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The Federal Trade Commission staff has submitted a comment to the Department of Health & Human Services’ Office of the National Coordinator for Health Information Technology, or ONC, regarding ONC’s proposed rule on “information blocking.”

Recognizing that Congress sought to foster greater interoperability between electronic health records systems and the productive flow of electronic health information under the recently enacted 21st Century Cures Act, the FTC staff comment suggests that ONC consider changes to ensure the final rule does not inadvertently distort competition or impede innovation, to the detriment of consumer welfare.

The comment includes four suggestions for potential adjustments to the proposed rule, including ONC’s proposed exceptions for “reasonable and necessary activities that do not constitute information blocking for purposes [of the proposed prohibition].”

The comment asks ONC to consider:

  • using other, more fully developed examples of permissible conduct in order to clarify genuine safe harbors for conduct that does not harm competition or consumer welfare;
  • adjusting the definition of Electronic Health Information so that it applies more narrowly to the information central to purposes of the authorizing statute, such as information needed for patient treatment and Health Information System interoperability;
  • clarifying when market pricing is not deemed information blocking, and providing additional leeway for market pricing and certain ordinary refusals (or failures) to deal under the “recovering costs reasonably incurred,” “responding to requests that are infeasible,” and the “licensing of interoperability elements on fair and reasonable terms” exceptions; and
  • narrowing the proposed definition of “developers of certified Health Information Technology” to focus on those activities or practices that involve certified Health Information Technology.

The Commission vote approving the comment to the ONC was 3-0-2, with Commissioners Rohit Chopra and Rebecca Kelly Slaughter abstaining. (FTC File No. V190002; the staff contact is Daniel Gilman, Office of Policy Planning, 202-326-3273.)

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Contact Information

Betsy Lordan
Office of Public Affairs