compliant?
Navigating the complex world of HIPAA encryption requirements can be daunting, but fear not! We’re here to help you understand the ins and outs of encryption, its role in HIPAA compliance, and how to select the right software and services to keep protected health information (PHI) safe and secure.
At its core, HIPAA is a set of rules designed to protect patient health information and ensure medical services are efficient and free from fraud. One of the key components of HIPAA is the Security Rule, which focuses on safeguarding PHI through various technical, physical, and administrative measures. Encryption is a crucial aspect of the Security Rule, serving as a powerful tool to protect PHI from unauthorized access and potential data breaches.
However, encryption in HIPAA is not a one-size-fits-all solution. The addressable implementation specifications in the Security Rule allow for flexibility in encryption methods, depending on an organization’s unique needs and risks. By understanding the various encryption standards and requirements, healthcare organizations can make informed decisions on the best way to protect their patients’ data and maintain HIPAA compliance.
The Security Rule establishes encryption as a method to prevent unauthorized access to PHI. Specifically, the Rule’s implementation specifications for data encryption requirements are outlined in 45 CFR 164.312(a)(1)(iv) and 45 CFR 164.312(e)(2)(ii) of the Technical Safeguards.
By encrypting data, organizations can significantly reduce the chances of unauthorized individuals accessing and tampering with sensitive information, thus minimizing the risk of triggering the breach notification rule.
Data classification is another important aspect of the Security Rule, as it helps organizations identify the appropriate security measures needed to protect various types of sensitive information. By following the encryption requirements outlined in the Security Rule and classifying data accordingly, healthcare organizations can ensure they are taking the necessary steps to protect their patients’ PHI and maintain compliance with HIPAA regulations.
While encryption is an addressable security measure in HIPAA, it doesn’t mean that covered entities can simply ignore encryption altogether.
Instead, if an organization chooses not to follow the HIPAA encryption requirements, it must implement an alternative security measure that provides equal or greater protection for PHI. This flexibility in encryption methods is a result of the Security Rule’s technology-neutral approach, requiring implementations that are deemed “reasonable and appropriate”.
Risk assessment and risk analysis play a pivotal role in determining the most suitable encryption solutions for an organization. By evaluating potential risks and vulnerabilities, healthcare organizations can make informed decisions on the best encryption methods to protect their PHI, whether it be through the use of encryption software or alternative security measures.
Encryption is just one element of the Security Rule. Get the full breakdown of what compliance looks like.
HIPAA data encryption requirements apply to both data at rest (stored on servers, devices, etc.) and data in transit (during transmission). Ensuring that electronic and other protected health information (PHI) is encrypted–in both scenarios–is critical to protecting sensitive patient information from unauthorized access, regardless of whether the data is stolen from a server or intercepted during transmission over an open network.
To help organizations achieve this level of protection, HIPAA recommends specific HIPAA encryption standards for both data at rest and data in transit, as well as guidelines on selecting the appropriate encryption software and services to meet these requirements since HIPAA requires encryption.
By adhering to these guidelines, healthcare organizations can significantly reduce the risk of data breaches and maintain compliance with HIPAA regulations.
Data at rest refers to any inactive data stored on a digital medium, such as server hard drives, solid-state drives (SSD), or mobile devices like tablets and phones. Encrypting data at rest is essential in preventing unauthorized access to PHI stored on these devices and systems. To achieve this level of protection, HIPAA-compliant protocols for data at rest encryption should align with NIST Special Publication 800-111, “Guide to Storage Encryption Technologies for End User Devices.”
Examples of data at rest encryption solutions include Window’s BitLocker and Mac’s FileVault, which encrypts all data on a hard drive (also known as full disk encryption (FDE)) and other file-based encryption (such as WinZip Enterprise), which encrypts data at the file level to keep it secure from unauthorized users. By implementing these encryption solutions, healthcare organizations can effectively protect PHI stored on various devices and maintain HIPAA compliance.
Data in transit involves the transmission of PHI between devices or systems, such as when patient information is shared between healthcare providers via email or uploaded to the Cloud. Encrypting data in transit is crucial in ensuring the security of PHI during transmission, preventing any interception or unauthorized access to sensitive information. HIPAA suggests taking necessary steps to ensure the secure transfer of data. As per NIST Special Publication 800-52 “Guidelines for the Selection and Use of Transport Layer Security (TLS) Implementations,” and 800-77 “Guide to IPsec VPNs,” are recommended for secure data transfer.
Transport Layer Security (TLS) is a protocol that provides an extra layer of security to data transmissions over the web. It is commonly used with HTTPS, email, and instant messaging. By implementing TLS and other recommended encryption methods, healthcare organizations can effectively safeguard PHI during transmission, reducing the risk of data breaches and maintaining HIPAA compliance.
Choosing the right encryption software and services is crucial for ensuring HIPAA compliance and protecting your organization’s sensitive patient data. With a myriad of encryption solutions available on the market, it is essential to consider the recommended encryption standards and evaluate email service providers for HIPAA compliance.
By selecting encryption software and services that align with HIPAA requirements, healthcare organizations can ensure PHI is properly protected and reduce the risk of fines, penalties, and reputation damage that can result from non-compliance. Additionally, investing in the right encryption solutions demonstrates an organization’s commitment to safeguarding patient data and maintaining compliance with HIPAA regulations.
The Department of Health and Human Services (HHS) recommends rendering PHI “unusable, unreadable, or indecipherable to unauthorized individuals”. This can be accomplished by using “an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key.” The following encryption standards have been judged to meet these requirements:
Note: AES is a symmetric block cipher that uses a single key to encrypt and decrypt data in blocks, offering a high level of security for protecting sensitive information.
While HHS does not endorse specific encryption software, organizations must ensure their chosen solution meets these recommended standards. By adhering to the encryption guidelines put forth by HHS and NIST, organizations can effectively protect PHI and maintain compliance with industry regulations.
Email services play a significant role in the transmission of PHI between healthcare providers and other entities. To ensure HIPAA compliance, email services must support audit, integrity, and authentication controls. They also must enter into a Business Associate Agreement with the covered entity. Office 365 is an example of a HIPAA-compliant email service. It offers both encryption and a signed Business Associate Agreement with Microsoft.
