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.

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

  1. Sriram Hariharan


    Thank you for giving this crisp insight on the MU Stage 2 requirements enforced by the ONC. It is clear that this is oriented more towards the healthcare professionals than the vendors as in the case of Stage 1. It would get more interesting when Stage 3 comes into action as we can get the EHR systems to get real-time data  from medical devices which that are more structured in form and less error-prone!

  2. Nice succinct overview.  While interfacing medical devices would increase data capture, this approach leaves out a whole universe of patient data.  For example, looking at some measures such as CAUTI, foleys aren’t interfaced yet.  I would bet they won’t be anytime soon.  This is an observation that a provider must make and document.  Combinging that with an interfaced result of a urine culture would certainly help id a patient with a potential CAUTI.  There is an entire universe of observations that provide a picture of a patient that needs attention.  Whether it be an increase of NLP parsing into SNOMED concepts or creating better structured documentation, this is a rich area for improvment.

    1. Great points, N4matishun and I agree with all of them. You’re absolutely right that foleys need to be integrated into EHRs as well (I just lump them with “medical devices”).

  3. Moving most all primary care and specialty MDs to EHR systems is still premature
    because of the almost complete lack of any standards for exchange.  Almost all systems are design for use with themselves and not others.  And our health system in this country only talks about ACO approaches, but does not undertake the politics of converting to a Federal Government run operation.  If it continues as is
    the “for profit” aspect of medical practice in the USA makes patients allowing there
    data to be in them a BIG mistake.  

    Why would YOU allow  the federal government or any “system” to know your or
    your families medical risks.  The cancer in the family and god forbid the 
    Huntington’s disease family history needs to be a carefully guarded secret in the 
    US health system.  That is until you can qualify for Medicare or Medicaid or SSI

    I see NO simple solution, but I wish the EHR incentivisors would address this

    Chris Bickford MD FACPM
    La Jolla CA

  4. Amazing ideas – Apropos , if anyone has been needing to merge two PDF files , my boss came across announcement here

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