21st Century Cures Part 3: Who’s a Health IT Developer?

21^st Century Cures prohibition against information blocking applies to certain actors: healthcare providers, health information networks and health information exchanges, and health IT developers. In this post we’ll take a look at what it means to be a health IT developer and become subjection to the prohibition.

A health IT developer is any developer who has certified a health IT module under the ONC Health IT Certification Program. It does not apply to only what people think of traditionally as electronic health record (“EHR”) developers. Depending on whether a vendor has received ONC certification for any product (or part thereof), the following would likely be captured by the definition:

1. Quality reporting registries
2. Patient portal developers
3. Clinical decision support vendors
4. E-prescription developers
5. Registry vendors

Many other products may be captured as well. Frequently CMS will release a new measure or requirement in one of its physician payment programs that calls for new technology. In many cases, the ONC will create a certification module to support that – and the CMS measure specification will require use of that module. The patient access measures in Promoting Interoperability are a great example: a batch of patient portal developers cropped up in response to the release of those measures. But becoming subject to the information blocking statute should give any developer some pause before pursuing those kinds of opportunities.

The first question I would confront is whether you can accomplish the same means – market growth – without ONC certification. Quality reporting registries are a great example of where the answer very well might be yes. Some certify to the electronic clinical quality measure (“eCQM”) reporting modules under the program. That means they can report eCQM data through an EHR. But why bother? You can report on quality measures as a “qualified registry,” which does not require ONC certification; therefore, it does not subject you to the prohibition against information blocking.

Once you are subject to the prohibition, you are subject to its whole range of compliance burdens. ONC made it abundantly clear that if a developer is not certified under the ONC Health IT Certification Program, it is not subject to the prohibition. However, if even one piece of a developer’s technology is certified, the prohibition applies not only to that technology but also to the developer’s entire commercial technology stack. The prohibition also reaches corporate behavior as a whole. Becoming subject to the prohibition impacts how you license your technology, how you price it, and how you contract with your customers.

So before you decide to obtain ONC certification, think carefully about whether your goals can be achieved by other means. The moment your product receives certification, your other products become similarly regulated, as do your commercial practices. The decision to certify is highly consequential to any new entrant into the healthcare technology market.