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HHS Extends Comment Period for Interoperability Proposed Rules to June 3

By Mandy Roth  
   April 19, 2019

New documents also released for comment along with clarification of liability issue.

The race toward a key deadline to comment on U.S. Department of Health and Human Services (HHS) interoperability proposals has been extended to June 3, according to an announcement made this morning. Concerned parties across the nation were pushing toward the original May 3 deadline, with many, such as the AMA, requesting an extension.

In addition, HHS also shared other important news, inviting public comment on a second draft of the Trusted Exchange Framework and Common Agreement (TEFCA) that will support the full, network-to-network exchange of health information nationally, according to a news release. It also released notice of a funding opportunity to engage a non-profit, industry-based organization that will advance nationwide interoperability.

The new documents being released for comment are:

  • A second draft of the Trusted Exchange Framework (TEF)
  • A second draft of the Minimum Required Terms and Conditions (MRTCs) for trusted exchange
  • A first draft of a Qualified Health Information Network (QHIN) Technical Framework. These documents will form the basis of a single Common Agreement that QHINs and their participants may adopt. This Common Agreement will create baseline technical and legal requirements for sharing electronic health information on a nationwide scale across disparate networks.

HHS also released of a set of frequently asked questions (FAQs) from the Office for Civil Rights (OCR), addressing the Health Insurance Portability and Accountability Act (HIPAA) right of access as it relates to apps designated by individual patients and application programming interfaces (APIs) used by a healthcare provider’s electronic health record (EHR) system. This document clarifies a key issue: "Once protected health information has been shared with a third-party app, as directed by the individual, the HIPAA covered entity will not be liable under HIPAA for subsequent use or disclosure of electronic protected health information, provided the app developer is not itself a business associate of a covered entity or other business associate," according to a news release.

On February 11, HHS announced two proposed rules to support the seamless and secure access, exchange, and use of electronic health information. "The rules," according a news release, "would increase choice and competition while fostering innovation that promotes patient electronic access to and control over their health information. Together the proposed rules address both technical and healthcare industry factors that create barriers to the interoperability of health information and limit a patient’s ability to access essential health information. Addressing those challenges will help to drive an interoperable health IT infrastructure across systems, enabling healthcare providers and patients to have access to health data when and where it is needed.

"This extension responds to requests from a variety of stakeholders," HHS said in the release. "The Centers for Medicare & Medicaid Services (CMS) and ONC understand that both rules include a range of issues having major effects on healthcare. The extension of the public comment deadline will maximize the opportunity for meaningful input and further the overall objective to obtain public input on the proposed provisions to move the healthcare ecosystem in the direction of interoperability."

Last month as HIMSS, the nonprofit association focused on health information technology and management systems, prepared to meet the original deadline for the HHS interoperability proposals, representatives shared the following concerns they had during a session with the media:

  • The cost of compliance could stifle innovation
  • New rules could complicate efforts to relieve provider burden
  • Price transparency could be too transparent 
  • Definitions of key terms are crucial 
  • There are issues related to patient data matching
  • No API standardization will add a layer of complication
  • ADT conditions stimulate great interest
  • Concerns whether the budget would be able to support the additional work and resources needed, particularly by ONC

HealthLeaders reached out to HIMMS for comment about the extension, but the organization did not have a comment to share at deadline.

More information is available on the following topics:

Mandy Roth is the innovations editor at HealthLeaders.

Photo credit: Shutterstock


Comment period for two proposed interoperability regulations has been extended to June 3.

Second drafts of Trusted Exchange Framework and Minimum Required Terms and Conditions  for trusted exchange also released for comment.

First draft of Qualified Health Information Network Technical Framework released for comment.

HHS clarifies liability issues related to third-party apps.

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