When evaluating email services for HIPAA compliance, it is essential to consider the security measures in place for data at rest and in transit, the encryption standards used, and the capability to audit and track access to the data. By selecting an email service provider that meets these criteria, healthcare organizations can ensure the secure transmission of PHI and uphold their commitment to HIPAA compliance.
A comprehensive security strategy is key to protecting PHI and maintaining HIPAA compliance. An effective strategy combines technical, physical, and administrative safeguards to create a robust defense against threats. In addition, regular risk assessments and analyses are crucial in identifying vulnerabilities and implementing appropriate security measures to address them.
By developing and implementing a well-rounded security strategy, healthcare organizations can not only meet HIPAA encryption requirements but also proactively protect their patients’ sensitive data from potential breaches and unauthorized access.
This comprehensive approach to security ensures that organizations are better equipped to handle the ever-evolving landscape of cybersecurity threats and maintain compliance with industry regulations.
Implementing a combination of technical, physical, and administrative safeguards is essential in protecting PHI and ensuring HIPAA compliance. Technical safeguards include measures such as access control, audit controls, integrity, person or entity authentication, and transmission security, all of which help prevent unauthorized access to PHI. Physical safeguards involve protecting data from physical damage or destruction, while administrative safeguards focus on protecting data through administrative processes.
By incorporating a variety of encryption and security measures into their overall security strategy, healthcare organizations can create a robust defense against potential threats to PHI. This comprehensive approach to security not only helps maintain HIPAA compliance but also demonstrates an organization’s commitment to safeguarding patient data and protecting their privacy.
Regular risk assessments play a vital role in identifying potential vulnerabilities within an organization’s security strategy. These assessments involve recognizing possible risks, evaluating the likelihood and impact of those risks, and implementing measures to mitigate or eliminate them. By conducting regular risk assessments, healthcare organizations can proactively address potential threats and ensure appropriate security measures are in place to protect sensitive patient data.
The benefits of conducting risk assessments include an improved compliance record, a lower risk of data breaches, and a better security posture for the organization. By identifying and addressing potential vulnerabilities, healthcare organizations can maintain HIPAA compliance and demonstrate their commitment to protecting patient privacy.
Non-compliance with HIPAA encryption requirements can have significant consequences for healthcare organizations, including fines, penalties, and damage to their reputation. In some cases, non-compliance can even lead to criminal charges and jail time.
On the other hand, compliance with encryption requirements offers numerous benefits, such as an improved compliance history and a reduced risk of notifiable data breaches. By adhering to HIPAA encryption requirements and implementing a comprehensive security strategy, healthcare organizations can not only avoid the negative consequences of non-compliance but also demonstrate their commitment to protecting patient privacy and ensuring the security of sensitive data.
Non-compliance with HIPAA encryption requirements can result in significant financial and reputational consequences for healthcare organizations. Fines for non-compliance can range from $100 to $50,000 per violation, with a maximum penalty of $1.5 million per year for violations of an identical provision.
In addition to the financial impact, almost half of organizations have experienced a hit to their reputation after a data breach, with nearly 90% of consumers stating they would switch to a different company if it had a data breach.
One notable example of encryption-related non-compliance is the case of Lifespan Health System Affiliated Covered Entity (Lifespan ACE), which faced a $1 million penalty after a data breach due to its failure to encrypt mobile devices, as recommended by a risk assessment.
By complying with HIPAA encryption requirements, healthcare organizations can avoid such penalties and safeguard their reputation in the industry.
Compliance with encryption requirements not only helps protect PHI but also contributes to an organization’s improved compliance history with the Department of Health and Human Services (HHS). By demonstrating a commitment to following HIPAA regulations and proactively protecting patient data, healthcare organizations can reduce the likelihood of notifiable breaches and maintain a better compliance record.
Additionally, incorporating encryption requirements from the HIPAA Security Rule as part of a recognized security framework can be viewed favorably by HHS, potentially reducing the likelihood of compliance investigations and enforcement actions.
Understanding and implementing HIPAA encryption requirements is crucial for healthcare organizations to protect patient privacy and ensure compliance with industry regulations.
By incorporating a comprehensive security strategy, including technical, physical, and administrative safeguards, organizations can effectively safeguard PHI and reduce the risk of data breaches. Regular risk assessments and analysis play a vital role in identifying potential vulnerabilities, allowing healthcare organizations to proactively address threats and maintain a strong compliance record.
Navigating the complex world of HIPAA encryption may seem daunting, but with the right knowledge and resources, organizations can effectively protect their patients’ sensitive data and avoid the costly consequences of non-compliance. By investing in the right encryption software and services, healthcare organizations demonstrate their commitment to patient privacy and ensure the security of PHI, both at rest and in transit.
Yes, HIPAA requires encryption of protected health information and electronic PHI when the data is at rest. Exceptions may apply.
Yes, HIPAA requires encryption of protected health information (PHI) and electronic PHI (ePHI), though there are certain exceptions. The National Institute of Standards and Technology (NIST) recommends protecting PHI data with FIPS 140 approved encryption.
Electronic PHI must be encrypted if no other alternative measure is implemented or if there is a justifiable reason for not implementing encryption.
HIPAA requires ePHI to be encrypted during transmission, which could include email; however, a patient may request their email be sent via email. If the patient submits the appropriate consent form to receive the email and the patient understands (and accepts) the risks of sending their protected health information through email (in an unencrypted fashion), then the email may be sent without encryption. HHS still highly recommends the use of encryption for email or to provide an alternative secure solution for a patient to obtain their PHI (such as a secure portal).
HIPAA encryption requirements help protect sensitive patient information from being viewed by unauthorized parties and can help ensure the integrity of medical services.
Failing to comply with HIPAA encryption requirements can have serious consequences, including hefty fines, jail time, and damage to reputation.
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A recent report by Claroty found that 78% of surveyed healthcare organizations experienced a cybersecurity incident in the last year.
This is not only a concern for the organizations themselves but also for patients whose personal information may be compromised. Furthermore, over 60% of respondents reported a moderate or substantial impact on care delivery due to a cybersecurity incident. In this blog, we will explore why the healthcare industry is more vulnerable than others in today’s environment and what organizations can do to mitigate these risks.
The healthcare industry is a prime target for cyber-attacks because of the sensitive information they store and transmit. Medical records, insurance information, and financial data are all valuable to cyber-criminals.
Besides the value of the data, the healthcare industry is vulnerable because of outdated systems, limited budgets, and a lack of expertise. Many healthcare organizations still need to use legacy systems that are compatible with modern security measures.
