HIMSS Submits Recommendations on EU Health Data Space, Data Governance, Cross-Border Care, HERA

HIMSS has submitted observations and recommendations to the European Commission on European Health Data Space (EHDS), the Proposal for a Regulation on Data Governance, the Cross Border Care Directive, and European Health Emergency Preparedness and Response Authority (HERA), items that were open for feedback and consultation responses through the Commission.

European Health Data Space

HIMSS noted EHDS will be a core tool in allowing European partners to collaborate to build more sustainable and resilient healthcare systems.

Recommendations focused on several key areas:

• Enhance uptake of existing interoperability standards, supporting this work through the Global Consortium for e-Health Interoperability
• Move current guidance on use of standards to a stronger legal base, facilitating routine sharing of health data
• Consult across industry, academia and patient communities during development of sector specific legislation to complement the Data Governance Act
• Consider special and distinct rules for health data altruism organizations
• Address the removal of real and perceived barriers to cross-border movement of health data
• Ensure European citizens, care providers and researchers can benefit from high quality FAIR (Findable, Accessible, Interoperable, and Reusable) data

HIMSS looks forward to the opportunity to engage in future dialogue as this initiative develops. Read the full feedback letter: EHDS Feedback from HIMSS (in partnership with Personal Connected Health Alliance).

Data Governance Act

HIMSS welcomes the Proposal for a Regulation on Data Governance (Data Governance Act) as it can provide a much-needed governance framework for the sharing of data to build a stronger data-based economy in Europe and worldwide.

Recommendations focused on several key areas:

• Work closely with international partners to ensure future implementing legislation allows collaboration with business, academic and innovation communities in third countries
• Provide additional guidance on the general prohibition on exclusive agreements on the sharing data held by public sector organization and how exceptions may apply
• Ensure that where data altruism organizations handle health data donated directly by citizens, such organizations are held to a high level of accountability
• Ensure any health sector specific legislation on data sharing mandates the use of standards before the legislation is adopted.

HIMSS, a founding partner of the Global Consortium for e-Health Interoperability, is ready to work with the European Commission to achieve better health outcomes and to ensure interoperability allows health data to be FAIR – findable, accessible, interoperable and reusable.

Read the full feedback letter: Data Governance Act Feedback from HIMSS (in partnership with Personal Connected Health Alliance).

Cross-Border Healthcare Directive

HIMSS and PCHAlliance urge the European Commission to work closely with healthcare professionals and patient stakeholder groups to explore every potential to increase the use of the Cross Border Care Directive.

Recommendations focused on several key areas:

• Ensure the appropriate secure digital infrastructure is in place to support safe patient care across EU borders so patient information can be securely shared
• Explore how the Member States can be supported in ensuring that national digital health strategies also consider cross-border care provision
• Work closely with the Member States to support further development of the ERNs and to explore the potential of the directive to cover access to second opinions and information sharing between healthcare professionals for all medical conditions
• Assess as fully as possible the extent to which information on cross-border care is available to European patients and healthcare professionals
• Conduct a full exploration of use of social media and peer-to-peer information sharing to increase awareness among patients
• Address the information needs of healthcare professionals so that they can effectively signpost to patients how they may be able to make use of care in another Member State.

HIMSS and PCHA look forward to sharing more substantive thoughts in the next consultation stage, including insight on digital tools that can help the directive to better support access to care across all populations and regions. HIMSS can also provide relevant materials and learnings from the Global Consortium for eHealth Interoperability.

HIMSS would support outreach work and information dissemination through its channels, which reach patients, patient advocates, doctors, nurses and both primary and secondary care provider organizations.

Read the full feedback letter: Cross-Border Healthcare Feedback from: HIMSS (in partnership with Personal Connected Health Alliance).

European Health Emergency Preparedness and Response Authority (HERA)

HIMSS and PCHA welcome the European Commission’s intention to create the Health Emergency Preparedness and Response Authority (HERA) as a standalone body.

HERA would ensure European Union preparedness and help establish a stronger European Health Union, a revamped cross-border health threats legal framework and extended and improved crisis-related mandates that make relevant medical countermeasures available for serious threats to health.

HIMSS and PCHA noted learnings from the creation of the United States Biomedical Advanced Research and Development Authority (BARDA) will be helpful.

Recommendations focused on several key areas:

• Similar to BARDA, HERA must play a critical role in innovation.
• HERA should be provided additional authority to promote innovation through industry assistance and partnerships.
• The European Commission should ensure HERA includes a strong mechanism for coordination with other organizations, bodies and initiatives that have competences in the emerging diseases field in Europe and with allies across the globe.
• It should be the policy of HERA to work with the appropriate agencies and industry partners to ensure security and cybersecurity are critical considerations for any innovations and in all actions led by the agency.
• HERA should have a permanent structure established with different degrees of operational roles and infrastructure that can be activated quickly when needed.

HIMSS and PCHA ask that the European Commission move forward with meeting objectives and establishing HERA.

Read the full feedback letter: HERA Feedback from HIMSS (in partnership with Personal Connected Health Alliance).

Originally published Feb. 2, 2021; updated Feb. 12 and Feb. 26, 2021.