HIPAA Compliance News

HHS Proposes New Rule to Implement HIPAA Standards for Healthcare Attachments and Electronic Signatures

Posted by HIPAA Journal

The Secretary of the Department of Health and Human Services (HHS) has proposed a new rule that will require the adoption of standards for healthcare attachments transactions and electronic signatures used in conjunction with those transactions to support healthcare claims and prior authorization transactions. The new rule will implement the requirements of the Administrative Simplification Requirements of HIPAA and the Affordable Care Act and will apply to all health plans, healthcare clearinghouses, and healthcare providers that currently lack an efficient, uniform method of sending attachments.

Currently, when making coverage decisions about healthcare services, health plans often require additional information that cannot be added to the specified fields or data elements of the adopted prior authorization request or healthcare claims transaction. Currently, this information is sent through the mail or by fax and is subject to manual processes that consume considerable time and resources. At present, there are no adopted HIPAA standards, implementation guides, or operating rules covering healthcare attachments or electronic signatures. The proposed rule will support electronic transmissions of this type of information.

“We believe that the health care industry has long anticipated the adoption of a set of HIPAA standards for the electronic exchange of clinical and administrative data to support electronic health care transactions, such as prior authorization of services and claims adjudication, and the standards we are proposing to adopt are an important step in reducing provider burden,” explained the HHS.

The Administrative Simplification Rules of HIPAA called for standard-setting organizations (SSOs) to develop standard code sets for electronic healthcare transactions, and some of these have previously been implemented as part of the Transactions and Code Sets final rule. A rule was also proposed in 2005 – The HIPAA Administrative Simplification: Standards for Electronic Health Care Claims Attachments; Proposed Rule – that required the adoption of standards for health care claims attachment standards for specific service areas, including ambulance services, clinical reports, emergency department, laboratory results, medications, and rehabilitation services; however, based on the comments received, the HHS chose not to finalize that rule.

The American Hospital Association (AHA) has announced its support for the proposed rule and the adoption of a new HIPAA standard for attachments and electronic signatures, as this will ease the burden on providers,/ Currently, the lack of a HIPAA standard for attachment transactions slows down claims processing, leading to delays to payments and patient care, and contributes to provider burnout. “The AHA supports establishing a standard for attachments to reduce the administrative burdens facing clinicians, and we look forward to providing robust commentary after analyzing the rule’s specifics,” said Terrence Cunningham, AHA director of administrative simplification policy.

The proposed rule is scheduled to be published in the Federal Register on December 21, 2022. Comments on the proposed rule must be submitted by March 21, 2022.

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Florida Primary Care Provider Fined $20,000 for HIPAA Right of Access Violation

Posted by HIPAA Journal

The Orlando, FL-based primary care provider, Health Specialists of Central Florida Inc. (HSCF), has paid a $20,000 financial penalty to settle a HIPAA Right of Access case with the HHS’ Office for Civil Rights.

OCR launched an investigation in response to a November 22, 2019, complaint from a woman who had not been provided with a copy of her deceased father’s medical records. The initial request was made in writing on August 29, 2019, and an Authorization for Release of Medical Record Information form was provided to HSCF along with a copy of the original Letters of Administration. It took multiple requests and almost 5 months for all of the requested medical records to be provided. The complete set of records was received by the woman on January 27, 2020.

The HIPAA Right of Access requires healthcare providers to provide a copy of the requested medical records within 30 days of the request being submitted. In certain circumstances, a 30-day extension is applicable. OCR determined that the delay in providing the requested records was a violation of the HIPAA Right of Access. In addition to paying a $20,000 financial penalty, HSCF has agreed to undertake a corrective action plan, which involves developing, implementing, and maintaining HIPAA Privacy Rule policies and procedures concerning the HIPAA Right of Access, distributing those policies and procedures to staff members, and providing training on those policies and procedures. HSCF will also be monitored by OCR for a period of two years from the date of the settlement.

“The right of patients to access their health information is one of the cornerstones of HIPAA, and one that OCR takes seriously. We will continue to ensure that health care providers and health plans take this right seriously and follow the law,” said OCR Director, Melanie Fontes Rainer, announcing the settlement. “Today’s announcement speaks to the importance of accessing information and regulated entities taking steps to implement procedures and workforce training to ensure that they are doing all they can to help patients access.”

The HIPAA Right of Access enforcement initiative was launched by OCR in the fall of 2019. Since then, $2,423,650 has been paid by healthcare providers to resolve HIPAA Right of Access violations in 42 enforcement actions. The fines range from $3,500 to $240,000.