In addition, budget constraints often leave security measures as an afterthought rather than a priority. Healthcare systems IT budgets typically make up around 6% or less of total budget, indicating cybersecurity’s prioritization (or lack thereof).
Beyond that, healthcare systems must do their due diligence on any third parties and supply chain partners they work with. A 2021 Bluevoyant study reported that 93% of enterprise companies suffered a breach due to a supply chain or third-party vendor—with Healthcare reported to experience the largest proportion of third-party beaches.
This begs the question: What can healthcare and their HealthTech vendors do to mitigate the occurrence and impact of these data breaches?
Data breaches can have significant financial and reputational consequences for healthcare organizations. Data breaches can result in penalties and fines from regulatory bodies, and patients will likely lose confidence in an organization that a cybersecurity incident has impacted.
A data breach can also impact service delivery, depending on how long it takes to contain the breach, resulting in loss of revenue and increased spending on mitigation and recovery efforts.
Let’s look at a couple of examples to get a sense of the potential scale of third-party data breaches in the healthcare industry.
Mom’s Meals is a meal delivery service for people with chronic health conditions. In April 2023, it announced a data breach affecting more than 1.2 million customers. Data, including personal and protected health information (PHI), was made vulnerable in an attached late Jan / early Feb 2023.
The data breach also impacted the company’s current and former employees as well as independent contractors.
Eyecare Leaders (ELC) is an ophthalmology-specific EMR software. In 2022, a ransomware attacker obtained access to its database containing data such as patient names, phone numbers, addresses, emails, gender, birth dates, driver’s license numbers, health insurance information, appointment information, medical record numbers, Social Security numbers, and medical information relating to ophthalmology services.
The ELC breach affects countless healthcare organizations, affecting over 2 million patients.
Healthcare and HealthTech organizations must adopt a proactive approach to cybersecurity. Investing in modern security measures, such as firewalls, intrusion detection, and data encryption, is a priority.
Regular security audits and vulnerability assessments should be conducted to identify gaps in the security system. Regarding cybersecurity, respondents of the Claroty poll reported NIST and HITRUST as the most important security standards in a global crisis.
Spoiler alert: If your organization can’t dedicate an internal resource to ongoing monitoring and maintenance, solutions like Thoropass can help!
HealthTech organizations can also provide regular cybersecurity training to staff, emphasizing the importance of adhering to security protocols and identifying potential phishing attacks.
Data breaches in the healthcare industry are a growing concern. The loss of valuable data, financial impact, and reputational damage that result from cybersecurity incidents can impact the delivery of healthcare services, leaving patients vulnerable.
Healthcare and HealthTech organizations must invest in modern security measures, including dedicating resources to ensure ongoing monitoring and maintenance. While having plans in place should something go wrong, proactivity is the name of the game. The best approach for preparing for a data breach is to prevent it from happening in the first place. The bad actors will only get smarter and more aggressive, so it’s essential to be prepared.
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This post was written with help from AI, but all original thoughts and advice are those of the author. This post has also been peer-reviewed by in-house experts with the knowledge skills, and expertise to corroborate its accuracy.
It can be daunting to navigate the complex world of healthcare regulations, but understanding the Health Insurance Portability and Accountability Act (HIPAA) Security Rule is a crucial piece of the puzzle.
Ensuring the confidentiality, integrity, and availability of protected health information (PHI) is not only a legal obligation but also essential for maintaining trust in the healthcare system. With the ever-evolving landscape of technology and cybersecurity threats, understanding the HIPAA Security Rule is more important than ever.
Let’s dive in and explore the intricacies of this vital regulation.
The HIPAA Security Rule is designed to protect sensitive health information. At the same time, the rule allows healthcare organizations to use new technology to enhance patient care and operational efficiencies.
The Security Rule focuses on securing protected health information (PHI) and ensuring its confidentiality, integrity, and availability. Compliance with this rule is mandatory for HIPAA-covered entities, business associates, and certain federal agencies, with resources such as Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide, guiding you on meeting the requirements set by the Department of Health and Human Services (HHS).
But what does it mean to protect PHI in terms of confidentiality, integrity, and availability? Why is flexibility and scalability so important in the healthcare industry? Let’s dive deeper into these concepts and understand how they shape the HIPAA Security Rule.
The three major components of the HIPAA Security Rule are:
Administrative safeguards play a significant role in achieving these three components, referring to the administrative actions, policies, and procedures that manage the selection, development, implementation, and maintenance of security measures. By diligently implementing and maintaining these safeguards, covered entities and business associates can ensure the proper protection and authorized access to PHI.
The HIPAA Security Rule is designed to be flexible, allowing covered entities and business associates to tailor their policies, procedures, and technology to their size, structure, and risks to consumers’ PHI.
This flexibility is particularly important in the ever-evolving healthcare industry, where new technologies and threats emerge constantly. Physical safeguards, for example, include measures that protect electronic information systems and related buildings and equipment from natural and environmental hazards, as well as unauthorized intrusion.
To accommodate varying needs, the Security Rule includes required and addressable implementation specifications.
Implementation specifications identified as required must be fully implemented by the covered organization. Furthermore, all HIPAA Security Rule requirements identified as Standards are classified as required.
The concept of an addressable implementation specification was developed to provide covered organizations flexibility with respect to how the requirement could be satisfied. To meet the requirements of an addressable specification, a covered organization must:
Where the organization chooses an alternative control or determines that a reasonable and appropriate alternative is not available, the organization must fully document its decision and reasoning. The written documentation should include the factors considered as well as the results of the risk assessment on which the decision was based.
Covered entities and business associates play significant roles in the protection of PHI under the HIPAA Security Rule. Both groups must ensure the confidentiality, integrity, and availability of PHI and comply with implementation of the rule.
“A “business associate” is a person or entity that performs certain functions or activities that involve the use or disclosure of protected health information on behalf of, or provides services to, a covered entity.” – Office for Civil Rights (OCR)
Covered entities include:
Roles and responsibilities within these groups vary, with health plans, clearinghouses, and providers having unique obligations and vendor responsibilities that must be addressed. Let’s dive deeper into the specifics of each group’s role in the HIPAA Security Rule.
Health plans are organizations that provide or arrange healthcare services, such as health insurance companies, HMOs, and government programs.
