Yesterday, Meaningful Use Stage 2 was released.
You can read the final rule here and you can read the announcement here.
As we read and parse the 900 or so pages of government-issued goodness, you can expect lots of commentary and discussion. Geek Doctor already has a summary and Motorcycle Guy can be expected to help us all parse the various health IT standards that have been newly blessed. Expect Brian Ahier to also be worth reading over the next couple of days.
I just wanted to highlight one thing about the newly released rules. As suspected, the actual use of the Direct Project will be a requirement. That means certified electronic health record (EHR) systems will have to implement it, and doctors and hospitals will have to exchange data with it. Awesome.
More importantly, this will be the first health IT interoperability standard with teeth. The National Institute of Standards and Technology (NIST) will be setting up an interoperability test server. It will not be enough to say that you support Direct. People will have to prove it. I love it. This has been the problem with Health Level 7 et al for years. No central standard for testing always means an unreliable and weak standard. Make no mistake, this is a critical and important move from the Office of the National Coordinator for Health Information Technology (ONC).
Last week I was invited to attend the second annual NIST forum for EHR Usability called “A Community-Building Workshop: Measuring, Evaluating and Improving the Usability of Electronic Health Records.” NIST, in collaboration with the ONC, unveiled its initial discussion points for what it might consider as the “Usability Criteria” in the upcoming Meaningful Use Stage 2 regulations. At the event I met with Dr. Melanie Rodney, Distinguished Researcher at Macadamian and a member of the HIMSS Usability task force; I was impressed by the work that she and her firm were doing in EHR usability space. At the NIST forum I was able to spend time with experts in the both the fields of EHRs (like me) as well as in usability and user experience (like Melanie). We learned that the government believes that while usability can be key in increasing product effectiveness, speed, enjoyment, etc., NIST is going to focus on EHR usability for the improvement of patient safety. I asked Melanie and Lorraine Chapman, Director of User Research at Macadmian, to share with us what we in the EHR technical community should do in light of what we learned at the NIST forum last week. Here’s what Melanie and Lorraine said:
While the specifics are still forthcoming, vendors have a window of opportunity today to get ahead of NIST – and ahead of competitors – by proactively addressing meaningful use in advance of the 2013 deadline. Let’s look at what vendors can do, combining the information NIST has given so far with fundamental usability best practices:
Step 1: Set Usability Goals related to Patient Safety
These are specific, measurable goals such as “Our EHR must provide a 99% error-free rate of medication entry”. NIST has given the following examples of use error categories, each of which might be driving 1 or more goals.
- patient ID errors
- mode errors [e.g., dose related]
- data accuracy errors
- visibility errors [e.g., tapered dose 80-20mg – 80 shows vs. 20]
- consistency errors [ e.g., pounds vs. kilos ]
- recall errors [e.g., 1 time dose]
- feedback errors [1 tablet vs. 1/4 tablet]
- data integrity errors [ next vs. finish to enter injection just administered]
Meaningful Use has hit a speed bump. It’s of the low, wide and gentle type, not the old raggedy, narrow and mean bump you find in older parking lots. Now that a tentative proposal for Meaningful Use Stage 2 has been published by ONC, and duly commented upon by the public, it just dawned on folks that there isn’t enough lead time between Stage 1 and Stage 2 to allow for an orderly transition, and here is the problem in a nutshell.
Meaningful Use is divided into three, increasingly more demanding, stages, starting in 2011 with Stage 1 and advancing every two years to a higher Stage. So 2013 marks the beginning of Stage2 and 2015 is the start of Stage 3. It seems that ONC and CMS need about a year and a half to define each Stage from start to finish, so if they start working on Stage 2 right after Stage 1 commences, there are only 6 months left for NIST to define certification criteria, EHR vendors to update their wares and certify them, and physician and hospitals to roll the new and improved products out. Oops……
The hand wringing in “industry experts’” circles began immediately after this realization, culminating with an Advisory Board publication advising hospitals in particular to not apply for Meaningful Use incentives in 2011, but instead wait for 2012, which they can do without penalty, and the same advice is applied to ambulatory practices owned by hospitals. They did not recommend anything for physicians in private practice. Continue reading…
In an interesting turn, the Commerce Department’s National Institute for Standards and Technology (NIST) says it is looking to develop standards for evaluating ease-of-use of health IT systems. This raises some questions about the appropriate federal role in guiding the evolution of Electronic Health Records (EHR) systems – should the feds be specifying “usability standards” in the first place?
The NIST notice is currently very preliminary – they are simply looking for companies with expertise in quantifying and measuring Usability in health IT systems. However, the NIST has been charged with developing the specific testing and process documents that will be used (by organizations yet to be selected) to certify EHR systems. The overall policy and specification about Meaningful Use of a Certified EHR, which is needed to access ARRA stimulus moneys available beginning in 2011, have been published for open commentary. However, the specific nuts-and-bolts of certification is being hammered out by the NIST. They have already contracted with Booz Allen Hamilton to help with this process.Continue reading…