Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee, published on February 21, 2024, a white paper with various proposals to update privacy protections for health data. In Part 1 of this blog series (see here), we discussed the first section of Senator Cassidy’s February 21, 2024, white paper. Specifically, we summarized Senator Cassidy’s proposals on how to update the existing framework of the Health Insurance Portability and Accountability Act, as amended, and its implementing regulations (collectively, “HIPAA”) without disrupting decades of case law and precedent. In this blog post, we discuss the other sections of the white paper, namely proposals to protect other sources of health data not currently covered by HIPAA.

Health Data in the HIPAA “Gray Area”

Senator Cassidy’s white paper explains that, while the existing HIPAA framework has functioned well, there are gaps between consumer/patient expectations and the actual protections. The white paper calls on Congress to legislate to address these “gray areas,” which include:

• Genetic Data. The white paper discusses how genetic data collected by direct-to-consumer (“DTC”) companies is not subject to HIPAA and may be used beyond the original scope of the intended use when the sample was collected. The white paper proposes that DTC genetic testing companies be required to disclose to consumers that the data they collect is not subject to HIPAA and further proposes that Congress pass legislation to create “appropriate notice and consent requirements.” Senator Cassidy points to DTC genetic privacy laws enacted in several states that require patient consent for use of genetic data as examples of a potential legislative model. Further, Senator Cassidy calls on Congress to consider how to expand research protections for genetic data collected by DTC genetic testing companies, such as by implementing certain human subject research protections similar to those in the federal Common Rule.

• Wellness and Wearables Data. The white paper calls on Congress to require developers of wellness applications to notify consumers that any information generated by the wellness app is not covered by the HIPAA framework to allow consumers to determine whether they are comfortable using that particular app. The white paper also highlights that data from wearable devices, such as smart watches and similar technologies, are generally not protected by HIPAA and may be purchased by employers to make inappropriate or discriminatory decisions related to hiring, firing, or benefits. The white paper instructs Congress to act to prevent discrimination of consumers based on collection of this identifiable wellness data, often incorrectly assumed by consumers to be protected by HIPAA.

• Patient Notification Upon Removal of Health Data from HIPAA. Senator Cassidy states that software applications authorized through a patient’s right of access to download a patient’s medical record should be required to notify users when transferring health information regulated by HIPAA to an environment where HIPAA no longer applies. Senator Cassidy recommends that these software applications be required to provide plain-language notice regarding their collection and sharing of individuals’ data and seek express consent prior to selling or disclosing patient data to third parties.

• Intake Services. The white paper compares intake information provided in a doctor’s office with similar information provided to a digital health company, noting that the former is covered by HIPAA, but the latter is not. The white paper calls this a “confusing inconsistency” not understood by patients and requests that Congress “provide greater clarity by ensuring HIPAA protections include intake information” to clarify that health data collected virtually receives the same level of protection as in-person treatment.

In this section, Senator Cassidy also acknowledges that the state comprehensive privacy laws do not consistently exempt HIPAA covered entities, which has led to challenges. While Senator Cassidy notes that states have a role in crafting their own regulations, he calls on Congress to consider a “federal floor” for health data in this “gray area,” similar to how HIPAA creates certain minimum requirements but does not preempt the field.

Senator Cassidy also discusses the FTC’s recent efforts to utilize its enforcement framework, including with the proposed updates to FTC’s Health Breach Notification Rule and recent enforcement actions (e.g., against GoodRx and Easy Healthcare). He notes that these efforts create uncertainty by requiring duplicative reporting and compliance with both FTC and OCR requirements. As such, he calls on Congress to consider how best to balance this enforcement framework while continuing to recognize OCR as the “primary enforcement body” over health data.

Data Outside of HIPAA

The third category of proposals centers around data generated outside of the health care setting that still has implications on individual health and privacy, such as geolocation data, internet searches, financial data, and biometric data. Senator Cassidy calls on Congress to pass a comprehensive data privacy law to regulate such data.

For more details on the white paper, see our previous post.