What really is a Health Information Exchange?

Seems like it should be a simple question. The Cures Act has a definition and ASTP wrote a regulation. There's a whole regulatory framework in informatioon blocking foundationally built on the assumption that we know what an HIE/HIN is.

After reading the 143-page transcript from the Vyne Dental® v. Henry Schein One oral arguments and stress-testing the definition against both sides' positions, I'm not sure it describes any entity that actually exists.

1. The bilateral exchange carveout excludes federated networks - every transaction in Carequality, DirectTrust, and TEFCA decomposes into bilateral pairs.

2. Henry Schein's argument excludes centralized repositories. And if that's right, most state HIEs are out too.

3. The governance discretion requirement potentially excludes QHINs and other on-ramps operating under someone else's business rules.

Look hard at it and you see three overlapping exclusion zones cover nearly the entire landscape of health information exchange as it actually operates in the United States. The surviving white space is a sliver (and probably not what our government intended).

Vyne's lawyers had a bad day in court (and HS1 made some blunders too), and I go through the strategic errors in detail. But the deeper problem isn't the lawyering... it's that the definition at the foundation. And the neither of the outcomes we're headed to seem right. Henry Schein is winning, but the logical endpoint of their argument would gut the information blocking framework entirely. Vyne's reading, if it ever gets traction, sweeps in every entity with a database and an API. And there's really no middle ground without heading back to Congress.