Healthcare clearinghouses process nonstandard health information into a standard format or vice versa, while healthcare providers are individuals or organizations that furnish, bill, or are paid for healthcare. As covered entities under the HIPAA Security Rule, these groups must comply with the rule’s requirements to protect PHI.
Healthcare providers such as doctors, in particular, are responsible for ensuring they have reasonable and appropriate safeguards in place to protect PHI. By diligently adhering to the rule’s requirements, these groups can contribute to the overall security of PHI within the healthcare industry.
Business associates are vendors hired by covered entities to provide services involving PHI, such as billing services for healthcare providers. As they begin to process PHI as part of their job, business associates must also comply with the HIPAA Security Rule and ensure the protection of PHI.
Vendors must maintain the confidentiality, integrity, and availability of all PHI they create, receive, maintain, or transmit on behalf of covered entities. By understanding their responsibilities and implementing appropriate security measures, business associates can contribute to the overall protection of PHI within the healthcare system.
Implementing security measures is crucial for compliance with the HIPAA Security Rule.
The rule requires covered entities and business associates to implement administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of PHI. These safeguards help protect PHI from unauthorized access, modification, or destruction and ensure that only authorized individuals can access the information.
Let’s explore each type of safeguard in detail, starting with administrative safeguards and their role in managing the security of PHI and workforce conduct.
Having policies and procedures in place ensures the selection, development, implementation, and maintenance of security measures to effectively protect electronic and other protected health information.
Furthermore, administrative safeguards also manage the conduct of the covered entity and business associate’s workforce in relation to PHI protection. These safeguards include role-based PHI access, which restricts access to sensitive information to only those who need it.
Information access management policies and workforce training are essential for any workforce members handling PHI. Additionally, a security official is responsible for developing and implementing security policies to ensure compliance with the HIPAA Security Rule. The security management process standard requires covered entities to address potential security violations through risk analysis, sanction policies, and reviews of information system activity.
By adhering to these administrative safeguards, covered entities can ensure the security of ePHI and maintain compliance with the HIPAA Security Rule.
Physical safeguards focus on securing PHI in medical offices, including facility access control and workstation and device security. These safeguards protect the physical structures of a covered entity and business associate and its electronic equipment that stores PHI, along with policies and procedures that secure the information from unauthorized access.
Physical safeguards ensure the safety and security of any physical space by helping to limit physical access.
Facility access and control include a range of measures such as:
Implementing physical safeguards is essential for protecting ePHI from unauthorized access and ensuring compliance with the HIPAA Security Rule.
Technologies, policies, and procedures are used to ensure the safety of protected health information (PHI). Access to this information must be carefully managed and monitored. These safeguards include:
These safeguards are tailored to organizations’ specific needs and risk factors. The principle of least privilege states that only those people who need access to PHI should be granted it. No additional permissions should be given.
Integrity controls help organizations implement policies to prevent unauthorized changes or disposal of PHI. Covered entities and business associates must put technical security measures in place to prevent unauthorized access to PHI when transmitted over an electronic network. All such measures come under the Transmission Security Provisions.
By implementing technical safeguards, covered entities and business associates can effectively secure PHI and maintain compliance with the HIPAA Security Rule. To achieve this, it is crucial to implement technical security measures that align with the requirements of the Security Rule.
Risk analysis and management are essential components of the HIPAA Security Rule.
Conducting a risk assessment helps covered entities and business associates identify potential risks and vulnerabilities that could affect the confidentiality, integrity, and availability of PHI, and implement appropriate security measures based on their findings. Reducing risks to PHI is crucial for maintaining the privacy of individuals and ensuring compliance with the HIPAA Security Rule.
Understanding the process of conducting a risk assessment and mitigating risks is vital for covered entities and business associates.
The HIPAA Security Rule requires covered entities and business associates to perform a risk assessment of their organization to ensure the confidentiality, integrity, and availability of all electronic PHI they create, receive, maintain, or transmit is secure.
The risk assessment process involves identifying potential risks, assessing their probability and impact, and implementing suitable security measures to reduce them. By conducting a thorough risk assessment, covered entities can effectively identify and understand specific risks to ePHI and implement appropriate security measures.
Mitigating risks involves:
By implementing appropriate security measures, covered entities and business associates can effectively reduce risks in accordance with the HIPAA Security Rule.
It is essential to keep up with reviewing and modifying security measures to ensure their effectiveness and adaptability in tackling identified risks. Regularly re-evaluating potential risks allows for the quick identification and mitigation of new or emerging risks.
Compliance with the HIPAA Security Rule requires proper documentation and employee training. Specifically,
Documentation is required for all aspects of HIPAA compliance, including policies and procedures.
Covered entities and business associates must maintain written security policies and procedures and written records of required actions, activities, or assessments for six years after the date of their creation or last effective date.
By maintaining up-to-date records and documentation, covered entities and business associates can demonstrate compliance with the HIPAA Security Rule and ensure that their security measures effectively protect PHI.
Ensuring employee compliance with the HIPAA Security Rule involves training and educating the workforce on the rule’s requirements, such as security awareness topics like password management and recognizing phishing attempts. Employers must monitor their staff’s adherence to security policies and procedures to ensure compliance with the rule.
By providing regular training and holding employees accountable for their actions, organizations can ensure the security of PHI and maintain compliance with the HIPAA Security Rule.
Understanding and implementing the HIPAA Security Rule is crucial for healthcare organizations and their business associates. By focusing on confidentiality, integrity, and availability of ePHI and implementing administrative, physical, and technical safeguards, covered entities and business associates can ensure compliance and maintain the trust of patients.
Through risk analysis, mitigation, and employee training, organizations can stay ahead of potential risks and maintain a secure environment for PHI. Remember, the HIPAA Security Rule is not just a legal obligation but a commitment to the privacy and security of patients’ sensitive health information.
Ready to get started on your path to HIPAA compliance? Let Thoropass help! Streamline compliance with expert guidance, automation, and third-party attestation.
The HIPAA Security Rule consists of administrative, physical, and technical safeguards to protect PHI. Learn more about these standards by visiting the OCR website.
Technical safeguards of HIPAA’s Security Rule protect electronic protected health information and control access to it. These safeguards are defined in 164.312 and include the technology, policy, and procedures related to the use and protection of PHI (Protected Health Information).
