Lobbying by HIMSS Europe

HIMSS Europe

HIMSS

one-stop-organisation for all health IT-related information, knowledge and advice, and offer an unrivalled perspective on what’s happening in the world of health and care IT in Europe.

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ID: 203472036005-94

Lobbying Activity

Response to A European Health Data Space

28 Jul 2022

HIMSS, the Healthcare Information and Management Systems Society, welcomes the European Commission’s proposal for the European Health Data Space (EHDS). As a global advisor, thought leader and member-based society committed to reforming the global health ecosystem through the power of information and technology, we are pleased to see that the European Union is nurturing the ongoing digital health transformation to a very high standard and seeking cooperation with third countries and international organisations to build stronger global health systems. HIMSS stands ready to support the legislative process of the EHDS and urges the European Institutions to pay attention to the particular issues listed below: 1. Clarity of definitions and coherence with other legislation The terms data holder, recipient and user in Article 2 require further careful assessment to ensure that they are clear to all stakeholders, and that their use is coherent with the same or similar terms used in the GDPR, DGA, Data Act and MDR. The current wording allows uncertainties, risking fragmented interpretations of the law. HIMSS recommends testing definitions with a range of user groups and would be happy to engage its interest communities to help assess the understandability of key terms. As COVID-19 demonstrated, clearly defined access to and usage of data will help other bodies access data for research, preparedness, and response purposes. HIMSS urges the Commission to ensure that rules on aggregated data are consistent across the EU, to foster cooperation between countries to underpin timely life-saving solutions. 2. Support to interoperability HIMSS warmly welcomes the emphasis on EHR interoperability and stands ready to support the wider initiative through its extensive engagement with standards development organisations. HIMSS urges the Commission to address the EHRs function in a global market and to ensure that global as well as European standards are addressed within any delegated acts that may be developed. 3. Engagement with third countries The EHDS is by definition European, but health and disease know no borders. While the current proposal outlines how third country national data access bodies may engage with the EHDS, the extent to which researchers from outside the EU may collaborate with their EU colleagues remains under the terms of GDPR Article 9(4) which risks that the research community will face a fragmented legal landscape. 4. Building trust and digital skills The need to build trust in the EHDS among patients, healthcare professionals and researchers is acknowledged in the proposal. HIMSS urges the Commission to re-assess if the reporting requirements set out in Article 39 and the obligations set out in Article 38 are sufficient to successfully build trust. HIMSS particularly welcomes the initiative to include quality labelling of wellness apps and urges the Commission to make good use of the recently started Label2Enable project. The mandatory registration of health data required in Article 7 is welcomed, but it must be supported by implementing legislation that draws on the experience of stakeholders and supports the development of data registration skills. 5. Support to Member States The EHDS package includes significant budgetary allocation as well as recognition of capacity building. To ensure effective use of the available budgets the European Commission should ensure that a common and standardised bench-marking model is used to assess Member States’ capacity to implement the EHDS and to measure compliance, in particular with the adoption of the priority tools for primary use of data. HIMSS has significant experience helping Member States with such assessments and is ready to share our learnings.

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Response to European Health Emergency Response Authority

24 Feb 2021

HIMSS and PCHA welcome the Commission’s intention to create the Health Emergency Preparedness and Response Authority (HERA) as a standalone body. Such a step would ensure EU preparedness as well as be a key element in establishing 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. The creation of HERA represents a significant and relevant step forward in creating a coordinated mechanism for crisis response for emerging health threats, such as infectious diseases like COVID-19. The lack of a coordinated mechanism for exchanging information, taking emergency measures (i.e., medical equipment acquisition, centralization of epidemiological information, lack of information on reliability of diagnostic tests, etc.), has resulted in a fragmented response characterized by a poor ability to act collaboratively during the current pandemic, and the need for mutualising efforts at the EU level. As noted, the creation of the United States Biomedical Advanced Research and Development Authority (BARDA) shows that centralised investments in health preparedness and expansive government-wide coordination initiatives can be key in enabling and accelerating the development of new countermeasures and surge manufacturing capacities when needed. At EU level a further challenge exists in driving collaboration across 27 Member States, but the learnings from BARDA will nonetheless be helpful. Along the same lines as BARDA, HERA must also play a critical role in innovation. BARDA is tasked with supporting innovation to reduce the time and cost of medical countermeasures and spur further advanced research and development of these products. This is accomplished through promotion of technologies that assist in advanced development, including investments in research tools that promote strategic initiatives such as rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies. We recommend that HERA also be provided additional authority to promote innovation through industry assistance and partnerships. BARDA has taken a similar innovation mandate as an opportunity to work with partners across government, industry, and academia to create new ways to produce medical countermeasures that are timely, reliable, and cost effective. The Commission should also ensure that 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, such as the European Centre for Disease Prevention and Control, European Medicines Agency, World Health Organization, and BARDA. HIMSS and PCHA welcome the development of a centralised information sharing architecture, and believe 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. As the COVID-19 pandemic has shown, there is not always time to ramp-up a response to cross-border health threats. Therefore, at a minimum, HERA should have a permanent structure established with different degrees of operational roles and infrastructure that can be activated quickly when needed. While HIMSS and PCHA recognize there could be challenges in providing HERA full end-to-end authority as well as streamlining EU-level initiatives on medical countermeasures for serious cross-border threats to health, we ask that the Commission move forward with meeting these objectives and establish HERA.

