FTC Staff Letter to Department of Health and Human Services Concerning the 21st Century Cures Act: Interoperability, Information Blocking and the ONC Health IT Certification Program Rule

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UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
WASHINGTON, D.C. 20580
Office of Policy Planning
Bureau of Economics
Bureau of Competition
Bureau of Consumer Protection
RIN 0955–AA01
Department of Health & Human Services
Office of the National Coordinator for Health Information Technology
Attention: 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health
IT Certification Program Final Rule
The staff of the Federal Trade Commission Office of Policy Planning, Bureau of
Economics, Bureau of Competition, and Bureau of Consumer Protection (“FTC staff”)1 write to
express our appreciation to the Office of the National Coordinator for Health Information
Technology and the Department of Health and Human Services for their consideration of FTC
staff’s comments on the 21st Century Cures Act: Interoperability, Information Blocking, and the
ONC Health IT Certification Program Proposed Rule. We write to offer our perspective on
certain changes in the Final Rule2 to provisions of the information blocking regulations upon
which FTC staff commented previously.3 We believe that several of those changes are salutary
and will likely further ONC and FTC’s joint goals of fostering procompetitive innovation in
health IT while protecting patient privacy.
First, the definition of electronic health information (“EHI”) has been streamlined in the
Final Rule so that it applies more narrowly to information of concern to the relevant provisions
of the authorizing statute. Second, as a related matter, the Final Rule’s new “content and
manner” exception should facilitate near-term compliance with the Rule’s requirements
regarding EHI. Third, the Final Rule clarifies and streamlines the concepts of “exchange, access,
and use.” We appreciate ONC’s thoughtful responses to FTC staff’s comments on these issues.
FTC staff also appreciates ONC’s clarification that the Final Interoperability Rule does
not alter the FTC’s role in protecting the privacy and security of consumers’ personal
1 These comments reflect the views of FTC staff. They do not necessarily represent the views of the FTC or of any
Commissioner; the Commission has, however, voted to authorize staff to submit these comments.
2 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program (to
be codified at 45 CFR Parts 170 and 171) [hereinafter Final Rule].
3 FTC staff’s comments can be found at https://www.ftc.gov/system/files/documents/advocacy_documents/ftc-staff-
comment-department-health-human-services-regarding-21st-century-cures-act-
interoperability/v190002_hhs_onc_info_blocking_staff_comment_5-30-19.pdf. As noted therein, FTC staff also
provided informal assistance to ONC in the course of the rule making process. Id. at 1.

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information. As the nation’s leading consumer protection agency, the FTC enforces (among
other statues) the FTC Act, which prohibits, inter alia, unfair or deceptive acts or practices in or
affecting commerce.4 Using its deception authority, the FTC may bring an enforcement action
against, for example, a health IT app developer whose promises—whether in the app’s privacy
policy, user interface, FAQs, or elsewhere—depart from its practices.5 Using its unfairness
authority, the FTC could also challenge a particular use or disclosure of health information as
unfair if it causes or is likely to cause substantial injury to consumers that is not reasonably
avoidable by consumers themselves and not outweighed by countervailing benefits to consumers
or to competition.6
FTC staff recognize the complex regulatory and enforcement charge that ONC and the
Department have sought to implement in the information blocking provisions of the Final Rule.
Our formal and informal input to ONC has been based on our experience and expertise in
competition and consumer protection matters generally, and in competition and consumer
protection in the health IT space, where the FTC and the ONC have long worked to benefit
health care consumers. We look forward to ongoing cooperation between our agencies to that
end.
4 15 U.S.C. § 45(a) declares unlawful “[u]nfair methods of competition in or affecting commerce, and unfair or
deceptive acts or practices in or affecting commerce” and empowers and directs the FTC to prevent most persons,
partnerships, or corporations from using such methods.
5 See, e.g., Compl., Pact, Inc., No. 2:17-cv-1429 (W.D. Wash. Filed Sept. 21, 2017),
https://www.ftc.gov/system/files/documents/cases/1523010pactcomplaint.pdf (alleging that mobile health app
developer misled consumers about payments and billing related to achieving health and fitness goals).
6 15 U.S.C. § 45(n)