These safeguards are designed to ensure that only authorized individuals have access to PHI and that the data is kept secure and confidential. They also ensure that the data is not altered or destroyed.
The key difference between the Security and Privacy Rules within HIPAA is:
Covered entities such as health plans, healthcare clearinghouses, and healthcare providers must comply with the HIPAA Security Rule to protect Protected Health Information (PHI) and implement appropriate security measures.
The HIPAA Security Rule requires organizations to implement administrative, physical, and technical safeguards to protect ePHI. These safeguards must be regularly reviewed and updated to ensure that they remain effective and compliant with the HIPAA Security Rule.
The HIPAA Security Rule has three types of safeguards: administrative, physical, and technical.
HIPAA is required for any business associate or covered entity working with health information. HITRUST demonstrates another level of security that can be beneficial to scaling healthcare organizations.
PHI is a key aspect of healthcare, and knowing how it’s regulated, used, and protected is key to ensuring your healthcare business remains compliant.
Imagine being in a world where yours or your customer’s personal health information could easily fall into the wrong hands, leading to identity theft, medical fraud, and an invasion of privacy. Sounds frightening, right? That’s precisely why understanding the concept of protected health information (PHI) is crucial.
In this blog post, we’ll explore the various dimensions of PHI, including its definition, key components, forms, and the roles of covered entities and business associates. We’ll also discuss the importance of the HIPAA Privacy and Security Rules, de-identification and anonymization processes, what is PHI in healthcare apps and wearable technology, the consequences of PHI breaches and leaks, and best practices for protecting PHI.
PHI is protected health information that is governed by the Health Insurance Portability and Accountability Act (HIPAA). It encompasses a wide range of information, including demographic, medical, and insurance information. Essentially, PHI is individually identifiable health information transmitted (or maintained) in any form (or medium).
Individually identifiable health information is a subset of health information created (or received) by a healthcare provider, health plan, employer, or healthcare clearinghouse that relates to the past, present, or future physical (or mental) health, condition, provision of healthcare, or payment of healthcare that directly or indirectly identifies an individual.
The primary purpose of regulating PHI is to ensure the confidentiality, integrity, and availability of healthcare data. HIPAA-covered entities include:
Covered entities, along with their business associates, maintain trust in the healthcare industry.
Under HIPAA, identifiers determine if the health information is considered PHI. These identifiers include:
These identifiers directly identify an individual and when created or received by a covered entity, are considered protected health information (PHI). The list of identifiers was created to ensure that health data can be identified and traced back to an individual, making it crucial for health insurance companies and healthcare providers to handle them with care.
PHI can come in several forms, such as electronic health records, medical history, test results, and insurance information. Electronic Protected Health Information (ePHI) is a type of PHI. It is created, stored, transmitted, or received in an electronic format. PHI can be present in various documents, forms, and communication channels, like medical bills, insurance forms, and doctor’s notes, which are often handled by healthcare professionals.
Differentiating between paper and electronic PHI records under HIPAA is vital, as there are specific considerations to take into account, like response time for patient requests for access to their data and disposal methods. The identifiers play a critical role in determining if the information is considered PHI according to HIPAA, ensuring that the data is used, shared, and protected properly.
To ensure the proper handling of PHI, HIPAA outlines the roles and responsibilities of covered entities and business associates. Covered entities are healthcare providers, health plans, or healthcare clearinghouses that handle treatment, payment, or operations in healthcare and transmit PHI electronically.
Business associates, on the other hand, are third-party vendors who provide services to a HIPAA-covered entity that creates, receives, maintains, or transmits protected health information on a covered entity’s behalf.
A HIPAA-covered entity is any healthcare provider or insurer that meets the requirements to be considered a HIPAA-covered entity. Examples of covered entities include:
Covered entities must adhere to the HIPAA Privacy,Security, and Breach Notification Rule, which include safeguarding PHI and ensuring compliance with federal regulations.
A business associate is someone outside of the covered entity’s workforce who maintains the ‘persistence of custody’ over protected health information (PHI) on behalf of the covered entity. Examples of business associates include:
Like covered entities, business associates are also subject to enforcement actions by the HHS’ Office for Civil Rights (OCR) and must comply with HIPAA regulations. Ensuring compliance with these regulations helps protect PHI and maintain trust in the healthcare industry.
The HIPAA Privacy and Security Rules are essential components of PHI protection. The Privacy Rule outlines how healthcare organizations can use and disclose PHI, while the Security Rules focus on security measures to protect PHI from unauthorized access. Both covered entities and business associates are subject to these rules, as they play a crucial role in ensuring the proper use, sharing, and protection of PHI.
Organizations must comply with the HIPAA Privacy and Security Rules to ensure that PHI is used appropriately.
The HIPAA Privacy Rule is a federal law that sets standards to protect the privacy of personal health information. It applies to all forms of protected health information, whether it’s electronic, written, or spoken. The Privacy Rule allows healthcare organizations to use and disclose PHI for purposes allowed by the Privacy Rule, without needing authorization from the patient.
The Privacy Rule also grants patients certain rights regarding their PHI, such as the right to access, amend, and get a copy of it. Ensuring compliance with the Privacy Rule is essential for safeguarding patients’ privacy rights and maintaining trust in the healthcare industry.
The HIPAA Security Rule is a set of regulations that require covered entities and business associates to maintain administrative, technical, and physical safeguards for protecting electronic protected health information (ePHI). These safeguards are essential for ensuring the confidentiality, integrity, and availability of PHI.
The Security Rule outlines guidelines for evaluating ePHI, ensuring that covered entities and business associates take the necessary measures to protect their patient’s PHI. By adhering to the Security Rule, healthcare organizations can prevent unauthorized access to PHI and safeguard patients’ privacy rights.
De-identification and anonymization are processes that remove or mask identifiers from PHI data, making it impossible to trace the information back to an individual. These processes allow healthcare data to be used for research and development purposes without compromising patient privacy.
De-identification involves the removal of all identifying details (such as the direct identifiers) or leveraging an expert to make a determination that there is a low probability of identifying an individual within a given data set.
Anonymization is the process of erasing or encrypting identifiers to restrict the ability to link an individual back to an original data set (or stored data). Anonymized PHI is commonly used in clinical and research settings to study health and healthcare trends, as well as to create value-based care programs.
