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The rulemaking would implement certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric healthcare providers and reasonable and necessary activities that do not constitute information blocking. The rulemaking would also modify the 2015 Edition health IT certification criteria and Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.

Statement of Need:

In part, title IV of the 21st Century Cures Act requires the Secretary to engage in notice and comment rulemaking that would help advance interoperability and the exchange of health information, including by addressing informationblocking.The interoperability of health information is central to the efforts of the Department of Health and Human Services to enhance and protect the health and well-being of all Americans.

Summary of the Legal Basis:

The provision 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 considered 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 rule will be incurred by health IT developers in terms of meeting new requirements and continual compliance with the regulations. We expect, however, that through implementation and compliance with the regulations the market particularly providers, patients, and payers will benefit greatly from increased interoperability and access to electronic heath information (e.g., the need for less interfaces or making health information more accessible at lower costs). Other proposed changes are aimed at relieving some administrative burdens for health IT developers. 

Risks:

At this time, ONC has not been able to identify any substantial risks that would undermine the implementation of the final rule. ONC will continue to monitor any potential risks and will continue outreach with stakeholders to swiftly address any issues that may result from the final rule.