On April 11, the Office of the National Coordinator for Health Information (ONC) released its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) proposed regulation, which continues to implement various aspects of the 21st Century Cures Act. The proposed regulation will advance interoperability, improve transparency, and support accessing, exchanging, and using electronic health information. However, the proposed regulation does not address exceptions to information blocking that the American Medical Association (AMA) and CAP advocated for, such as expanding the definition to include psychological harm. The ONC has indicated that they will address these in a separate proposed rule at a later date. The CAP will advocate to ensure that regulations protect patients without overburdening pathologists and laboratories.

The proposed regulation spans the health information technology horizon, including proposals on the movement of health information electronically, on new data standards that help ensure that information can be understood when it enters and leaves a system, on electronic case reporting that supports public health and emergency response across the country, and on algorithm transparency so that health IT users have more information about the algorithms enabled by or interfacing with the certified technology they use for care.

The current proposed regulations that could have implications for laboratory and pathology data include:

• Information blocking and patient access to health information: The ONC continues to seek to increase patient access to information, including a proposed provision to provide patients access to predictive DSI (Decision Support Interventions) – underlying data used to generate recommendations. If a patient requests access to their information held by a health care provider, the information required to be sent could include, for example, the underlying data used to generate recommendations about their health care.
• Interoperable data to support public health/emergency response: The proposed regulation talks about the need to increase data sharing for public health and emergency response; this would mean interoperable data sets including laboratory data.
• Laboratory interoperability: In addition to proposing new standards to support public health initiatives, the proposed regulation seeks input to strengthen and advance laboratory interoperability.
• Algorithm transparency: The proposed regulation calls for algorithm transparency to reduce the potential for “algorithmic discrimination.”

The CAP will review the proposed regulation and submit its comments by June 20.