“Don’t look for gods in men; you’ll always be disappointed.” Ladies, can I get an “Amen!”? As much as this theme might apply to real life, this is a line delivered by our wise leading man in Christopher Nolan’s epic action-drama film The Odyssey. I keep hearing about this movie that adapts Homer’s ancient Greek poem to the big screen. But I struggle to see how anyone could condense that classic tale into a mere movie – even if you get Matt Damon, Jon Bernthal, Zendaya, Tom Holland, Anne Hathaway and other A-listers to try to pull it off. Still, the story about a difficult journey and divine interference seems eerily similar to the health policy issue in today’s One Thoughtful Paragraph.
This week’s health tech activity also represents a difficult journey:
- The FDA held a meeting about its proposed recommendations for the Medical Device User Fee Amendments for fiscal years 2028-2032, commitments made in exchange for device developers’ payment of user fees. See meeting agenda here. Comments were due today on the current draft commitment letter that includes relevant digital health proposals, like expanding agency workforce expertise, engaging on emerging technologies like generative and agentic AI, and creating opportunities (e.g., pilots, sandboxes) for device developers to engage with the agency and demonstrate authorization expectations for innovative technologies.
- The HHS Office of the National Coordinator for Health IT (ONC) finalized both updated and new health IT standards as part of the Health IT Certification Criteria for electronic prior authorization in CMS’ FY 2027 Hospital Inpatient Prospective Payment System (IPPS) final rule – which were initially proposed in the CMS Interoperability and Prior Authorization for drugs proposed rule.
- The Sequoia Project’s Interoperability Matters Privacy & Consent Workgroup, which focuses broadly on national privacy laws, granular consent, and data segmentation standards for the entire health care sector – not just TEFCA – released initial guidance for operationalizing automated and computable consent processes, focusing on the specific use case for sensitive substance use disorder information sharing.
“It told you what you most want is what you most can’t have...” This may be what Odysseus (Matt Damon) says about the captivating call of the siren’s song in the movie The Odyssey, but I could have said the same thing about the latest attempt to create new privacy protections for people’s health data. I was a young health care lawyer when the HIPAA privacy rule first came out. About 26 years later, we also have the FTC and about 23 state privacy laws trying to regulate the explosive growth of non-HIPAA health data coming from wearables, apps, patient forums, and the one billion health care queries that Google gets every single day. Enter U.S. Senate HELP Chairman Bill Cassidy, who is having a legacy moment as he prepares to leave his policymaking career: the Health Information Privacy Reform Act was reported out of his committee on August 4, 2026, which would create a brand-new federal regime for “applicable health information” (non-HIPAA-covered data). My problem with its premise — to have HHS and FTC figure out a federal floor — is that it does not preempt state laws; “more stringent” state statutes survive right on top of it. So Washington’s My Health My Data Act, Maryland’s Online Data Privacy Act, and Texas and California’s HIPAA-adjacent statutes, each drafted with their own definitions, consent architecture, and conflicting purposes, create more work for lawyers and compliance officers and increase costs and confusion for everyone. Patients want to know that their health information is being used for good and not evil. There are loads of smart people (see here, here, here) who have been on this privacy odyssey that are trying to address the complexity of our privacy laws, but policymakers must find a way to simplify. Odysseus may well be speaking on behalf of patients when he says: “Why can’t the gods speak in ways we understand?” And Athena says: “Who doesn’t understand thunder? Fire? A child’s smile? A good harvest?”
