- Stakeholders including Health IT Now, AAFP, and AMIA are disappointed that ONC has not published clear information blocking regulations per provisions of the 21st Century Cures Act (Cures) almost two years after the piece of legislation was enacted in December 2016.
In a recent letter to National Coordinator for Health Information Technology Donald Rucker, MD, and HHS Inspector General Daniel Levinson, stakeholders pressed federal entities about the lack of progress toward penalizing health IT companies for inhibiting the flow of patient health data between EHR systems and healthcare organizations.
“One year ago, Health IT Now convened a diverse group of stakeholders to discuss and make recommendations on regulations to implement the information blocking provisions of the 21st Century Cures Act, which was enacted in December 2016,” wrote stakeholders in the letter.
“Our diverse group came together because we believe information blocking poses a significant risk to patient safety and greatly contributes to increased costs and waste in the health care system,” stakeholders continued.
Provisions in Cures mandate the creation of information blocking regulations that identify which activities are acceptable for health IT companies.
“Section 4004 of 21st Century Cures requires the Secretary of Health and Human Services to issue regulations to prevent information blocking and to also identify reasonable and necessary activities that do not constitute information blocking,” explained stakeholders.
“Further, the law requires the Office of the National Coordinator (ONC) to implement a standardized process for the public to submit reports on claims of health information technology products or developers of such products not being interoperable or resulting in information blocking and actions that result in information blocking,” they continued.
OIG is authorized to penalize vendors or providers who engage in information blocking. ONC stated its intention to develop and publish a definition of information blocking as part of a new proposed rule that will update the ONC Health IT Certification Program.
However, this definition is not due for release until September.
“It has been 601 days since the 21st Century Cures Act was signed into law,” wrote stakeholders. “Every day that the administration delays implementation of these critical provisions places patients at risk of harm. Information blocking impedes provider access to the most current, accurate, or complete information on their patients.”
Stakeholders argued that the lack of clear information blocking regulations muddles ONC’s efforts to promote interoperability and open application programming interface (API) use and development.
“As the administration proposes and implements new rules related to open APIs and interoperability in Medicare’s payment rules for hospitals and doctors, the lack of clear rules of the road needlessly creates uncertainty for vendors and providers alike,” maintained stakeholders.
Further delay in releasing information blocking rules runs counter to ONC’s mission to accelerate health IT innovation and health data exchange.
“The administration has had 601 days to draft and publish clear information blocking regulations,” stakeholders concluded. “We understand the nuance required but feel that it is past time for a proposal to be made.”
In addition to AAFP, AMIA, and Health IT Now, the American Academy of Ophthalmology, the Brain Injury Association of America, Oracle, National MS Society, United Spinal Association, and others supported the push to spur action toward developing information blocking rules.
Forthcoming information blocking regulations due out in September will support the Trusted Exchange Framework and Common Agreement (TEFCA.)
TEFCA is intended to promote the creation of a network of networks to enable true interoperability across healthcare.
While the framework is voluntary, accompanying information blocking regulations will be applicable to the entire industry.