The consequences of PHI breaches and leaks can be severe, including fines, legal penalties, and reputational damage. Financial penalties for breaching PHI can range from $100 to $50,000 for a single accidental violation, with a maximum penalty of $1.5 million yearly for violations of the same provision. In cases of willful neglect or malicious intent, fines can be even higher, and individuals may face prison time of up to 10 years. Reputational damage from PHI breaches and leaks can also have a significant impact on healthcare organizations, leading to loss of trust and potential clients.
Protecting PHI is essential for maintaining patient privacy and trust in the healthcare industry. Investing in cybersecurity, implementing robust privacy policies, and conducting regular risk assessments are some of the best practices for safeguarding PHI.
A comprehensive security program that includes administrative, physical, and technical safeguards is crucial for ensuring the protection of PHI. Moreover, having a strong third-party risk management framework and vendor management policy is essential for covered entities and business associates to ensure the security of PHI throughout the healthcare ecosystem.
Understanding the concept of protected health information (PHI) and the various aspects related to it is crucial for safeguarding patient privacy and maintaining trust in the healthcare industry.
By staying informed and implementing the best practices discussed in this post, healthcare organizations, professionals, and patients can work together to ensure that PHI is used, shared, and protected responsibly. In the ever-evolving world of healthcare, staying vigilant and proactive in safeguarding PHI is essential for maintaining trust and ensuring the future of healthcare innovation.
PHI stands for Protected Health Information and is used to describe all the information collected, stored, or used by healthcare organizations for the diagnosis or treatment of an individual that can be used to personally identify them.
This information is subject to specific security and privacy requirements set out by the HIPAA Privacy Rule.
Protected health information (PHI) includes addresses, dates (such as birth, discharge, and admission dates), and biometric identifiers like finger and voice prints. The full list of identifiers includes:
Covered entities and business associates play a crucial role in protecting PHI, adhering to HIPAA Privacy and Security Rules, and maintaining trust in the healthcare industry.
Healthcare organizations can invest in cybersecurity, implement privacy policies, conduct regular risk assessments, and maintain a strong third-party risk management framework to protect PHI.
Compliance isn’t just required—it’s good business. Leverage this guide to see how you can leverage SOC 2, HITRUST, and HIPAA compliance to help your business stand out in a crowded marketplace.
The HIPAA Minimum Necessary Rule, a subsection of the overarching Privacy Rule, mandates that covered entities and business associates only use and disclose the minimum amount of protected health information (PHI) necessary.
Understanding and complying with the HIPAA Minimum Necessary Rule is more important than ever. In this blog post, we’ll delve into what you need to know about this essential standard and how it safeguards patient privacy.
The HIPAA Minimum Necessary Rule, regulated by the Department of Health and Human Services, is a vital component of protecting patient privacy. The rule’s primary objective is to limit access to PHI to only those who need it for their job roles, ensuring that sensitive patient information remains secure and confidential.
The HIPAA Minimum Necessary Rule mandates that covered entities and business associates only use and disclose the minimum amount of protected health information (PHI) necessary to achieve the intended purpose.
HIPAA is a comprehensive regulation ensuring the proper handling and protection of patient information. The HIPAA Privacy Rule, a part of HIPAA, sets the standards for protecting individuals’ medical records and other protected health information. This rule applies to:
Note that covered entities must comply with all of HIPPA’s Privacy Rules while a specific subset of those rules also apply to their business associates to ensure compliance.
PHI is any information about an individual’s health that is created or received by a healthcare provider, health plan, employer, or healthcare clearinghouse. It can be held or maintained by a covered entity or its business associates and transmitted or stored in any form or medium, including electronic protected health information (ePHI). So long as it’s associated with a past, present, or future medical service, PHI examples can include:
The importance of PHI in relation to the HIPAA Minimum Necessary Rule lies in protecting people’s privacy and ensuring that only authorized individuals access the information.
See how SOC 2, HIPAA, and HITRUST can create the right compliance mix for scaling companies in the healthcare space.
Organizations must take proactive steps to comply with the HIPAA Minimum Necessary Rule. This process involves:
By establishing a strong foundation for handling PHI, organizations can mitigate the risk of unauthorized disclosure and ensure HIPAA compliance.
Creating clear policies and procedures for dealing with PHI is essential to ensure compliance with the HIPAA Minimum Necessary Rule.
Organizations should begin with a written policy outlining the HIPAA Minimum Necessary Standard and how it will be applied within their specific context, including potential exceptions and consequences for non-compliance.
This policy should provide guidelines on limiting the use, disclosure, and request of PHI to the bare minimum necessary to achieve the desired result in various scenarios, such as email exchanges, USB drives, and patient forms.
Robust security measures are crucial for protecting PHI and adhering to the Minimum Necessary Rule. Organizations should implement the following access controls:
These measures complement the Minimum Necessary Standard by ensuring that only essential access is granted.
Cloud service providers (CSPs) must also be considered when implementing security protocols. Contracts with CSPs should outline their responsibilities for storing, destroying, and backing up data, as well as procedures for returning records after contract termination.
Audit logs that monitor access and attempted access to PHI can help organizations detect suspicious activity and prevent potential violations.
Educating staff members on HIPAA regulations and the Minimum Necessary Rule is critical to ensuring compliance within an organization. Employees should be aware of the rule to ensure they only use, disclose, and request the minimum amount of PHI necessary to achieve their objectives. Regular training and guidance can help organizations monitor compliance and address knowledge gaps as needed.
‘Reasonable efforts’ and ‘reasonable reliance’ are two essential concepts related to the HIPAA Minimum Necessary Rule.
Together, these concepts ensure that organizations make rational justifications while using and disclosing PHI, further protecting patient privacy.
Violating the HIPAA Minimum Necessary Rule can result in serious consequences for organizations. These include:
Non-compliance can also have severe repercussions on an organization’s reputation. Loss of customers, decreased revenue, and difficulty regaining public trust are just a few more potential consequences of a HIPAA violation. Organizations must prioritize compliance with the HIPAA Minimum Necessary Rule to avoid these damaging outcomes.
Technology plays a significant role in helping organizations adhere to the HIPAA Minimum Necessary Rule. By implementing monitoring systems and software solutions, organizations can better control access to PHI and ensure that only authorized individuals have access to the necessary information.
Additionally, just-in-time access security measures can grant temporary privileged access within a specific time frame, further limiting unauthorized access to sensitive data.