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OCR Fines California Dental Practice for PHI Disclosures on Yelp

Posted by HIPAA Journal

The HHS’ Office for Civil Rights (OCR) has announced a settlement has been reached with a Californian dental practice to resolve multiple HIPAA violations that were identified during investigations of a complaint about impermissible disclosures of protected health information on the review platform Yelp.

New Vision Dental is a Californian general dental practice with offices in South Pasadena and Glendora. On November 29, 2017, OCR received a complaint alleging Dr. Brandon Au, owner and CEO of New Vision Dental, had posted responses to several reviews by patients on Yelp and frequently disclosed protected health information in the responses. In some of the posts, patients were identified and their full names were disclosed, when they had chosen to only use a moniker on the platform. Other information allegedly posted by Dr. Au included detailed information about the patients’ visits, treatment, and insurance, when that information had not been posted publicly by the patients.

The investigation into the impermissible disclosures also included an on-site visit to New Vision Dental. OCR’s investigators were able to confirm that Dr. Au had impermissibly disclosed the protected health information of patients on multiple occasions on Yelp, that the practice did not have the required content in its Notice of Privacy Practices, and had not implemented appropriate policies and procedures concerning protected health information, including the release of protected health information on social media platforms and in public places.

New Vision Dental chose to settle the case and paid a $23,000 financial penalty, has agreed to adopt a corrective action plan to address the aspects of non-compliance identified by OCR, and will be subject to monitoring by OCR for a period of two years.

“This latest enforcement action demonstrates the importance of following the law even when you are using social media.  Providers cannot disclose [the] protected health information of their patients when responding to negative online reviews. This is a clear NO.,” said OCR Director, Melanie Fontes Rainer. “OCR is sending a clear message to regulated entities that they must appropriately safeguard patients’ protected health information. We take complaints about potential HIPAA violations seriously, no matter how large or small the organization.”

This is the 21st financial penalty to be imposed by OCR in 2022 to resolve HIPAA violations – more than in any other year since OCR was given the authority to enforce HIPAA compliance.

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Telehealth Websites are Transmitting Sensitive Health Information to Big Tech Firms

Posted by HIPAA Journal

The private information of visitors to telehealth websites is being shared with big tech companies without user consent due to the use of tracking code snippets on the websites, according to a recent analysis by The Markup.

The websites of 50 direct-to-consumer telehealth companies were analyzed for the presence of third-party tracking code, 49 of which were found to have tracking code that transmitted the information of visitors to third parties, including Meta/Facebook and Google.

The study follows on from an analysis of the websites of the top 100 hospitals in the United States in the summer, which revealed one-third were using tracking code on their websites that was sending data to third parties without consent, valid HIPAA authorizations, or business associate agreements. In a handful of cases, the tracking code was added behind password-protected patient portals.

The latest study of telehealth websites included sites that collect highly sensitive information from visitors, such as the personal and health information of people suffering from Substance Abuse Disorder (SAD) who are seeking treatment. In many cases, the answers to medical questionnaires were also sent to big tech firms from questions relating to that health conditions, medical histories, and drug use.

The report, jointly published by The Markup and STAT, found that 49 of the 50 sites studied transmitted the URLs that an individual had visited, with 35 sites also transferring personal information such as email addresses, phone numbers, and full names. 19 sites recorded and transmitted when the user-initiated checkout, 13 sites sent the answers to questionnaires to third parties, 11 sites sent data confirming when the user had added an item to their cart (such as a treatment plan), and 9 sites transferred the date the user created the account.

The 13 sites that sent questionnaire data were of particular concern, as the answers were to health questions. That information was sent to a variety of companies, including Meta, Google, TikTok, Bing, Snap, Twitter, LinkedIn, and Pinterest. 25 sites told big tech firms when a user had added an item such as a prescription medication to their cart or checked out with a treatment plan.

All but one of the 50 websites transferred the URLs that a user had visited on the site. The websites provide health and treatment information, so the information detailed on certain pages may be for a specific health complaint. That information is then tied to an individual or a household via an IP address. Amazon Clinic was the only website that did not share website data with third parties.

Potential HIPAA Violations

Healthcare providers are HIPAA-covered entities and disclosures of protected health information are restricted by the HIPAA Privacy Rule. SUD information is also subject to the 45 CFR Part 2 Confidentiality of Substance Use Disorder (SUD) Patient Records regulations. Recently, the HHS’ Office for Civil Rights published guidance for HIPAA-regulated entities that confirmed that the use of third-party tracking code on websites violates HIPAA if that tracking code collects and transfers protected health information (PHI) to third parties unless the third party qualifies as a business associate under HIPAA. In such cases, a HIPAA-compliant business associate agreement is required before the code can be used. If a third party is not a business associate, HIPAA-compliant patient authorizations are required before that code can be used.

