“Just try to keep your balance so you don’t jar this thing,” Mac said. That’s a quote from the main character in Eruption, giving instructions to a guy stuck in a helicopter that crashed into a volcano. It is not a surprising scenario given that it is a scene from the new Michael Crichton book. Crichton is a Harvard medical school-trained author of multiple books including Jurassic Park, and many screenplays including The Great Train Robbery — which starred Donald Sutherland who sadly passed away yesterday. What is odd about Michael Crichton having a “new” book is that he died in 2008. But his widow asked James Patterson (famous for his formulaic but bestselling novels, including collaborations with Bill Clinton and Dolly Parton) to finish the manuscript Crichton was working on. In the One Thoughtful Paragraph below, we discuss another resurgence of an old manuscript with new life, but this one involves health policy.
Other oldie-but-goodies in the news this week:
- The FDA released an updated document that first came out in 2021 – guiding principles for the “Transparency for Machine Learning-Enabled Medical Devices.” It describes what good machine learning practices look like when supporting the development of medical devices and improving their performance.
- The DEA finally did a re-write of its not-well-received proposed rule that explains who can prescribe controlled substances via telehealth. There are telehealth companies that allow doctors to prescribe things like Adderall for ADHD and buprenorphine for opioid use disorder. They have all been waiting for the DEA to say something for months since its first attempt at a regulation, which received about 38,000 unfriendly comments.
- CMS published updated FAQs for the Hospital Price Transparency rule, which clarifies the new requirements to comply with by July 1, 2024.
History has a way of repeating itself. That’s why we are only a few short weeks away from the new Twister movie coming out – a sequel to the 1996 film (screenplay written by Michael Crichton) that had a young Philip Seymour Hoffman hilariously explaining a tornado’s “Suck Zone.” We wish health information policy were this entertaining, but the best we’ve got right now is a rumor that a bunch of members of Congress are about to hold a full committee markup of the latest version of a national privacy law (the American Privacy Rights Act of 2024). The idea is to create strong data privacy and security standards that reduce the ability of sensitive data to be hacked or stolen, eliminate the confusing patchwork of state privacy laws, and give people the right to sue when their privacy rights are violated. We’ve seen this movie before and hope the sequel is more successful than the original. What’s interesting to us is that two of the country’s health privacy policy experts just crafted a number of recommendations about how to create trust in a system that allows electronic health data to flow freely – and those recommendations look nothing like the law that Congress is about to consider. In short, our nation’s health data privacy policy is like the “Suck Zone” – the point at which the tornado sucks you up and you just swirl in it and never come back down. Or maybe it just sucks.
