The final EHR certification criteria for 2014 were released a few weeks ago, and I am surprised by how many of the more forward-thinking proposals made it into the final set. The proposed criteria, released in March, contained suggestions that I thought were good ideas (e.g., usability testing, price transparency, and data portability requirements), but which seemed unlikely to survive the comment period. I was shocked to see they made the cut! Since these criteria affect how products are developed and sold, they may very well change the dynamics of the EHR market by helping some vendors and hastening the demise of others. Their impact on the EHR market could be huge! Let’s take a closer look at the three with greatest potential impact.
This was the biggest surprise. I thought usability testing would become part of certification, but not for the 2014 cycle. According to comments received by the ONC, EHR buyers liked the idea–vendors, not so much. The final criteria contain the following requirement:
Safety-enhanced design. User-centered design processes must be applied to each capability an EHR technology includes that is specified in the following certification criteria: §170.314(a)(1), (2), (6) through (8), and (16) and (b)(3) and (4).
Data for each of the eight 170.314 items (CPOE, medication, and CDS related-features) must be submitted using the NIST IR 7742 template. The following information/sections in NISTIR 7742 are required:
- Name and version of the product
- Date and location of the test
- Test environment
- Description of the intended users
- Total number of participants
- Description of participants: their experience and demographic characteristics
- Description of the user tasks that were tested
- List of the specific metrics captured during the testing for effectiveness, efficiency and satisfaction
- Data scoring
- Results of the test and data analysis
- Major test findings
- Identified area(s) of improvement(s)
Finally, there is this intriguing addition: “This information will become part of the EHR technology’s test report that is required to be made publicly available.” Clearly, the ONC is serious about moving forward with usability testing.
The lack of data portability can be a real pain for EHR buyers (How Long Will You Be Married to Your EHR?). When one considers that switching EHRs can entail reentry of all data, with the possible exception of demographics, it is easy to see how the lack of portability might lead to product lock-in. The ONC noted its concerns about the potential for harm that might occur in the absence of data portability:
We stated that in such a scenario providers should have the ability to easily switch EHR technology –at a low cost –and migrate most or all of their data in structured form to another EHR technology. We noted that in the absence of this capability, providers could be “locked-in” to their current EHR technology, which could ultimately impede innovation. With our belief that data portability is a key aspect of the EHR technology market that requires maturity, we sought public comment on specific questions that could inform our decision on whether to adopt a certification criterion focused on data portability.
The actual certification requirement states:
Data portability. Enable a user to electronically create a set of export summaries for all patients in EHR technology formatted according to the standard adopted at § 170.205(a)(3) that represents the most current clinical information about each patient and includes, at a minimum, the Common MU Data Set and the following data expressed, where applicable, according to the specified standard(s):
(i) Encounter diagnoses. The standard specified in § 170.207(i) or, at a minimum, the version of the standard at § 170.207(a)(3);
(ii) Immunizations. The standard specified in § 170.207(e)(2);
(iii) Cognitive status;
(iv) Functional status; and
(v) Ambulatory setting only. The reason for referral; and referring or transitioning provider’s name and office contact information.
(vi) Inpatient setting only. Discharge instructions.
While these provisions do not provide the ability to move data wholesale from one product to another, they reinforce the fact that captured information belongs to the EHR buyer. It’s a good beginning.
Price transparency, even the little that is actually required, is still a surprise. The IT industry is not known for easy-to-understand pricing. The certification requirement is quite modest; it states:
§ 170.523 (k)(1) (iii) Any additional types of costs that an EP, EH, or CAH would pay to implement the Complete EHR’s or EHR Module’s capabilities in order to attempt to meet meaningful use objectives and measures. EHR technology self-developers are excluded from this requirement.
Vendors must list the types of costs, but not actual prices, associated with products purchased to meet MU. How helpful this information will be to buyers remains to be seen. EHR contracts—all technology contracts—tend to be complex with numerous options and pricing strategies. However, the die has been cast, and it is unlikely that we have seen the last of this as a certification requirement. In addition, while many of those who commented on this proposal were against it, some savvy vendors could well use this as a marketing tool. Price transparency has certainly contributed to the success of CarMax and Progressive.
I have always considered the combination of EHR incentives and MU to be an intriguing experiment in improving care quality using information technology. However, with the addition of usability, data portability, and price requirements to the equation, it is proving to be much more. Not only is the ONC conducting an experiment in healthcare delivery, it is also, through these new certification criteria, challenging the ways HIT is developed and sold.
When publication of certification test results is added to data portability, cost disclosures, and mandatory usability testing, buyers will be better informed and wield greater bargaining power. In one fell swoop, the ONC has begun to reconfigure HIT market dynamics. In 2009, I doubt vendors, charmed by the billions in incentive sugar plums, anticipated so many changes would occur so quickly. Dauntingly, they have only until 2014 to ready their products. Yikes!! Addressing all certification requirements by 2014 will pose a challenge to even the most capable and well-funded companies, and it will be interesting to see who is up to the task. Who knew that ONC was a synonym for meteor?