HIPAA applies to healthcare providers, health plans, healthcare clearing houses, and business associates of those entities, but many of the telehealth sites studied operate in a gray area, as the websites are not run by HIPAA-regulated entities or SUD treatment providers, therefore the HIPAA and Part2 regulations do not apply, even though the data collected is the same data that would be classed as PHI or SUD records if collected by a covered entity.

The information collected through these websites is passed on to HIPAA-covered entities and entities covered by Part 2, but the websites themselves are intermediaries and are therefore not bound by HIPAA or the Part 2 regulations. For example, one website run by Cerebral Inc. collected HIPAA-covered data but is not a HIPAA-covered entity. The website passes the information to Cerebral Medical Group, P.A., which is a HIPAA-covered entity. The transfer of data to the big tech firms occurred before the transfer to the Cerebral Medical Group, P.A.

WorkIt Health provides healthcare services including SUD treatment. Its website states in its Notice of Privacy Practices (NPP) that, “You are receiving this NPP because you are or intend to receive health care services from a Workit Health Clinic… Each Workit Health Clinic together designates themselves as a single Affiliated Covered Entity (“ACE”) for purposes of compliance with HIPAA.” However, the WorkIt website had trackers from Google, Facebook, Bing, and Twitter, and transferred URLs, personal information, and answers to questionnaires. The Markup contacted WorkIt Health regarding the findings of the study and WorkIt Health removed the tracking technology from its website and initiated an investigation into the privacy breach.

Visitors to These Websites Expect Privacy

Many healthcare organizations add these tracking technologies to their websites with good intentions, as the technology can provide data that can help to improve the user experience on websites and gauge the effectiveness of marketing campaigns, but the extent to which patient information is being shared is not fully understood.

Individuals who visit these websites are unlikely to be aware that any information they provide directly through answers on web forms and medical questionnaires, and indirectly via the sites they visit, is not being kept private and confidential, and that is a big concern. Many of these sites mention HIPAA and Part 2 in their NPPs, yet the extent to which those regulations apply is unclear. The Markup notes that at least 12 of the studied companies state that they are HIPAA compliant, but that does not necessarily mean that the information provided on the site is kept private or is indeed covered by HIPAA at the point it is collected.

The study shows that there is a trade-off when using these websites. Patients get convenience, but it may come at the expense of their privacy. There is a massive gap in HIPAA, which has not been updated to account for changes in how healthcare is being provided, and there are also suggestions of deceptive privacy practices, albeit in many cases unwittingly deceiving visitors about privacy.

“Sensitive health information is being shared, inadvertently, online every day. Hospital websites, online pharmacies, and health information sites, use a variety of applications (site analytics, links to social media, advertising) that collect and share site visitors’ data, including the healthcare terms and medical conditions that the user is searching,” Ian Cohen, CEO of LOKKER told HIPAA Journal. “For example, in LOKKER’s recent research of over 170,000 websites, we identified the Meta Pixel (Facebook) on over 40% of healthcare sites. Similar data was found about data being shared with TikTok, Snapchat, Pinterest, Microsoft, and Google, as well.” Cohen went on to say, “Not only are consumers and patients unaware that their information is being collected and shared, we believe that the website owners don’t fully understand the extent to which they are sharing data back to the social networks.”

The Markup explained that its researchers did not test all webpages on the sites of the telehealth providers, so the full extent to which tracking code has been used is not known. Tracking code can also be configured differently on different web pages.

It is also unclear what the big tech firms do with the transferred data. Several big tech firms state that they do not allow targeted advertising related to health conditions, although there are ways around that by using closely related terms. Meta, for instance, claims to strip out any data it should not receive and does not provide that information to third-party advertisers. The extent to which that occurs is also unclear. Meta is the subject of several lawsuits over this very matter, some of which allege health data has been used to serve targeted ads to patients whose information was collected through the Meta Pixel code snippet.

