Meaningful Use Stage 2 NPRM means new opportunities for Medical Device and non-traditional Health IT Vendors

Last week at the HIMSS Conference ONC announced Meaningful Use Stage 2 Notice of Proposed Rule-Making. Many of you have asked me for a quick opinion of what it means to health IT and medical device vendors so I wanted to take a few minutes to share my initial thoughts.

Meaningful Use Stage 1 was mostly about setting the bare minimum electronic health record functional requirements and pegging a “floor” for data capture; it had many required elements a few optional elements for care providers to utilize (but vendors had to make even the optional functionality available for use). While vendors had some work to do to get certified, MU Stage 1 criteria was carefully selected to ensure availability of software (which is plentiful now) so it wasn’t too painful for the market in general.

The proposed Stage 2 criteria is primarily focus on increasing structured electronic capture of health information and fostering data exchange at points of care transitions by turning most of the optional items from Stage 1 into required elements so only a few new, mostly evolutionary, requirements have been introduced.

While Stage 1 did take some work on the part of vendors from a software development and certification point of view, MU Stage 2 will be pretty easy for vendors because very little new functionality has been added to the requirements and the new certification requirements will probably allow a “gap certification” capability meaning if you’ve already been certified for certain modules / functions you’ll be able to certify for what’s new and not recertify everything.

Remember, while certain items were optional for care providers to use in Stage 1, vendors had to create the code whether healthcare professionals used those features or not so most vendors with comprehensive EHRs are already in pretty good shape. Since Stage 2 mostly turns some optional data collection for care providers to required data collections, the actual, and much harder, work is on the health professionals and providers and not the vendors. Doctors’ offices and hospitals have more work to do in Stage 2 – namely more data to capture, more of their electronic health record software to utilize.

Existing vendors won’t be affected much; however, the new 2014 certification capabilities will allow more modular, cloud-focused, vendors into the market. In Stage 1 the comprehensive EHR vendors were in the driver’s seat because the purchase and use of an EHR was mandatory for all attestations even if you only attested to parts of MU. Now, however, with the new 2014 certifications coming next year buyers will only need to purchase modules they intent to attest to. This is a big deal and the flexibility afforded by ONC will make the comprehensive EHR vendors more vulnerable than before. In fact, this opens up lots of opportunities for medical device, labs, and digital pathology vendors and they should be looking seriously at MU Stage 2 and 2014 Certification as new market opportunities.

In general, I like the focus on moving to more structured input of health information because structured data promotes reduction of medical errors, analysis of treatments and procedures, and research for new methods. Unfortunately, all the existing MU incentives promote the wrong kinds of collection: unreliable, slow, and error prone.

That’s because MU Stage 1 and 2 force health professionals, patients, and other human users to enter data manually one value at a time instead of getting the data from machines connected to our bodies. Accurate, real-time, data is only available from connected medical devices, digital pathology, labs, biomarkers, and genetic data analysis. Neither Stage 1 nor Stage 2 focus on the right places to get data – for example from medical devices – so the data that will be in our EHRs will remain suspect and not as useful until we get to Stage 3 when there is some hope to get devices, lab systems, biomarkers, and other data into the databases.

What do you think about MU Stage 2 and the new 2014 certification requirements? Drop your comments and questions here and I’ll answer them as best as I can.


Shahid N. Shah

Shahid Shah is an internationally recognized enterprise software guru that specializes in digital health with an emphasis on e-health, EHR/EMR, big data, iOT, data interoperability, med device connectivity, and bioinformatics.