Organizations should continue to invest in technology solutions and explore innovative ways to enhance the protection of PHI and comply with the HIPAA Minimum Necessary Rule.
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The Minimum Necessary Rule is a part of the Privacy Rule for HIPAA, which requires covered entities to make reasonable efforts to limit access to Protected Health Information (PHI) only to those in the workforce who need it based on their roles in the covered entity.
This means that only those who need access to PHI should be granted access, which should be limited to the minimum necessary required to perform their job.
The three main requirements of HIPAA are:
These rules protect the confidentiality of patient health information by setting standards for how it can be used and disclosed.
Under HIPAA, covered entities and business associates must make reasonable efforts to limit access to Protected Health Information (PHI) to the minimum amount necessary for fulfilling the intended purpose. Access to PHI should be restricted to employees who need it based on their roles.
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Note: This post was originally written and published in March 2020 but has been reviewed, revised, and updated by internal experts.
It can be difficult to translate vague, risk-focused HIPAA requirements into actionable controls and policies. What’s more, it takes significant time, money, and effort to become HIPAA-compliant.Yet many HealthTech companies need HIPAA compliance to grow and thrive. Not only do you need to meet HIPAA requirements to handle certain types of data, but they can’t even dream of working with customers in the health industry without compliance; federal law (and the customers themselves) simply won’t allow it.To help you start to navigate the complexity of HIPAA compliance, we mapped out the most important things you need to know. This resource explains why HIPAA is important for high-growth businesses, how much it costs, what’s involved, and what’s recommended for teams of all sizes pursuing compliance.
Before we dive into HIPAA requirements, let’s walk through what HIPAA is and why you should care about it.
Doctors’ offices, health insurers, and the tech companies that serve them need to meet federal regulatory compliance rules defined by the Health Insurance Portability and Accountability Act (HIPAA). Among many other things, HIPAA sets national security and privacy standards for certain types of health information and is enforced by the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services.However, HIPAA was passed in 1996, at a time before smartphones and tech SMBs. It wasn’t written with today’s health data needs in mind. Since then, lawmakers have updated it several times to better align it with current issues facing the privacy and security of health information.
It depends on the type of business you are. For example, are you a covered entity or a business associate as defined by HIPAA.
HIPAA Privacy Rule, according to the U.S. Department of Health and Human Services, states that: The HIPAA Privacy Rule establishes national standards to protect individuals’ medical records and other individually identifiable health information (collectively defined as “protected health information”) and applies to health plans, healthcare clearinghouses, and those healthcare providers that conduct certain healthcare transactions electronically.
If your business handles patient records (past or present), payment information, or test results, chances are, you’re working with PHI.On its own, health information (like a blood pressure reading) isn’t PHI. Neither is personal information like a name, phone number, or Social Security number. The data is contextual; it depends on where the information came from and how it’s being used or who is using it.
PHI can be a combination of health information and any identifier that could link that information to a specific person.
In many cases, your customers will need your company to comply with HIPAA in order to even consider working with you.HIPAA applies to two types of organizations: covered entities and business associates.
A BAA is a contract that defines how PHI will be used and protected by the business associate. It ensures that the business associate complies with HIPAA and that the covered entity reports and stops working with that vendor if any breaches or violations arise.
But it gets more complicated than that.
Say your SaaS company provides a dashboard that helps healthcare providers manage their PHI. Because you handle PHI for the health care provider, you are a business associate. Data hosting services are considered subcontractors. This is due to the ‘persistence of custody’ over the PHI the services hold for the business associate. Even if the data was encrypted, the data hosting company is still maintaining custody over the PHI data requiring them to comply with HIPAA.
In this scenario, think of your company as the middle link in a chain of HIPAA compliance. You would need a BAA with the health care provider AND the data host. But the data host wouldn’t need a BAA with the health care provider.
Usually, an OCR audit doesn’t happen unless an employee, customer, or vendor reports your lack of compliance. But if something does happen, then you’re subject to some pretty significant fines.The global average total cost of a data breach from 2020-2022 in the healthcare sector was $10 Million. And in the financial industry, it was 5.97 Million.
It’s important to note that actual federal fine amounts depend on the severity of the breach and negligence. The totals also include breach containment and notification costs, business disruption, revenue cost, customer turnover, reputation losses, and other long-term impacts.As mentioned above, companies in the health industry can’t legally work with technology companies without a BAA if PHI is involved. Failing to become HIPAA-compliant means your sales team won’t be able to close deals, and your startup will struggle to move upmarket.
Now that we understand what HIPAA is and why it’s important for SMBs, let’s look at the HIPAA requirements and frameworks that founders need to know.
HIPAA is broken up into three different rules: the Security Rule, the Privacy Rule, and the Breach Notification Rule.
The HIPAA Security Rule establishes administrative, physical, and technical safeguards for electronic PHI. It’s similar to main security frameworks such as NIST SP 800-53 and ISO 27001.In adhering to the HIPAA Security Rule, you’ll need policies and procedures in place to address the following items, among others:Administrative
Physical
Technical
For help translating HIPAA’s Security Rule requirements for your business, check out these resources:
The HIPAA Privacy Rule sets guidelines for what you can and can’t do with PHI. For example, HIPAA’s Privacy Rule
Once part of the Privacy Rule, the Breach Notification Rule, defines a breach and what must be done if one occurs.This rule goes into detail about who needs to be notified, how, and when. For example, the rule stipulates that covered entities must, within 60 days of a breach, send first-class mail or an email informing patients whose PHI was put at risk in the breach. It also defines when businesses have to notify the media and the U.S. Department of Health and Human Services.
Knowing the three aforementioned rules is just the start. Translating them into actionable objectives takes a bit more work. Thankfully, you have some options to help you with this task.
The OCR provides some resources for organizations to become HIPAA-compliant on their own (see above). However, most companies bring in a third-party reviewer, pursue HITRUST certification, or follow a security framework to make sure they do it right.
A reviewer provides an unbiased report about your policies, procedures, and controls through the lens of HIPAA.Like other audits (such as a SOC 2 Type 2 audit), an annual HIPAA Compliance Review should require evidence your company actually executes on your policies and validate these controls. It is highly recommended for you to collect evidence to demonstrate your company’s compliance with your HIPAA policies/procedures. While there isn’t a formal certification for HIPAA, regulators will want to know how effective your controls are, which will then impact their risk analysis requirements.