Steps Operators of Health Websites Should Take

The HHS’ Office for Civil Rights has made clear in its recent guidance that tracking technology on websites violates HIPAA and that this issue needs to be addressed immediately. HIPAA-regulated entities are required to report any HIPAA violations related to the use of third-party tracking technologies. So far, only a few HIPAA-regulated entities have done so, despite huge numbers having added tracking code to their websites. Even if the websites are not run by HIPAA-regulated entities, the operators of those websites have a moral responsibility to protect the privacy of their visitors with respect to their sensitive health information. Ian Cohen suggests all healthcare organizations should take the following actions:

  1. Take inventory of what data your websites and apps are collecting and if you’re violating your own privacy policy, other privacy laws, or your customers’ trust
  2. Know your partners and ensure they aren’t exploiting your customers’ information
  3. Build customer privacy ‘muscle’ by forming teams that include Marketing, IT, and Legal and establish routines for better data hygiene
  4. Don’t just ask for customer consent for bad practices, re-evaluate how you want to better serve your customers and build trust with every interaction by communicating clearly

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Amazon Ends Support for Third Party HIPAA-Eligible Alexa Skills

Posted by HIPAA Journal

Amazon has announced that it will stop support for third-party HIPAA-eligible skills for its Alexa devices, which means developers will no longer be able to create Alexa skills that collect data covered under the Health Insurance Portability and Accountability Act (HIPAA).

Amazon launched its HIPAA-compliant Alexa feature in April 2019, with skills added for patients of Atrium Health, Boston Children’s Hospital, Cigna, Express Scripts, Livongo, and Swedish Health Connect. The HIPAA compliance support meant healthcare organizations could use Alexa skills that collected HIPAA-protected data and could transmit that information in a HIPAA-compliant way. The decision has now been taken to end that support. HIPAA-eligible skills are now part of the Alexa Smart Properties for Healthcare business unit, and those skills can only be developed with first-party support.

“We regularly review our experiences to ensure we are investing in services that will delight customers. We are continuing to invest heavily in developing healthcare experiences with first and third-party developers, including Alexa Smart Properties for Healthcare,” explained Amazon in a statement.

Amazon has now written to all third-party developers to advise them that support for Alexa 3P HIPAA-eligible skills comes to an end this week and has advised them to remove their HIPAA-eligible skills from the skills store. Any developer that fails to remove the skill from the store will have it removed automatically on December 9, 2022, and the use of that skill will be suppressed. Any protected health information associated with that skill will be deleted and if any user attempts to use a HIPAA-eligible skill after it has been suppressed, they will receive a message that the skill is no longer supported. Amazon has confirmed that it will not be notifying users of the skills directly to advise them that support is ending.

The ending of support for third-party HIPAA-eligible skills does not mean that all healthcare-related Alexa skills will be suppressed, only those that collect protected health information. Any healthcare-related Alexa skills that do not collect data protected under HIPAA will be unaffected.

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OCR Confirms Use of Website and Other Tracking Technologies Without a BAA is a HIPAA Violation

Posted by HIPAA Journal

The HHS’ Office for Civil Rights has issued a bulletin confirming that the use of third-party tracking technologies on websites, web applications, and mobile apps without a business associate agreement (BAA) is a HIPAA violation if the tracking technology collects and transmits individually identifiable health information. Even with a BAA in place, the use of the tracking technology may still violate the HIPAA Rules

The bulletin has been issued in response to the discovery earlier this year that Meta Pixel tracking code was being extensively used on the websites of hospitals and that the code snippet transferred data to Meta, including sensitive patient data. These privacy breaches came to light during an investigation by The Markup and STAT, which found Meta Pixel had been added to the websites of one-third of the top 100 hospitals in the United States and, in 7 cases, the code had been added to password-protected patient portals. The study was limited to the top 100 hospitals, so it is likely that hundreds of hospitals have used the code and have – in all likelihood unwittingly – transferred sensitive data to Meta/Facebook without a business associate agreement in place and without obtaining patient consent.

Following the publication of the report, several lawsuits were filed against healthcare providers over these impermissible disclosures, with some plaintiffs claiming the information disclosed on the websites of their healthcare providers had been transferred to Meta and was used to serve them targeted advertisements related to their medical conditions. The news came as a shock to healthcare providers, triggering investigations and recent data breach notifications; however, despite so the widespread use of the tracking code, only a handful of hospitals and health systems have reported the breach and have sent notifications so far. The bulletin from the HHS is likely to trigger a flurry of breach notifications as providers realize that the use of Meta Pixel and other tracking code constitutes a HIPAA violation.

What are Tracking Technologies?

