Electronic Health Records

Integration & Interoperability News

HELP Committee Works to Support 21st Century Cures Act

Interoperability and health information exchange remain the cruces of Congressional efforts to promote medical innovation.

By Kyle Murphy, PhD

Efforts to advance interoperability and health information exchange received a shot in the arm Wednesday when the Senate Health Committee marked up seven bills in support of the 21st Century Cures Act that drew widespread support in the House of Representatives last July.

“Today we marked up seven more bills incorporating about 15 more bipartisan proposals and that—with the seven bipartisan bills passed last month — gives a substantial start to our innovation companion to the 21st Century legislation passed by the House of Representatives,” Senator Lamar Alexander (R-TN), Chairman of the Senate Committee on Health, Education, Labor & Pensions (HELP) said in a public statement.

According to Alexander, advancing these bills swiftly will enable funding for medical innovation to get into the appropriate hands in a timely manner.

 “I want to finish our work promptly so we can hand to Sen. McConnell a conclusion on the innovation bill, as well as a bipartisan agreement on a surge of funding for the National Institutes of Health so he can put them on the floor,” he claimed.

The House act for which the Senate HELP is working to develop companion legislation grew in prominence over the previous two years. That bill devotes an entire section to interoperability and health information exchange.

As defined by the bill, interoperable health IT has three characteristics:

(1) SECURE TRANSFER.—The technology allows the secure transfer of all electronically accessible health information to and from any and all health information technology for authorized use under applicable State or Federal law.

(2) COMPLETE ACCESS TO HEALTH INFORMATION.—The technology allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law without special effort by the requestor of such health information.

(3) NO INFORMATION BLOCKING.—The technology is not configured, set up, or implemented to information block, as defined in section 3010A(d).

To support interoperability, the 21st Century Cures Act also calls on the Department of Health & Human Services (HHS) and its departments to provide enforcement through EHR decertification:

Under any program kept or recognized under subparagraph (A), the Secretary shall ensure that beginning January 1, 2019, any qualified electronic health records that do not satisfy the certification criteria described in subparagraph (B) or with respect to which the vendor or other entity described in clause (i) does not satisfy the requirements under such clause (or is determined to be in violation of the terms of the attestation or other requirements under such clause) shall no longer be considered as certified under such program.

Likewise, health IT vendors would be responsible for providing accurate pricing information about additional costs or fees "to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of capabilities to which such record is to be certified under this section; or in connection with any health information generated in the course of using any capability to which the record is to be so certified."

The 21st Century Cures Act itself mirrors the work of the Executive Branch on the Precision Medicine Initiative. At the heart of both is the need for ensuring the accessibility of data for providers, patients, and researchers.

The following bills received the HELP Committee's bipartisan support on Wednesday:

  • Advancing Hope Act of 2015 (S1878)
  • Advancing Breakthrough Medical Devices for Patients Act of 2015 (S1077)
  • Medical Electronic Data Technology Enhancement for Consumer’s Health (MEDTECH) Act (S1101)
  • Medical Countermeasures Innovation Act of 2015 (S2055)
  • Combination Products Innovation Act of 2015 (S1767)
  • Patient Focused Impact Assessment Act of 2015 (S1597)
  • Adding Zika to the Priority Review Voucher Program Act (S2512)

With the exception of the first, fourth, and last, the bills focus on defining the role of the Food and Drug Administration (FDA) to balance federal oversight and medical innovation in the name of progress.

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