UPDATE: Here are the public records for the case. More details there about the original complaint. Excerpt:

What we’re talking about
The purpose of any certification program is to create a method for the purchasers of a product to have confidence that the product safely and reliably does what it is supposed to do. One example from USDA:
Turning Point for Meat Inspection In 1905, author Upton Sinclair published the novel titled The Jungle, taking aim at the poor working conditions in a Chicago meatpacking house. However, it was the filthy conditions, described in nauseating detail—and the threat they posed to meat consumers—that caused a public furor. Sinclair urged President Theodore Roosevelt to require federal inspectors in meat-packing houses.The Pure Food and Drug Act and the Federal Meat Inspection Act (FMIA) became law on the same day in 1906. The Pure Food and Drug Act prevented the manufacture, sale, or transportation of adulterated or misbranded foods, drugs, medicines, and liquors. The FMIA prohibited the sale of adulterated or misbranded meat and meat products for food, and ensured that meat and meat products were slaughtered and processed under sanitary conditions.
In this case, the government moved to protect the public because a subset of meat packers was putting profit above public health. After The Jungle was published, public outcry caused the government to step in and regulate the industry. Regulation is not, therefore, a four letter word. It’s there to protect us from evildoers.
Before Health IT Certification
You may not remember this, but I do. Before there was certification, Health IT development companies (some people call them “vendors”) created software and sold the software with claims of improved provider productivity, improved public health, and (yup) improved billing (among other impressive capabilities). Sometimes these claims were completely valid. Sometimes they were not. In the case where the developers’ functional claims were not quite valid, buyers had little recourse. One might say “well, the markets will take care of that. Bad actors will lose sales.” But that’s not the case here for several reasons:
- The buyer may not be the one using the software. A hospital buys software for clinicians. Clinicians complain to hospital. Hospital may or may not be a strong advocate with developer.
- It’s very hard to migrate from one system to another. EHR purchase / deployment / optimization is a multi-year initiative. If you bought a lemon, you may try to make lemonade as the though of migrating to something else will give you R11.0.
- Shame. You don’t want your patients / competitors / peers to know that your EHR doesn’t work as expected. You made a mistake. Human nature is to hide our mistakes rather than treasure them as educational opportunities.




