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

By | December 2, 2022

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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