Gathering Feedback on the Certification Rule

john halamka

By John Halamka, MD
Twitter: @jhalamka

Over the next 3 months, the HIT Standards Committee will review every detail of the 431 page Certification rule. We’ll also be holding calls to look at the rule as a whole. At least one call will be open to the general public. Think of this as reviewing the “trees” and the “forest”.

In the meantime, I’m interested in the opinion of the crowd. Feel free to comment on John’s site that provide positive and negative reaction to the rule, just as Micky Tripathi and I divided the initial analysis into the Good, Bad and Ugly.

Important questions to ask:

  1. The ONC Certification rule includes a catalog of many transaction types, only a few of which are related to Meaningful Use. Is it helpful or hurtful to publish everything now in a single large regulation?
  2. Many of the standards included lack maturity per the objective ranking of their adoption. Should regulations include standards that are not yet in use?
  3. The regulation suggests that thousands of developer hours are required for every EHR seeking Stage 3 certification. What effect will such a burden have on the marketplace? How is innovation impacted by the rule as written?
  4. Does certification help interoperability or are there more effective means (economic incentives, culture change, penalties etc)?
  5. The Certification Rule expands the enforcement powers and requirements of the ONC authorized certified bodies, and has sanctions for vendors found not to be compliant with their certification status. Will the prescribed approach be helpful? Related to an earlier question on standards maturity, what is the balance that will need to be struck between tough enforcement and requirements for using immature standards?

Our job, as a country of stakeholders, is to strike the right balance between regulation and market forces. Regulation is sometimes necessary when market failures occur. Over regulation can impede market forces. The Standards Committee and many commenters will help ONC achieve the right balance. ONC has significantly reduced the scope of final rules in the past based on comments. There is hope!

John D. Halamka, MD, MS, is Chief Information Officer of Beth Israel Deaconess Medical Center, Chairman of the New England Healthcare Exchange Network (NEHEN), Co-Chair of the HIT Standards Committee, a full Professor at Harvard Medical School, and a practicing Emergency Physician. This article was originally published in his blog Life as a Healthcare CIO and is reprinted here with permission.