August 12, 2016

eHealth/Health IT Ties Between the EU and US Strengthened Following Agreement by Government Agencies on New Roadmap

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On July 28, the European Commission's Directorate General for Communications Networks, Content and Technology (DG CONNECT) and the United States Department of Health and Human Services (DHHS) announced their agreement on an updated roadmap for the Memorandum of Understanding on cooperation surrounding health related information and communication technologies (the MoU).

The MoU was entered into in December 2010 to demonstrate the shared dedication of EU and US authorities in addressing challenges concerning eHealth/Health IT ("eHealth" being the European term for what is typically referred to as "Health IT" in the US). The first roadmap of MoU actions was published in March 2013, and focused on outlining the vision, challenges and scope of two priority areas: "International Interoperability" and "eHealth/Health IT Workforce Development." In December 2015, DHSS and DG CONNECT agreed to add a third priority area to the MoU roadmap, namely "Transatlantic eHealth/Health IT Innovation Ecosystems."

The most recent roadmap was published on July 28, 2016, following consultations with key stakeholders, held in parallel in the EU and US from December 22, 2015, to March 15, 2016. The revised roadmap retains the three priority areas previously agreed on, and develops them as follows:

  • International Interoperability: Efforts to date have focused on analyzing requirements for the structure and content of an International Patient Summary (IPS). The IPS is intended to enable the interoperable representation and communication of information about a patient's immunizations, allergies, medications, clinical problems, past operations and implants. The revised roadmap confirms the EU and US authorities' commitment to promote and advance an IPS standard to enable people to access and share their health information for planned or emergency care anywhere and as needed. The US, in particular, has recently been focused on interoperability with the US Food and Drug Administration (FDA) issuing draft guidance in January 2016 on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. In addition, the US Congress has been active in this area, with the Senate passing the Improving Health Information Technology Act, which targets electronic health records (EHRs) in an effort to make them more interoperable. However, the legislation has not received full approved from Congress.
  • eHealth/Health IT Workforce Development: The first phase of this priority area, which was completed in May 2015, involved identifying and addressing competency and knowledge deficiencies among staff in the eHealth/Health IT professional workforces. The next phase will involve continued collaboration with EU and US individuals and organizations, to promote development of a global workforce professionally prepared to deploy eHealth/Health IT systems.
  • Transatlantic eHealth/Health IT Innovation Ecosystems: This newly added priority area aims to encourage innovation in the eHealth/Health IT industry by way of EU and US collaborations, and to link these innovations to other roadmap priority areas. By way of example, this could involve building transatlantic partnerships between EU and US cities that are interested in solving similar eHealth/Health IT challenges, or identifying key EU and US stakeholders and enlisting their support. The specific actions, deliverable and deadlines which flow from these priority areas are set out in an Annex to the revised roadmap. The Annex, which covers a 12- to 18-month timeframe, will be regularly updated to keep stakeholders informed.

The revised roadmap and accompanying Annex signal a renewed commitment to transatlantic partnerships and cooperation in the eHealth/Health IT sphere, which will be welcome news to most international operators as well as to consumers, who may expect to receive more streamlined, transferable and accessible eHealth products and services in the near future.

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