
Excerpts from the article by Jeffrey A. Singer and Patrick G. Eddington :
In March, the Department of Health and Human Services (HHS) announced that the Advanced Research Projects Agency for Health (ARPA-H) would begin investing in new biowearable technologies through a program it called Delphi, after the ancient Greek sanctuary where the maxim "know thyself" was inscribed. It's a fitting name for a program designed to help people understand their bodies, but it also raises an uncomfortable question: Who else might come to know them just as well?
The program aims to develop biosensors capable of continuously monitoring cytokines (cellular inflammation markers) and hormone levels, going substantially beyond what current wearables can detect. Funding will be determined on a competitive basis as private-sector stakeholders submit proposals; no specific appropriation has been announced.
It remains unclear why taxpayer funding is necessary in a field that is already thriving.
Consumer biowearables fall almost entirely outside the two legal frameworks most people assume protect their health data. Many do not fall within the Food and Drug Administration (FDA) medical-device regulatory framework, and the Health Insurance Portability and Accountability Act (HIPAA) does not cover health data unless they are generated within a doctor-patient relationship. That means the intimate physiological data streaming off your wrist every five minutes are often legally available to data brokers, insurers, employers, and law enforcement. Law enforcement agencies in the United States and other jurisdictions have already purchased commercial data, including from wearables, to conduct location tracking.
Congress has made incremental attempts to address the HIPAA gap. The bipartisan Smartwatch Data Act — introduced by Sens. Jacky Rosen (D–Nev.) and Bill Cassidy (R–La.) — would require consumer consent before wearable health data can be sold or shared. Cassidy has separately introduced the Health Information Privacy Reform Act, which would extend HIPAA-like protections to wearable data. Neither has advanced. Meanwhile, some states have enacted partial protections: Illinois' Biometric Information Privacy Act and California's Consumer Privacy Act offer meaningful but incomplete coverage.
The legislative gap is not just technical. It reflects a political failure to confront the reality that the ability to monitor a person's physiology continuously, in real time, is now embedded in millions of consumer devices, increasingly tied to federal funding and procurement, and available to government agencies that purchase the information from middlemen or directly from the gadget manufacturers if their terms of service say they may sell the data.
Biowearables can empower individuals. Used voluntarily, with strong privacy protections and meaningful consent, they could expand personal health autonomy. But a government that funds the technology, promotes putting it on every American's wrist, and builds its own procurement pipeline for the same tools isn't empowering patients. It's laying the groundwork for the most intimate surveillance infrastructure ever created, one heartbeat at a time.
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