Last month, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a bulletin with guidance concerning the use of online tracking technologies by covered entities and business associates under the Health Insurance Portability and Accountability Act (HIPAA). The OCR Bulletin follows a significant uptick in litigation concerning these technologies in industries including but not limited to the healthcare. For healthcare entities, the allegations relate to the sharing of patient data obtained from patient portals and websites.

THE OCR BULLETIN

A Few Reminders

Before digging into the OCR Bulletin, let’s remember a few basic HIPAA rules:

• In general, the HIPAA privacy and security regulations (the “HIPAA rules”) apply only to “covered entities” and “business associates” (we’ll call these “regulated entities”).

• The HIPAA Rules apply to “protected health information” (PHI) which generally includes individually identifiable health information. That is, health information that relates to the individual’s past, present, or future health, health care, or payment for care, including demographic information. See 45 CFR 160.103.

• Regulated entities can use or disclose PHI without an individual’s written authorization only as expressly permitted or required by the HIPAA Rules. See 45 CFR 164.502(a).

Definition of Tracking Technologies and Their Uses

As discussed in the OCR Bulletin, an online tracking technology is

“a script or code on a website or mobile app used to gather information about users as they interact with the website or mobile app“

Examples of these tracking technologies on websites include cookies, web beacons, or tracking pixels. Mobile apps may use tracking technologies such as tracking codes within the app, as well as captures of device-related information. As noted in the Bulletin,

“For example, mobile apps may use a unique identifier from the app user’s mobile device, such as a device ID or advertising ID. These unique identifiers, along with any other information collected by the app, enable the mobile app owner or vendor or any other third party who receives such information to create individual profiles about each app user“

Tracking technologies, whether developed internally or by third parties, are used by website or mobile app owners for various reasons, including to better understand the user experience on their site or app. Technologies developed by third parties may be able to track users and gather information after they navigate away from the original site. The OCR Bulletin focuses on third party tracking technologies.  

Why Do Tracking Technologies Trigger HIPAA?

When a regulated entity uses tracking technologies developed by a third party vendor on its mobile app or website, such use may result in the collection and/or disclosure of PHI to the third party.

The Bulletin states:

All such IIHI collected on a regulated entity’s website or mobile app generally is PHI, even if the individual does not have an existing relationship with the regulated entity and even if the IIHI, such as IP address or geographic location, does not include specific treatment or billing information like dates and types of health care services.

(emphasis added.) So, according to the OCR, individuals with or without an existing patient relationship with the regulated entity could be sharing PHI with the entity (or a third party) through its website tracking technologies. This information might include an individual’s medical record number, home or email address, or dates of appointments, as well as an individual’s IP address or geographic location, medical device IDs, etc.

Notably, not all such technologies will be collecting identifiable information. The Bulletin recognizes a distinction between user-authenticated and unauthenticated webpages. User-authenticated pages require a user to log in before access to the regulated entity’s page. According to the Bulletin, information collected on a user-authenticated webpage will be presumed to be PHI and subject to HIPAA.

Many regulated entities maintain unauthenticated webpages – those that do not require a log in for access. Typically, these are sites that provide general information only – locations, description of services, policies and procedures etc., and generally do not have access to PHI. For unauthenticated web pages, the determination is more detailed as tracking technologies on such webpages typically would not have access to PHI. However, regulated entities should be aware that tracking on such pages could capture PHI. Sites that address specific symptoms or health conditions, or that permit a visitor to search for a doctor or schedule an appointment may qualify as PHI, where, for example, the visitor’s email address or IP address is also captured.

Importantly, the Bulletin clarifies the HIPAA Rules do not apply to websites or mobile apps that are developed or offered by entities that are not regulated entities. For instance, a mobile app provider may offer individuals an online repository or tracking feature for their sensitive health information. If that provider if not a regulated entity, the HIPAA Rules do not apply, although other federal and/or state laws may, such as Federal Trade Commission (FTC) Act or state comprehensive privacy laws, such as the California Consumer Privacy Act. Notably, in September 2021, the FTC issued a policy statement confirming that covered companies (e.g., certain health apps) that hold fertility, heart health, glucose levels and other health data must notify consumers in the event of a breach.  

HIPAA Obligations When Using Tracking Technologies

When a regulated entity uses tracking technologies on its website(s) or mobile app(s), it may have obligations under the HIPAA Rules. While we cannot cover all of those requirements here, we summarize some key obligations:

• Investigate whether the site or app has access to PHI. As noted above, do not assume that because the site is unauthenticated or only collects email addresses, it is not collecting PHI.  

• Ensure that all disclosures of PHI to tracking technology vendors are specifically permitted by the Privacy Rule and that unless an exception applies, only the minimum necessary PHI to achieve the intended purpose is disclosed.

  • Remember that if a disclosure of PHI requires an authorization under HIPAA, website privacy policies and website banners that ask users to accept or reject the use of tracking activities, standing alone, will be unlikely to constitute a valid authorization.

  • If a tracking technology vendor is creating, receiving, maintaining, or transmitting PHI on behalf of a regulated entity for a covered function, it will likely be considered a business associate. In that case, a business associate agreement may need to be in place between the regulated entity and the vendor.

• Address the use of tracking technologies in a risk analysis and risk management processes, and implement safeguards in accordance with the HIPAA security regulations.

• Provide breach notifications to affected individuals and the OCR if impermissible disclosures of PHI occur via tracking technology.

LITIGATION.

During 2022, litigation concerning the use of website tracking technologies increased significantly. In one report, a health system settled claims for $18 million, while in another case, the plaintiffs alleged over 650 hospital system or medical provider websites use the Meta Pixel tracking tool and have sent data from those sites.

The trend does not just involve HIPAA regulated entities or HIPAA. According to a Bloomberg Law analysis, between February and October 2022, at least 47 proposed class actions were filed alleging transfers of “personal video consumption data from online platforms to Facebook without their consent,” in violation of the federal Video Privacy Protection Act.

For regulated entities under HIPAA, it is not much comfort that HIPAA does not have a private right of action for individuals. Plaintiffs are using other paths under similar federal and state laws to advance their claims. The trend is growing, but there are steps regulated entities can take to address these risks.

NEXT STEPS

Covered entities and business associates should conduct an audit of any tracking technologies used on their websites, web applications, or mobile apps and determine if they are being used in a manner that complies with HIPPA. Such tracking technologies should be included in a HIPAA risk analysis and risk management process.

Covered entities should review tracking technology vendor agreements and ensure a business associate agreement is in place to avoid potential impermissible disclosure of private health information.

If through an audit it is found that tracking technologies are being used in a manner not compliant with HIPAA, notification may be required under HIPAA and applicable state law.