Tracking technologies are commonly snippets of code that are added to websites, web applications, and mobile apps for tracking user activity, typically for determining the journeys of users while using websites and monitoring their on-site interactions. The data collected by these technologies can be analyzed and used to improve the services provided through the websites and applications and enhance the user experience, which benefits patients. While there are benefits to individuals from the use of this code, there is also considerable potential for harm to be caused, as in addition to providing a HIPAA-regulated entity with useful information, the data collected through these technologies is usually transmitted to the vendor.

For instance, if a female patient arranged an appointment on the website of a healthcare provider to discuss the termination of a pregnancy, the tracking technology on the site could be transmitted to the vendor, and subsequently disclosed to other third parties. That information could be provided to law enforcement or other third parties. Information disclosed in confidence by a patient of a website or web application could be transferred to a third party and be used for fraud, identity theft, extortion, stalking, harassment, or to promote misinformation.

In many cases, these tracking technologies are added to websites and applications without the knowledge of users, and it is often unclear how any disclosed information will be used by a vendor and to whom that transmitted information will be disclosed. These tracking technologies often use cookies and web beacons that allow individuals to be tracked across the Internet, allowing even more information to be collected about them to form detailed profiles. When tracking technologies are included in web applications, they can collect device-related information, including location data which is tied to a unique identifier for that device, through which a user could be identified.

All Tracking Technologies Must be HIPAA Compliant

There is nothing in HIPAA that prohibits the use of these tracking technologies, but the HIPAA Rules apply when third-party tracking technologies are used, if the tracking technology collects individually identifiable information that is protected under HIPAA and if it transmits that information to a third party, be that the vendor of the tracking technology or any other third-party. If the tracking technology collects any identifiers, they are classed as protected health information because the information connects the individual to the regulated entity, indicating the individual has received or will receive health care services or benefits from the regulated entity, and that relates to the individual’s past, present, or future health or health care or payment for care.

There is an elevated risk of an impermissible disclosure of PHI when tracking technology is used on patient portals or any other pages that require authentication as these pages usually have access to PHI. If tracking code is added to these pages it must be configured in a way to ensure that the code only uses and discloses PHI in compliance with the HIPAA Privacy Rule, and that any information collected is secured in a manner compliant with the HIPAA Security Rule. Tracking code on unauthenticated pages also has the potential to have access to PHI. The same applies to tracking technologies within a HIPAA-regulated entity’s mobile apps, if it collects and transmits PHI. OCR confirmed that only mobile apps offered by healthcare organizations are covered by HIPAA. HIPAA does not apply to third-party apps that are voluntarily downloaded by individuals, even if the apps collect and transmit health information.

“Regulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of PHI to tracking technology vendors or any other violations of the HIPAA Rules,” explained OCR in the bulletin.

The OCR bulleting confirms that if tracking technologies are used, the provider of that code – which includes Meta Platforms (Meta Pixel) and Google (Google Analytics) – would be classed as a business associate and must enter into a business associate agreement (BAA) with the HIPAA-regulated entity before the code can be added to a website or application. The BAA must state the responsibilities of the vendor with respect to the PHI and specify the permitted uses and disclosures of that information. If the vendor will not sign a BAA, PHI cannot legally be provided to that vendor, therefore the code cannot be used or must be configured in a way that it does not collect or transmit PHI. OCR also confirmed that if a vendor states that they will strip out any identifiable information prior to saving or using the transferred data, such a disclosure to the vendor would still only be permitted if a BAA was signed and if the HIPAA Privacy Rule permits such a disclosure.

Other potential violations of HIPAA could occur. If any PHI is disclosed to a vendor, it must be in line with the organization’s privacy policy and be detailed in their Notice of Privacy Practices. It is important to note that simply stating that tracking technology is used in a notice of privacy practices is not sufficient by itself to ensure compliance. In addition to a BAA, any disclosure of PHI for a purpose not expressly permitted by the HIPAA Privacy Rule requires a HIPAA-compliant authorization from a patient, giving their consent to disclose that information. Website banners that ask a website visitor to consent to cookies and the use of web tracking technologies do not constitute valid HIPAA authorizations.

Actions HIPAA-Regulated Entities Should Take Immediately

In light of the bulletin, HIPAA-regulated entities should read it carefully to make sure they understand how HIPAA applies to tracking technologies. They should also conduct a review of any tracking technologies that they are using on their websites, web applications, or mobile apps to ensure those technologies are being used in a manner compliant with the HIPAA Rules. If they are not already, website tracking technologies must be included in a HIPAA-regulated entity’s risk analysis and risk management processes.

