Two recent actions by lawmakers are intended to address certain uses of technology in health. First, two Senators have introduced a bipartisan bill related to the collection and use of identifiable health data from wearable health trackers.  Second, following an appeal from Democratic lawmakers, the Agency for Healthcare Research and Quality (“AHRQ”) plans to review the use of race-based algorithms in medical care.

SMARTWATCH Data Act.  On February 25, 2021, Senators Bill Cassidy (R-La.) and Jacky Rosen (D-Nev.) introduced the Stop Marketing And Revealing the Wearables And Trackers Consumer Health Data Act (the “SMARTWATCH Data Act”).  The bill would place certain limitations on the transferring, selling, and sharing of consumer health information derived from certain health devices.

  • Consumer health information: The bill’s key provisions would apply to information about the health status, personal biometric information, or personal kinesthetic information about a specific individual that is created or collected by a personal consumer device, whether manually or through sensors. “Personal consumer devices” is defined as any “equipment, application software, or mechanism” (including regulated medical devices) whose primary purpose or capability is to collect or transmit consumer health information.
  • Domestic Prohibitions: The bill’s restriction on the sharing of consumer health information would vary based on whether the recipient is subject to the jurisdiction of the United States.  The domestic sharing of consumer health information would be restricted only where the recipient is an information broker or the sharing is for certain “commercial” purposes.   Even in such cases, such sharing would be permissible pursuant to a number of potentially relevant exceptions, including with the consent of the applicable individual, where consumer health information is shared with a third-party service provider subject to appropriate confidentiality and security terms, or sharing with a “covered entity” for HIPAA purposes (such as most health care providers and health plans).  The bill also includes a research exemption where the recipient is acting in the public interest for the purpose of conducting scientific research.
  • Foreign Prohibitions. The bill would prohibit any sharing of consumer health information with an entity outside the jurisdiction of the U.S. no matter the purpose.  There is a single more limited exception that requires a number of conditions be satisfied, including that the transferring entity determine that the recipient will afford the same level of privacy protection and that the sharing is only for limited and specific purposes consistent with consent provided by the individual.
  • HIPAA Amendments: The bill provides that any covered entity or business associate that receives consumer health information created from a covered device must protect this information in compliance with HIPAA regulations.
  • Enforcement: The Department of Health and Human Services would have enforcement responsibilities.

In a public statement, Senator Cassidy said the bill’s purpose is to stop “big tech from collecting or selling data without the user’s consent.”  The Senators proposed this bill last Congress, but it died after referral to the Senate HELP committee.

Review the use of race-based algorithms.  Back in September 2020, Senators Elizabeth Warren (D-MA), Ron Wyden (D-OR), Cory Booker (D-NJ), and Congresswoman Barbara Lee (D-CA) requested that AHRQ review the use of clinical algorithms in medical practice that include a patient’s race among its inputs.  The request letter cited examples of reported instances in which race impacted the care black patients may have received.  Referencing the request from the Democratic lawmakers, AHRQ has announced a review of the use of such algorithms and has requested information on the topic to aid its efforts.  The request for information is open until April 16, 2021.  AHRQ is requesting evidence on whether any clinical algorithms introduce bias into clinical decision making.  For example, AHRQ is asking for any information on the extent to which health care providers are aware that algorithms they use include “race/ethnicity or other variables that could introduce bias in these algorithms and the implications for clinical decision making.”  The Democratic lawmakers who wrote to AHRQ suggested that this inquiry could help “ensure that medicine and public health organizations take an anti-racist approach to medical care.”

We will continue to monitor the SMARTWATCH bill and any results from AHRQ’s inquiry.

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Photo of Libbie Canter Libbie Canter

Libbie Canter represents a wide variety of multinational companies on privacy, cyber security, and technology transaction issues, including helping clients with their most complex privacy challenges and the development of governance frameworks and processes to comply with global privacy laws. She routinely supports…

Libbie Canter represents a wide variety of multinational companies on privacy, cyber security, and technology transaction issues, including helping clients with their most complex privacy challenges and the development of governance frameworks and processes to comply with global privacy laws. She routinely supports clients on their efforts to launch new products and services involving emerging technologies, and she has assisted dozens of clients with their efforts to prepare for and comply with federal and state privacy laws, including the California Consumer Privacy Act and California Privacy Rights Act.

Libbie represents clients across industries, but she also has deep expertise in advising clients in highly-regulated sectors, including financial services and digital health companies. She counsels these companies — and their technology and advertising partners — on how to address legacy regulatory issues and the cutting edge issues that have emerged with industry innovations and data collaborations.

Photo of Anna D. Kraus Anna D. Kraus

Anna Durand Kraus has a multi-disciplinary practice advising clients on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (HHS) gives her broad experience…

Anna Durand Kraus has a multi-disciplinary practice advising clients on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (HHS) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and health information privacy. Ms. Kraus regularly advises clients on Medicare reimbursement matters, the Medicaid Drug Rebate program, health information privacy issues (including under HIPAA and the HITECH Act), and the challenges and opportunities presented by the Affordable Care Act.