Good News for Innovation in Healthcare IT . . . and Some Predictions and Cautions

Mark Segal

In prior blog posts I have argued for more flexible health IT regulation (HIT), especially for the EHR incentive program – meaningful use. Recognition of the need for a more focused, innovation-oriented approach has been gathering steam over the past few months, notably from the federal government but also from other stakeholders.

Earlier this year, the Health IT (HIT) Policy Committee and its Meaningful Use Workgroup adopted an approach to Stage 3 of meaningful use that is more constrained than prior proposals. Following adoption of its recommendations, the Meaningful Use Workgroup on May 20 and 27 (GE Healthcare IT General Manager of Clinical Business Solutions Jon Zimmerman testified on the 27th)) provided what Workgroup chair Paul Tang, MD described as a “consistent” message of the need for more focus in Stage 3 and more realistic timing, including using payment and delivery reform to drive demand for interoperability rather than federal regulations. In addition, in May, based on vivid stakeholder input, the Policy Committee’s Certification and Adoption Workgroup proposed a much more targeted approach to EHR certification, which was largely adopted by the Policy Committee.

Meanwhile, Karen DeSalvo, MD, head of the Office of the National Coordinator for Health IT (ONC), who took office in December 2013, has reorganized ONC to reflect new budget and environmental priorities. Dr. DeSalvo and key ONC staff have been emphasizing innovation and a less prescriptive approach to HIT oversight, quality measurement and certification.  At the same time, CMS has announced in multiple public forums that Stage 3 will be the last formal “stage” of meaningful use, again citing budget and program priorities. Most recently, CMS, recognizing that Stage 2 and implementation of the “2014” edition of certified EHR technology (CEHRT) has had a slow start, has expanded “hardship exceptions” for penalties for non-meaningful use this year to include challenges related to availability of certified EHRs and in May issued a fast track Proposed Rule to give hospitals and eligible professionals more flexibility on which edition of CEHRT and which stage of meaningful use to use in 2014. Comments are due July 21 and CMS is pushing for a Final Rule by the end of August.

There has also been recent congressional focus on the need for meaningful use and other HIT regulation to provide flexibility and encourage innovation.  Meanwhile, three agencies—ONC, the Food and Drug Administration (FDA), and the Federal Communications Commission (FCC) —recently issued a draft report, per a congressional mandate in theFDASIA legislation, on a risk-based approach to HIT oversight and regulation. This brief but information-packed report, with public comments due July 7, accepted calls by the Bipartisan Policy Center (BPC) and other stakeholders for a new risk-based approach to HIT oversight that would have the FDA only regulate highest risk HIT.Explicitly following on this report, FDA in late June issued a draft guidanceto reduce or eliminate active regulation of three types of HIT – medical device data systems, medical image storage devices and medical image communications devices.

These developments reflect a welcome sense that policymakers are increasingly focused on encouraging innovation in HIT and in learning from the experiences of various federal programs, including meaningful use. So, some final thoughts and suggestions.

First, meaningful use is not going away. It was established by Congress and has been achieving its principal goal of driving what have become very high levels of hospital and eligible professional adoption of EHRs and other HIT, exceeding 75%. At the same time, we are likely to see more focused scope for the program that will make it less prescriptive and intrusive while maintaining its focus on driving interoperable EHR and HIT adoption.  Such adoption and use is central to many government and private sector initiatives around value-based payment and delivery and payment reform. Moving forward, HIT policy will emphasize:

  • Broader and deeper standards-based interoperability, including existing query-based standards and emerging, API-focused standards –interoperability will increasingly emphasize access to EHR data to support “big data”, analytics, research, and registries
  • Expanded emphasis on “modular” HIT design
  • EHR/HIT-enabled quality measurement, increasingly central to federal, state, and private sector payment and delivery programs, with an emphasis on outcomes
  • Clinical decision support, linked to quality measures to create a virtuous cycle
  • Usability and patient safety, including external reporting through Patient Safety Organizations (PSOs) and similar organizations of patient safety events –FDA, ONC and FCCwork following up on their FDASIA report will be an important driver
  • A continued focus on “patient” engagement, including patients’ access to EHR data and ability to submit their data into EHRs and other HIT
  • The need to enable providers to succeed in current and emerging new payment and delivery models, such as integrated care, ACOs, bundling, and patient centered medical homes

Moving beyond a primary policy focus on EHRs and meaningful use, and increasing regulatory flexibility as well as responsiveness to actual experience, make sense. At the same time, all parties, including ONC and CMS (especially), providers, and vendors need to continue to devote needed resources to support implementation of Stage 2 of meaningful use and the associated 2014 certified EHR edition (and any follow-on meaningful use stages and editions).

In addition, although flexibility and responsiveness are positive, we must recognize that providers and vendors are making very costly decisions based on current rules and requirements. Mid-course changes to those requirements can lead to wasted efforts and possibly compromise overall program prospects for success. They may also reduce stakeholder confidence that regulatory requirements will actually be implemented and therefore should be factored into planning.  At the end of the day, some “messiness” is inevitable but at a minimum, policymakers need to learn from experiences with such programs as meaningful use and ICD-10 so the need for future, unplanned , mid-course corrections is minimized.


One thought on “Good News for Innovation in Healthcare IT . . . and Some Predictions and Cautions

  1. Mark, this is a nice summative piece on the state of play in HIT policy development. Thanks for posting. Do you have any thoughts about areas for future research? Any role for NLM?

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