It is important to state that a tracking technology vendor is classed as a business associate under HIPAA, even if a BAA is not signed. As such, any disclosures to that vendor would be classed as an impermissible disclosure of PHI without a BAA in place, and the HIPAA-regulated entity would be at risk of fines and other sanctions if PHI is transmitted without a signed BAA.

If during the review a HIPAA-regulated entity discovers tracking technologies are being used in a manner not compliant with the HIPAA Rules, or have been in the past, then the HIPAA Breach Notification Rule applies. Notifications will need to be sent to OCR and the individuals whose PHI has been impermissibly disclosed.

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HHS, SAMHSA Propose Update to Improve Alignment of HIPAA Privacy Rule and 42 CFR Part 2

Posted by HIPAA Journal

The Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) have issued a Notice of Proposed Rulemaking (NPRM) detailing changes to the Confidentiality of Substance Use Disorder (SUD) Patient Records (42 CFR Part 2) and HIPAA to increase care coordination and better align Part 2 with the HIPAA Privacy Rule, as required by Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

Part 2 protects patient privacy and records related to treatment for SUD and the HIPAA Privacy Rule is concerned with the privacy of protected health information (PHI); however, SUD records are treated differently from other types of PHI. The HIPAA Privacy Rule permits disclosures of protected health information without consent for treatment, payment, or healthcare operations, but Part 2 imposes greater restrictions on disclosures of SUD records. Generally, SUD records can only be disclosed by a SUD treatment provider if consent to do so is obtained from the patient. Further, even with a valid consent form, SUD treatment providers must include a written statement that the information cannot be redisclosed. This is because SUD records are particularly sensitive due to the stigma of substance abuse and the potential discrimination, which can potentially result in loss of insurance and employment.

Having to treat PHI and SUD records differently is problematic as it creates barriers to information sharing that is in the best interests of patients and the dual compliance obligations creates compliance challenges for regulated entities. “Varying requirements of privacy laws can slow treatment, inhibit care, and perpetuate negative stereotypes about people facing substance use challenges,” HHS Secretary Xavier Becerra, hence the need for better alignment of Part 2 with the HIPAA Privacy Rule. It is important, however, to ensure patient privacy, as any lessening of the protections for SUD records could deter individuals suffering from SUD from seeking treatment, which could have life-threatening consequences.

The proposed rule strikes a balance between the need for strong privacy protections and having the flexibility to allow information sharing to improve care coordination. “One of SAMHSA’s priorities is working to make effective treatments and recovery supports for SUD more accessible to all Americans,” said Miriam E. Delphin-Rittmon, Ph.D., the HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA. “Bringing Part 2 requirements into closer alignment with HIPAA will support more effective coordination for people accessing care. At the same time, the proposed rule mitigates the discrimination and stigma that we know too often people with SUDs experience.”

The key changes in the NPRM are:

  • Permitted use and disclosure of Part 2 records will be based on a single patient consent. Once that consent is given, it covers all future uses and disclosures for treatment, payment, and healthcare operations.
  • Redisclosure of Part 2 records will be permitted – with certain exceptions – if redisclosure is permitted by the HIPAA Privacy Rule.
  • Patients are given new rights under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as also granted by the HIPAA Privacy Rule.
  • Prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings have been expanded.
  • The HHS has new enforcement authority and can impose civil money penalties for violations of Part 2, in line with HIPAA and the HITECH Act
  • Part 2 programs must establish a process to receive complaints about Part 2 violations, those programs are prohibited from taking adverse action in response to complaints, and must not require patients to waive the right to file a complaint as a condition of providing treatment, enrollment, payment, or eligibility for services.
  • Breach notification requirements to the HHS and affected patients for Part 2 records will be aligned with the HIPAA Breach Notification Rule.
  • The HIPAA Privacy Rule Notice of Privacy Practices requirements have been updated to address uses and disclosures of Part 2 records and individual rights with respect to those records.

The HHS and SAMHSA are encouraging healthcare industry stakeholders and the public to submit comments on the proposed changes. To be considered, they must be submitted within 60 days of publication of the NPRM in the Federal Register. The expected publication date is 12/02/2022. A fact sheet on the proposed changes has been published on the HHS website.