The Health Information Trust Alliance (HITRUST) is an organization that maintains the HITRUST CSF Common Security Framework, a risk-management framework that pulls from other well-known compliance frameworks (HIPAA, NIST, ISO, PCI).The HITRUST CSF is more prescriptive than HIPAA while covering the necessary controls.
Many companies pair HIPAA with either the NIST SP 800-53 or the ISO 27001 security framework for additional guidance as they pursue HIPAA’s Security Rule.
How much time and money should you expect to spend on meeting HIPAA requirements? It depends on a variety of factors.
In short, you should expect to spend several months preparing for HIPAA compliance, and anywhere from weeks to months on an actual assessment. However, the exact timeline depends on a number of factors:
For example, if you decide to pursue a HITRUST CSF certification, expect to spend upwards of three to six months in the readiness assessment for an r2 HITRUST Certification, and 90 days on the Validated assessment. You also need to ensure the controls are working for at least 90 days before they can be tested. The length of the engagement depends on the type of assessment you choose to pursue. HITRUST offers a readiness-assessment and a validated assessment by a third-party approved External Assessor, such as Thoropass..Keep in mind that HIPAA compliance isn’t a one-and-done affair. You need to renew your compliance every year. This becomes more important for tech organizations as they mature and their size, services, customers, and complexity increase.
HIPAA compliance costs depend on whether you pursue a third-party assessment or you handle everything in-house.It’s important to note that time and cost often go hand in hand. So it should be unsurprising that your HIPAA compliance cost depends on the same factors that determine how long it will take. Team size, complexity and level of risk, documentation, and type of compliance all come into play here.
According to Security Analyst, Jen Stone (MSCIS, CISSP, QSA), if you are a small covered entity, HIPAA could cost anywhere from $4,000-$12,000 and for medium and large covered entities, anywhere upwards of $50,000, depending on your current environment.These costs don’t include indirect impacts, such as opportunity costs and salary dedication for in-house employees, legal fees, or significant process overhauls and technical needs.Spend some time window shopping when you’re ready to settle on a HIPAA-compliance framework or vendor. Thoropass, for example, helps connect its customers with experienced compliance partners via the Thoropass Partner Ecosystem. You may also be able to save some money by asking your customers if they’ll accept a different (less expensive) form of HIPAA validation.
Plus, if you’re part of the AWS Marketplace, you can sign up or renew with Thoropass for 5% back. Reach out to a member of our team today to see if you’re eligible.
Although it’s not easy to become HIPAA-compliant, we can offer several tactics to make the process less challenging.
Oftentimes, teams tend to jump straight to technical controls when they start pursuing a new compliance framework. They see the required controls and believe that the best way to start is by getting those in place — not only to make progress but also to protect their data.
Instead, we recommend that you begin building toward meeting HIPAA requirements with a risk-management program. That is because much of HIPAA evaluation is done using a risk-management methodology.
By understanding the possible risks and risk levels before jumping to controls, you better position yourself to identify and implement more appropriate and effective controls. In putting risk management first, you can actually help yourself prioritize and comply faster in the long run.
Techniques like data aggregation and tokenization help limit the amount of PHI they need to protect as part of HIPAA compliance.
Remember that health information is protected by HIPAA only when it’s combined with all 19 identifiers that can tie that data back to the corresponding individual. Data aggregation presents health information without the identifiers. Alternatively, you can have an expert perform an analysis to determine and confirm there is no way to re-identify individuals.For example, a hospital’s annual report that provides information about intake numbers, average patient age, and other aggregate data would not be considered PHI because it wouldn’t tie any of that health information to the corresponding individuals.
This technique transforms sensitive information into a senseless combination of characters. It’s useful for when you do not need the information (such as PHI or a Social Security number), but you do need to pass this information downstream to a third-party vendor. The PHI then exists within your environment as a token and removes many of the requirements from your systems.
As your company grows, take a hard look at what information you need to collect to serve your customers and what you can leave by the wayside. The less PHI your company needs to handle, the lighter your HIPAA burden.
In 2021, the United States experienced a shortfall of nearly 314,000 cybersecurity professionals. That shortage is expected to grow to 1.8 million in 2022.The lack of compliance experts means that people who want to hire them pay more for their expertise and make sacrifices on whom to bring in, or under what circumstances. This reality makes it more attractive to handle HIPAA compliance in-house.Today, more startups and high-growth SMBs are leaning on compliance solutions like Thoropass to get more breathing room before making a strategic hire or completely replace the need for an external hire.They’re also using a divide-and-conquer approach to handling compliance in-house. That means splitting the responsibility among the team members whose day-to-day jobs already coincide with your security needs. For example, instead of handling HIPAA requirements independently, founders will enlist their engineers to manage HIPAA security controls and assign risk management to an operations team member.
Compliance solutions provide crucial, company-specific guidance for SMBs looking to become HIPAA-compliant.When leaning on Thoropass as you pursue HIPAA compliance, you’ll already know what you need to have in place to meet the expectations of your third-party reviewer. You’ll also have time to work on building your risk-management system at your own pace, so you won’t have to drop everything when the consultant arrives with their list of controls.
We have in-house expertise for all of your compliance needs (HIPAA, ISO, GDPR, SOC 2, HITRUST, etc.). When you work with Thoropass, you get insight across the board, not just on HIPAA-specific things. You’ll have an edge because you’ll understand how different compliance frameworks interact to create the best solution for your specific needs.On a more tactical level, Thoropass makes it much easier to fill out due-diligence questionnaires. Thoropass saves and organizes your responses so you don’t have to start from scratch every time. This cuts down that operational burden to under an hour per questionnaire.
Plus, if you use Amazon Cloud Services, like many of our customers, you can easily renew your Thoropass subscription within the AWS Marketplace and earn 5% back. Speak to a member of our team today to see if your organization is eligible!
HIPAA’s purpose isn’t to drive you mad or to drain your org of critical time, money, or energy. HIPAA’s goal is to protect people and their important medical information.When you invest in HIPAA compliance, you’re not just opening your startup for business with health providers; you’re telling the world that you take the public’s privacy, security, and well-being seriously. What’s more, HIPAA compliance signals to potential customers that your startup is established and trustworthy, giving you an edge over your competition. It’s a solid growth strategy, particularly for startups looking to move upmarket in the health space.
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