HHS' proposed interoperability rules: A timeline of key events

HHS' proposed interoperability rules have generated a significant amount of attention ahead of their anticipated finalization this month.

Here is a timeline of Becker's Hospital Review's coverage of the proposed rules, which would require the healthcare industry to adopt open data-sharing technologies to help patients more easily access their health information. 

Feb. 11, 2019: HHS publishes rules, issued by CMS and ONC, to give patients free access to their electronic health data. The regulations support the MyHealthEData initiative and 21st Century Cures Act. For the rules, CMS proposed requirements that Medicaid, the Children's Health Insurance Program, Medicare Advantage plans and Qualified Health Plans implement open data-sharing technologies to give enrollees immediate electronic access to their medical claims and other health data by 2020.

CMS' rule also targeted the removal of information blocking practices, proposing that providers or hospitals that unreasonably limit the availability of EHR information be publicly reported. ONC's proposal called for the adoption of standardized application programming interfaces to help patients gain easier access to their health data as well as implementing information-blocking provisions. 

Feb. 25, 2019: HHS says it will formally publish CMS and ONC's interoperability rule proposals on March 4 as well as open a 60-day comment period open to responses from the public until May 3.

April 19, 2019: HHS makes various announcements regarding its strategy toward achieving better health records exchange, including releasing additional information about HIPPA's relation to third-party applications. The agency said if an individual opts to share their protected health information with a third-party app, then the HIPAA-covered entity that stores that information is not liable for what happens to the person's data.

HHS also extends its public comment period for the two proposed interoperability rules until June 3.

May 13, 2019: The federal Health IT Advisory Committee's Information Blocking Task Force advances nearly 50 recommendations to ONC's proposed interoperability rule, including those related to security and privacy of electronic health data.

June 3, 2019: HHS closes the public comment period on the rule, which received more than 1,900 responses.

Dec. 16, 2019: The College of Healthcare Information Management Executives sends a letter to Congress claiming that the proposed interoperability rules lack adequate safety regulations to protect patients' sensitive information.

Jan. 22, 2020: Epic CEO Judy Faulkner emails several of the EHR giant's largest U.S. hospital clients asking them to voice their disapproval of HHS' proposed interoperability rules. Ms. Faulkner said the rules raise privacy concerns because they would allow third-party app developers use patient data without any transparency requirements.

Ms. Faulkner reportedly told Politico Epic would consider suing HHS depending on the data sharing regulations the agency includes in its final version of the interoperability rules. Rather than taking legal action, an Epic spokesperson told Becker's that the company would prefer to work with HHS to address the privacy concerns before the final rules are released.

Jan. 27, 2020: Epic releases a public statement to clarify its stance on HHS' proposed interoperability rule, saying that while it supports HHS' efforts to make data sharing better for patients, the rules present "serious risks to patient privacy."

Jan. 27, 2020: Cerner, Epic's largest EHR competitor, along with companies including Google, Apple and Microsoft express their support for HHS' proposed rules and meet with the Office of Management as members of the CARIN Alliance to discuss the rules. The alliance comprises more than 85 members, and in its key request asked the federal government to finalize and release the rules immediately.

Jan. 27, 2020: During the 2020 ONC Annual Meeting in Washington, D.C., HHS Secretary Alex Azar says the agency will pursue both patient empowerment as well as privacy in relation to expanding data sharing abilities under the proposed rules. He also addresses some of the pushback the rules have received: "Unfortunately, some are defending the balkanized, outdated status quo and fighting our proposals fiercely," he said. "I want to be quite clear: Patients need and deserve control over their records; interoperability is the single biggest step we can take toward that goal."

Jan. 30, 2020: A group of nearly 30 healthcare organizations and IT companies, including Apple, Microsoft, the American Medical Informatics Association and Academy of Family Physicians, send a letter of support to HHS and OMB, urging officials to swiftly release the finalized version of the rules.

Feb. 5, 2020: Sixty U.S. health systems sign Epic's letter opposing the proposed rules. The letter recommends making changes to the rules, including instituting a timeline of at least 12 months to prepare for the regulations and 36 months to develop new technology the rule would require.

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