What Congress Hard-Coded
How the statutory definition of a qualified EHR has shaped ASTP’s deregulatory ceiling in HTI-5
Policy is such a balancing act - define things too specifically in law and we are stuck with hard-coded mandates that are difficult to change in a rapidly evolving world. But leave things vague? We end up with a permanent shadow legislature as we struggle to divine what Congress actually wanted.
Earlier this week, I questioned why ASTP did not go further in deregulating certified health IT criteria that were focused on user interface and workflow, rather than data flow:
While the criteria body count is admirable, the ASTP didn’t go as far as I thought they would, quite honestly:
The order entry criteria all seemingly fall into the “ubiquitous capability - mission accomplished” category, as 417 products are certified to one or more. These requirements focus on end-user functionality and workflow behavior rather than data access surfaces. In a rule that repeatedly signals a shift away from certifying what users can do and toward how data is accessed, I’m surprised it was kept.
It turns out they can’t. From 42 U.S. Code § 300jj:
The term “certified EHR technology” means a qualified electronic health record that is certified pursuant to section 300jj–11(c)(5) of this title as meeting standards adopted under section 300jj–14 of this title that are applicable to the type of record involved (as determined by the Secretary, such as an ambulatory electronic health record for office-based physicians or an inpatient hospital electronic health record for hospitals).
Which points to 42 USC § 300jj(13):
(13) Qualified electronic health record The term “qualified electronic health record” means an electronic record of health-related information on an individual that—
(A) includes patient demographic and clinical health information, such as medical history and problem lists;
(B) has the capacity—
(i) to provide clinical decision support;
(ii) to support physician order entry;
(iii) to capture and query information relevant to health care quality; and
(iv) to exchange electronic health information with, and integrate such information from other sources; and
(C) includes, or is capable of including, a real-time benefit tool that conveys patient-specific real-time cost and coverage information with respect to prescription drugs that, with respect to any health information technology certified for electronic prescribing, the technology shall be capable of incorporating the information described in clauses (i) through (iii) of paragraph (2)(B) of section 1395w–104(o) of this title at a time specified by the Secretary but not before the Secretary adopts a standard for such tools as described in paragraph (1) of such section.
These constraints are what is keeping ASTP from fully pulling the plug as they deregulate. Mapping from the qualified EHR definition, we get something like:
