REGULATORY REVIEW


rule suggests a much broader range of authority. At the time of publication, ASCA is seeking clarification from ONC on ASCs’ exposure to regula- tion under the rule and will formulate comments that seek the least burden for ASC compliance accordingly. As promised, ONC delineates


seven circumstances which, if occur- ring, would not constitute informa- tion blocking.


are more categorical


The circumstances than


specific,


as ONC sought to provide a compre- hensive response to industry concern regarding information blocking while also accounting for “legitimate practi- cal challenges” that actors might face in individual cases. The seven excep- tions are: 1. Preventing harm 2. Promoting the privacy of EHI 3. Promoting the security of EHI


4. Recovering costs reasonably incurred


5. Responding to requests that are infeasible


6. Licensing of interoperability elements on reasonable and non- discriminatory terms


7. Maintaining and improving health IT performance


Although the information blocking proposal was the most anticipated and the longest section of the rule, ONC asserts a few other proposals as well. ONC proposes a new approach for ini- tial and ongoing certification for health IT developers and their certified prod- ucts. This is essentially a matched regu- latory structure: developers must adhere to seven conditions—such as not infor- mation blocking, publishing application programming interfaces, and undergo- ing real world testing—to participate


in the Health IT Certification Program. These are initial requirements, and for each of the seven conditions, there are separate Maintenance of Certification Requirements that demonstrate ongo- ing compliance. If a developer or plat- form is found to be in violation of the initial conditions or maintenance condi- tions, their participation in the program may be terminated.


The rule also includes changes to the 2015 Edition Certification Cri- teria and the Health IT Certification Program overall. The Common Clini- cal Data Set (CCDS), the standard for common clinical vocabulary in HIT, is being replaced by a new US Core Data for Interoperability (USCDI) Stan- dard. The electronic prescribing and clinical quality measures criteria are being updated to align with CMS stan- dards and two new certification crite-


32 ASC FOCUS JUNE/JULY 2019 | ascfocus.org


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