On June 3, 2019, the Physician Clinical Registry Coalition submitted comment letters on proposed rules from the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) related to information blocking and interoperability.

ONC’s proposed rule implements Section 4004 of the 21st Century Cures Act, which prohibits information blocking by health care providers, health IT developers, and health information networks and exchanges.  In its comments, the Coalition urged ONC to address both the ability of electronic health record (EHR) vendors to exchange electronic health information, as well as the usability of the exchanged data.  The Coalition expressed concern about the breadth of ONC’s proposed definitions of health information networks and health information exchanges, as these definitions appeared to be contrary to Congressional intent.   The Coalition strongly urged ONC to ensure that its proposed exceptions to the information blocking prohibition be narrowly tailored.  The Coalition also asked ONC to provide additional information regarding how it will effectively enforce the information blocking provision.  Click here to read the full letter.

CMS’s proposed rule focuses largely on patient access to health care data and interoperability.  In its comments, Coalition urged CMS to take steps to expand provider access to data in order to promote quality of care and enhance health care decision making, as well as to take steps to encourage participation in clinical data registries. Click here to read the full letter.

In both comment letters, the Coalition emphasized that registries and their participants must comply with a complex framework of laws and regulations that includes the HIPAA regulations, the Common Rule, the FTC Act, and state privacy laws and security standards.  The Coalition encouraged ONC and CMS to work with the Office for Civil Rights, the Office of Human Research Protections, and the FTC to eliminate conflicts or duplication between HIPAA, the Common Rule, the FTC’s enforcement efforts, and this new regulatory scheme.  The Coalition looks forward to working with each of these agencies and departments on these important issues.