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HHS, SAMHSA Propose Update to Improve Alignment of HIPAA Privacy Rule and 42 CFR Part 2

Posted by HIPAA Journal

The Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) have issued a Notice of Proposed Rulemaking (NPRM) detailing changes to the Confidentiality of Substance Use Disorder (SUD) Patient Records (42 CFR Part 2) and HIPAA to increase care coordination and better align Part 2 with the HIPAA Privacy Rule, as required by Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

Part 2 protects patient privacy and records related to treatment for SUD and the HIPAA Privacy Rule is concerned with the privacy of protected health information (PHI); however, SUD records are treated differently from other types of PHI. The HIPAA Privacy Rule permits disclosures of protected health information without consent for treatment, payment, or healthcare operations, but Part 2 imposes greater restrictions on disclosures of SUD records. Generally, SUD records can only be disclosed by a SUD treatment provider if consent to do so is obtained from the patient. Further, even with a valid consent form, SUD treatment providers must include a written statement that the information cannot be redisclosed. This is because SUD records are particularly sensitive due to the stigma of substance abuse and the potential discrimination, which can potentially result in loss of insurance and employment.

Having to treat PHI and SUD records differently is problematic as it creates barriers to information sharing that is in the best interests of patients and the dual compliance obligations creates compliance challenges for regulated entities. “Varying requirements of privacy laws can slow treatment, inhibit care, and perpetuate negative stereotypes about people facing substance use challenges,” HHS Secretary Xavier Becerra, hence the need for better alignment of Part 2 with the HIPAA Privacy Rule. It is important, however, to ensure patient privacy, as any lessening of the protections for SUD records could deter individuals suffering from SUD from seeking treatment, which could have life-threatening consequences.

The proposed rule strikes a balance between the need for strong privacy protections and having the flexibility to allow information sharing to improve care coordination. “One of SAMHSA’s priorities is working to make effective treatments and recovery supports for SUD more accessible to all Americans,” said Miriam E. Delphin-Rittmon, Ph.D., the HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA. “Bringing Part 2 requirements into closer alignment with HIPAA will support more effective coordination for people accessing care. At the same time, the proposed rule mitigates the discrimination and stigma that we know too often people with SUDs experience.”

The key changes in the NPRM are:

  • Permitted use and disclosure of Part 2 records will be based on a single patient consent. Once that consent is given, it covers all future uses and disclosures for treatment, payment, and healthcare operations.
  • Redisclosure of Part 2 records will be permitted – with certain exceptions – if redisclosure is permitted by the HIPAA Privacy Rule.
  • Patients are given new rights under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as also granted by the HIPAA Privacy Rule.
  • Prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings have been expanded.
  • The HHS has new enforcement authority and can impose civil money penalties for violations of Part 2, in line with HIPAA and the HITECH Act
  • Part 2 programs must establish a process to receive complaints about Part 2 violations, those programs are prohibited from taking adverse action in response to complaints, and must not require patients to waive the right to file a complaint as a condition of providing treatment, enrollment, payment, or eligibility for services.
  • Breach notification requirements to the HHS and affected patients for Part 2 records will be aligned with the HIPAA Breach Notification Rule.
  • The HIPAA Privacy Rule Notice of Privacy Practices requirements have been updated to address uses and disclosures of Part 2 records and individual rights with respect to those records.

The HHS and SAMHSA are encouraging healthcare industry stakeholders and the public to submit comments on the proposed changes. To be considered, they must be submitted within 60 days of publication of the NPRM in the Federal Register. The expected publication date is 12/02/2022. A fact sheet on the proposed changes has been published on the HHS website.

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Cybersecurity is Now a Patient Safety Issue, Suggests Sen. Warner In Congressional Report

Posted by HIPAA Journal

Senator Mark Warner (D-VA), Chairman of the Senate Select Committee on Intelligence, has recently published a white paper – Cybersecurity is Patient Safety – that highlights the current cybersecurity challenges facing the healthcare industry and suggests several potential policy changes that could help to improve healthcare cybersecurity and better protect all health information, including health data not currently protected under the HIPAA Rules.

Sen. Warner suggests the only way to improve healthcare cybersecurity rapidly is through a collaborative effort involving the public and private sectors, with the federal government providing overall leadership. While further regulation may be necessary, the overall consensus of healthcare industry stakeholders is the best approach is to introduce incentives for improving cybersecurity, rather than mandating cybersecurity improvements with a threat of financial penalties for noncompliance.

The healthcare industry is under attack from cybercriminals and nation-state threat actors and cyberattacks and data breaches are increasing at unacceptable levels. In 2021, 45 million Americans had their sensitive personal and healthcare exposed or stolen in healthcare industry cyberattacks. More must be done to improve resilience and deal with the increasing threats. “Unfortunately, the healthcare sector is uniquely vulnerable to cyberattacks and the transition to better cybersecurity has been painfully slow and inadequate,” said Senator Warner. “Cybersecurity can no longer be viewed as a secondary concern; it must become incorporated into every organization’s – from equipment manufacturers to health care providers – core business models.”

