2023-05-24 - Meeting Agenda

Chair:  @Bryn

Scribe: @Isaac 

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Attendees

Minutes Approved as Presented 

Agenda Topics

Supporting Documents

Updated comments from 5/24/2023 CDS/CQI discussion:

With regard to the CDS Hooks RFI at https://www.federalregister.gov/d/2023-07229/p-1488:

(RFI language for reference):

Given the growing use of CDS and potential for CDS to improve clinical decision-making, we request comment on the scope and maturity of the FHIR CDS Hooks specification v1.0, which we are considering for future inclusion as part of the Program. Recognizing that CDS Hooks does not prescribe a default or required set of hooks for implementers, we further request comment on specific hooks that we might include in future certification criteria (the CDS Hooks specification, for example, defines a small set of hooks), as well as input on use of CDS Hooks for supporting workflow improvement and reducing health care provider burden. To the extent commenters have specific CDS Hook use cases for supporting the latter, we welcome input on this including comment on the readiness and feasibility of such use cases including, as an example, for the screening and assessing of social risk and health related social needs or history.

• The CDS Hooks STU2 specification is published and is the most relevant version (https://cds-hooks.hl7.org/2.0/). We recommend that, until a more recent normative specification is published, this be the version that is referenced in guidance. As newer versions become available, we recommend that the ONC consider updating the version of the specification to reference. The HL7 Clinical Decision Support Work Group would be happy to provide feedback on what version of the specification may be most appropriate to reference at any given point in time.
• A fully normative specification for CDS Hooks is currently planned for ballot in the next 6 months to a year, including a normative specification for CDS Hooks hooks.  When these fully normative specifications become available, we recommend these versions be referenced in guidance.
• There are a number of implementations and successful projects using CDS Hooks. EHR vendors that support the standard currently include, to our knowledge, Epic, Allscripts, and CorroHealth T System. There are also additional EHR vendors actively working on supporting the standard, including Oracle, Cerner, NextGen, and eClinicalWorks. In addition, there are also a number of CDS vendors supporting this standard, as well as planned key functionality such as electronic prior authorization using this standard. We believe these uses all indicate sufficient maturity of the standard to be included in guidance. 

With regard to the proposed guidance to include various detailed metadata on predictive and evidence-based decision support interventions (DSIs), we applaud ONC for prioritizing equity in health care, including through encouraging transparency on how DSIs could inadvertently exacerbate health and societal disparities. However, as proposed, these regulations create significant implementation burden with unclear benefits. These regulations may also paradoxically increase disparities by reducing innovation and the implementation of DSIs due to increased regulatory burden. We therefore recommend the following:

• Prior to mandating a national regulation in this area, fund and conduct rigorous studies to evaluate the impact of the proposed regulations when implemented, as well as the implementation burden imposed on stakeholders including health IT vendors and clinical practices. To our knowledge, there have been no rigorous studies evaluating whether the proposed approach leads to any actual improvement in care. Even just for providing a simple literature reference for a DSI, the only directly relevant randomized controlled trial we are aware of is the study conducted by Dr. Clem McDonald over 40 years ago (McDonald CJ et al. Physician Response to Computer Reminders. JAMA. 1980;244(14):1579-1581. doi:10.1001/jama.1980.03310140037026). This study directly evaluated the impact of computer-generated DSI reminders with and without the provision of bibliographic citations and did not find a statistically significant difference in clinician response to the reminders. 
• In order to reduce implementation burden, and to avoid a potentially massive duplication of effort across health IT vendors and clinical providers, we recommend that the ONC or other suitable federal agency maintain the recommended metadata on behalf of the US public for any DSIs whose underlying information/knowledge are available in the public domain (e.g., the ASCVD predictive DSIs cited in the proposed regulations). For example, the ONC could maintain a Web site for DSI meta-data that health IT systems and implementers from health systems could easily link to, which are updated once on behalf of the entire community. This would also allow patients and clinical users who are not using EHR systems (e.g., Web-based calculators) to easily find relevant information about these DSIs. If the ONC or the federal government wishes to avoid the implication of endorsing particular DSIs, we recommend that the ONC fund a non-governmental organization to maintain this information on behalf of the public. 
• To avoid ambiguity on what is required and what is not, we recommend that the ONC start by requiring linkage to this information only for those DSIs centrally supported by a government-sponsored resource as above, or when using DSIs that have been classified and regulated as a medical device by the FDA.
• While the proposed regulations would allow compliance by noting not the specified metadata, but a note that the metadata are not available, we do not believe this is a harmless addition. Providers are already beset with alert fatigue, and adding yet more irrelevant information (e.g., alerts that more often than not have links to information that, when clicked, simply notes that ONC-required metadata are not available) is likely to contribute to further provider burnout, dissatisfaction, and alert fatigue. It is even possible, and potentially probable, that such an approach would lead to patient harm by increasing the likelihood that providers ignore relevant alerts, including alerts critical for ensuring patient safety, due to an increase in alert fatigue. We therefore recommend that, if the information is not available, that the proposed regulations allow providing no information or additional links, rather than a link noting that information is not available.

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