RIN Data

The proposed rule would seek to advance interoperability through proposals for standards adoption; the certification of health IT to support expanded uses of application programming interfaces (APIs); and enhancements to the conditions of certification. Additionally, the rule would update the information blocking regulations to support information sharing and improved patient health outcomes. 

Statement of Need:

The Make America Healthy Again initiative, as established by Executive Orders 14212 Establishing the President’s Make America Healthy Again Commission and 14221 Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information, aims to combat chronic disease and enhance price transparency. Executive Order 14267, Reducing Anti-Competitive Regulatory Barriers, further promotes market competition and lowering health care costs. The HTI-6 Proposed Rule is needed to further enhance the access, exchange, and use of electronic health information (EHI) by patients, providers, and third parties - empowering them to address chronic disease, increase market competition, and lower health care costs.  Specifically, proposals in the rule would advance interoperability and EHI sharing through: standards adoption; the certification of health IT to support expanded uses of application programming interfaces (APIs) and potential successor technologies; targeted conditions of certification; and revised information blocking regulations.

Summary of the Legal Basis:

The provisions would be implemented under the authority of the Public Health Service Act, as amended by the HITECH Act and the 21st Century Cures Act.

Alternatives:

ONC will consider different options to improve interoperability and access to electronic health information so that the benefits to providers, patients, and payers are maximized and the economic burden to health IT developers, providers, and other stakeholders is minimized.

Anticipated Costs and Benefits:

The majority of costs for this proposed rule would be incurred by health IT developers in terms of meeting new requirements and continual compliance with the condition and maintenance of certification requirements.  We expect that through implementation and compliance with the regulations, the market (particularly patients, payers, and providers) will benefit greatly from increased interoperability and access to electronic heath information.  We have not yet quantified the costs and benefits of this proposed rule.

Risks:

At this time, ASTP/ONC has not been able to identify any substantial risks that would undermine likely proposals in the proposed rule.