Legibrief
Mia HeckA newsletter about the regulatory mechanics of U.S. health policy — what policymakers at every level are actually doing, why it matters, and what’s at stake for patients, payers, and industry.
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 17 | Founded | 3 years ago | Last Issue | 21 days ago |
| Active | |||||
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miaheck.substack.comLatest Issues
Healthcare’s Next Security Failure Could Come with Valid Credentials
One of the most damaging attacks on the U.S. healthcare system did not begin with someone picking a lock. It began with someone logging in.
In 2024, the Change Healthcare attackers used compromised credentials to enter a remote-access port...
Not a Rule. Not a Model. A Different Kind of Federal Action
It’s rare to see HHS, CMS, FDA, and ARPA-H leadership on the same stage to launch a research program. That’s what happened on September 30 in Austin, where HHS Secretary Robert F. Kennedy Jr., CMS Administrator Mehmet Oz, FDA Acting Commiss...
Medicare Is Moving Upstream
Two separate shifts have hit FDA breakthrough devices, each moving through its own rulemaking track. One speeds up Medicare coverage decisions. The other makes it more difficult to get paid extra once you’re covered. Medical device develope...
FDA Floats Credentialing AI the Way Doctors Are Credentialed
The FDA is thinking out loud about generative AI. On August 18, the FDA’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence published a discussion paper on how it could eventually regulate generative AI-e...
Elsa and the AI Governance Question at FDA
In June 2025, the FDA deployed the Electronic Language System Assistant, or Elsa—an agency-wide generative AI tool built on a large language model platform—to boost efficiency for personnel ranging from scientific reviewers to field investi...
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Authors
The writers behind this newsletter.
Mia Heck is a Senior Fellow for Healthcare at the Joseph Rainey Center for Public Policy and a Northern Virginia–based consultant.
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