Forecast Cloudy but Clearing: a Crystal Ball for Meaningful Use

Now that the HIT Standards Committee met on September 28^th to wrap up their “Standards Summer Camp” and are well along in several of the ONC Standards and Interoperability Framework initiatives, how do we stand in getting a clear weather forecast for Meaningful Use Stage 2? Activity was fluid during the hot summer, but by the chill of winter, much will have “frozen” into the form of ONC’s Notice of Proposed Rulemaking (NPRM) for Stage 2 Standards and Certification Criteria.

I was pleased to see an initial draft of certification criteria produced by the Implementation Workgroup. While it’s very preliminary, I understood it to be the first cut at the criteria that ONC will refine over the next few months as they write the NRPM, expected to be released for public comment perhaps in January. Here are a few highlights of what I found new or surprising. While my main focus is generally on information exchange criteria, there is some noteworthy new information on other objectives too. Numbers refer to the rows in the document.

• 10 Clinical Decision Support. There’s more specificity around the ability to configure the CDS rules based on user role, patient setting, and points in workflow; also display of the evidence/source of each notification or care suggestion
• 15 Lab Results. Lots of work has been done in the ONC S&I Framework and HL7 on the new Lab Results Interface (LRI) implementation guide, in an effort to bridge the gap between competing standards. I applaud efforts to work together to reach consensus, even if it means no one gets everything they want, so I hope that this standards effort is leveraged.
• 18 Electronic Notes. They provide clarity that it must not be a scanned document, but that pretty much every other kind of electronic note is OK. While functionally that is achievable, hopefully there will be careful consideration in how to measure this objective to avoid burdening providers with workflow issues.
• 23 Patient View and Download. A definite shift to patient-initiation via electronic access (a secure web portal for example) to more information than was required in Stage 1, rather than have to request a copy through provider personnel. There’s still much debate about alternative ways to satisfy this (e.g., is an export to a patient-controlled PHR acceptable?), so it will be important for guidance to be clear here. 
• 29 Exchange Clinical Information. In this objective, as well as Patient View and Download, clarity is needed on how many types of clinical documents are required (one-size-fits-all vs. multiple different documents?). For example, the ONC S&I Framework Transitions of Care initiative has recommended specific documents -- Discharge Summary and Discharge Instructions from a hospital and Consultation Request and a Consultation Summary from an EP, but the MU objective is written as if it is just a single clinical summary.
• 33 Syndromic Surveillance. As expected, there is a new implementation guide, though it is only applicable to hospitals. But there is still uncertainty over considering submission of Reportable Cancer Conditions by EPs. If that is to be included, what is the recommended standard?
• 52 Amendments to information. This is a requirement that had not been included in previous presentations of Stage 2 MU. Will it be in the NPRM? If so, it would include replacing a data element while preserving a record of the previous value, and appending patient-supplied information as free text or scanned image/document, for patient engagement (e.g., if the patient disputes something in the record). Note, they use the word "user" but are not clear whether they mean "patient" for the requirement to "Make electronically available, upon a user's request, a historical account of amendment(s).”
• 53 Patient Matching. This is also something not mentioned in the Policy Committee's MU objectives. It is fuzzy at this point. If included in certification, it would impose more validation upon some demographic data.

I encourage you to read these thoroughly and work through the channels available to you (e.g., a provider association, a trade association, an industry consortium, or comments to ONC’s blog) to submit suggestions for clarification. The people on policy and standards committees work very hard, but it’s impossible for them to anticipate every case where someone might have trouble interpreting. The implementation workgroup already has flagged areas that they know need more work. If you can give examples of how interpretations may vary, and offer constructive suggestions for how it could be worded unambiguously and made testable, I think it will help ONC to write the clearest possible regulatory language.