The white paper suggests several areas where policies could be changed to improve cybersecurity in the healthcare industry.

Improve Federal Leadership

The Department of Health and Human Services (HHS) is the Sector Risk Management Agency (SRMA) for the healthcare industry, but within the HHS agencies such as the Office for Civil Rights (OCR), Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA) have their own jurisdictions and cybersecurity policies. The white paper explains that there is a lack of overall leadership and suggests a senior leader should be appointed, who should be “empowered—both operationally and politically—to ensure HHS speaks with one voice regarding cybersecurity in health care, including expectations of external stakeholders and the government’s role.”

Modernize HIPAA

HIPAA was enacted in 1996, and the HIPAA Privacy and Security Rules have been in place for two decades, and while updates have been made to the HIPAA Rules, they fail to fully address emerging threats to the confidentiality, integrity, and availability of healthcare data. The current focus is on protecting the healthcare data collected, stored, and transmitted by HIPAA-regulated entities, but the same information is collected, stored, and transmitted by entities that are not bound by the HIPAA Rules. It has been suggested that more sensitive healthcare data is now being collected by health apps than is collected and stored by HIPAA-regulated entities, yet this data is largely unregulated. The white paper suggests Congress should direct the HHS to update HIPAA and expand the definition of covered entities and stipulate the allowable uses and disclosures of health data by entities that are not currently classed as HIPAA-regulated entities, to address the gap between HIPAA and the FTC Health Breach Notification Rule.

Develop a Healthcare-Specific Cybersecurity Framework

The National Institute of Standards and Technology (NIST) has released its Framework for Improving Critical Infrastructure Cybersecurity, and while that work has been commended, many healthcare industry stakeholders want more detailed guidance from NIST that is specific to the healthcare industry and have called for NIST develop a consensus-based healthcare-specific cybersecurity framework.

Improve Security Incident Preparedness and Response

The HHS recently stressed in its October Cybersecurity newsletter the importance of security incident preparedness and planning, as cyberattacks are inevitable in the lifespan of a healthcare organization. More needs to be done to encourage healthcare organizations to prepare for attacks. The HHS could direct healthcare facilities to consider cyberattacks to be equivalent to natural disasters such as hurricanes and earthquakes, including mandating training of hospital staff to use analog equipment and legacy systems, and to establish a disaster relief program for victims of cyberattacks.

Incentivize Healthcare Providers to Replace Legacy Systems

Legacy systems are still extensively used in the healthcare industry, despite software and operating systems reaching end-of-life and having support withdrawn. Legacy systems are a security risk, yet healthcare organizations continue to use them as they continue to function and the cost of replacing them is too high. Incentives should be offered to phase out these legacy systems, such as a program similar to the 2009 Car Allowance Rebate System (CARS) that encouraged people to trade in their old vehicles.

Improve Medical Device Cybersecurity

There is considerable concern about the cybersecurity of medical devices and a need for minimum standards of security to be maintained and good cyber hygiene practices followed. There is a need for all software and devices to be supplied with a software bill of materials (SBOMs), and for security requirements to be required during pre-market approval, as proposed by the PATCH Act. The white paper also suggests restrictions could be imposed on the sale of medical devices that have software that has reached end-of-life and is no longer supported, and for healthcare organizations to be incentivized to invest in systems for tracking medical equipment.

Address the Current Cybersecurity Talent Shortage

There is currently a global shortage of cybersecurity professionals that is unlikely to be resolved in the short to medium term. Healthcare organizations struggle to recruit the necessary talent and many cybersecurity positions in healthcare remain unfilled. The white paper suggests one way to address the shortage would be for Congress to create a workforce development program and to incentivize individuals to take on cybersecurity positions in healthcare, such as offering student loan forgiveness for cybersecurity professionals who commit to serving in rural communities, similar to the National Health Service Corps Loan Repayment Program.

Reduce the Cost of Cyber Insurance

Cyber insurance is becoming increasingly expensive and there is an extensive and burdensome application process. The white paper suggests a federal reinsurance program could be introduced to cover plans that require minimum cyber hygiene standards to be maintained, which could help the industry achieve minimum cyber hygiene standards without government mandates. The program would standardize coverage elements and provide incentives for insurance companies to adopt them. This could lower overall risks, which could help to reduce the cost of insurance.

Senator Warner is seeking feedback on the white paper from businesses, advocacy groups, researchers, and individuals. Comments should be submitted no later than December 1, 2022.

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