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Response to Evaluation of patient rights in cross-border healthcare

11 Feb 2021

• HIMSS and PCHA warmly welcome the Commission’s intention to examine the effectiveness and efficiency of the operation of the Cross Border Care Directive, and urge the Commission to work closely with healthcare professionals and patient stakeholder groups to explore every potential to increase its use. • While we note that the eHealth provisions of the Directive, will be evaluated in the context of the European Health Data Space (EHDS), we urge the Commission not to miss the opportunity of ensuring that the appropriate secure digital infrastructure is in place to support safe patient care across EU borders. This is needed to ensure that patient information can be safely and securely shared, including EHRs, electronic prescriptions, laboratory and diagnostic reports, and medical images, referral, discharge letters and clinical and nursing notes. • We are delighted to note that the role of the eHealth Network will be assessed in the context of the EHDS and would strongly urge the Commission to explore how the Member States can be supported in ensuring that national digital health strategies also consider cross-border care provision. • With HIMSS and PCHA focused on ensuring health equity, we look forward to sharing more substantive thoughts in the next consultation stage on digital tools can help to ensure that the Directive can better support access to care across all populations and regions. In this context we would draw your attention to the Global Consortium for eHealth Interoperability set up in 2020 by HIMSS, HL7 International, and IHE International to share lessons learned, best practices, and expert guidance to rapidly drive adoption of standards-based health IT interoperability. We would be delighted to share materials and learnings from this initiative with Commission to help ensure that cross-border care, whether delivered in person or remotely, makes best use of digital health tools to support cross-border care. • We note that ERNs will be addressed in the review and urge the Commission to 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, including those not covered by the disease groups addressed in the ERNs. • We note that despite full implementation in all Member States, uptake of cross-border care by patients remains low. While it is, of course, understandable that patients will want to seek care close to home where possible, we urge the Commission to assess as fully as possible the extent to which information on cross-border care is available to European patients and healthcare professionals. We would urge a full exploration of use of social media and peer to peer information sharing to increase awareness among patients, and to also 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 would be delighted to support any outreach work, awareness building and information dissemination through its many channels which reach patients, patient advocates, doctors and nurses, as well as both primary and secondary care provider organisations.

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Response to Legislative framework for the governance of common European data spaces

5 Feb 2021

HIMSS welcomes the proposal for a Regulation on Data Governance, which it believes will provide a much-needed governance framework for the sharing of data to build a stronger data-based economy in Europe and worldwide. As an organisation in the health sector working closely with policy, academic and industry partners, HIMSS is delighted to note the special recognition given to the need for certain sector specific legislation to complement the proposed Regulation, and looks forward to the further consultations on the legislation to be proposed in the context of the European Health Data Space. Recognising that disease knows no borders and that the challenges of developing sustainable and resilient health systems must be addressed through wide collaboration, HIMSS notes the options for future implementing legislation provided for in the proposed Regulation and would urge the Commission to work closely with its international partners to ensure such legislation allows business, academic and innovation communities in third countries to work closely with their European counterparts. While we welcome the general prohibition on exclusive agreements on the sharing data held by public sector organisation, we note that a derogation may exist where this is in the general interest. We urge the Commission to provide further guidance in the recitals to the final Regulation as to the definition of the term and how exceptions may apply. This will be crucial in encouraging the creation of data intermediary organisations, and to developing trust in them among citizens. Recognising that citizens are often keen to make their data available for research purposes, HIMSS welcomes the opportunity the proposed Regulation provides for the creation of data altruism organisations. The success of such organisations will depend heavily on the trust of citizens, which is in turn heavily dependent on a high level of transparency on the operation and regulation of such organisations. HIMSS, therefore, calls on the Commission to ensure that where data altruism organisations handle health data donated directly by citizens, such organisations are held to a high level of accountability. This should include the mandatory registration and certification of such organisation, rather than the voluntary registration foreseen for general data altruism organisations in Articles 1 (1) (c) and 17(1). HIMSS welcomes the reference to the use of technical interoperability standards in recital 41 and Article 27 in the context of the work of the European Data Innovation Board (EDIB). HIMSS urges the Commission to ensure any health sector specific legislation on data sharing mandates the use of standards before the legislation is adopted. As a founding partner of the Global Consortium for e-Health Interoperability, HIMSS stands ready to work with the Commission to leverage existing and emerging interoperability standards and the latest implementation guidance to achieve better health outcomes to ensure that interoperability allows health data to be FAIR – findable, accessible, interoperable and reusable.

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Response to A European Health Data Space

3 Feb 2021

HIMSS warmly welcomes the roadmap and inception impact assessment on the EHDS, which will be a core tool in allowing the European partners to collaborate to build more sustainable and resilient healthcare systems. We note and welcome the recognition of the fragmentation of digital standards and limited digital interoperability in the health sector. The recently adopted agreement on vaccine certification underlines the need for close attention to technical interoperability and a harmonized governance approach. Accordingly, we urge the Commission to use both directly applicable legislative tools and targeted support mechanisms to enhance uptake of existing interoperability standards and stand ready to support this work through the Global Consortium for e-Health Interoperability, which we have founded in partnership with IHE International and HL7 International. Recognising the importance of standards in the operation of the EHDS, we welcome the intention of the Commission to assess the current eHealth Network. We urge the Commission to consider the potential benefit of a body with a wider mandate, which could move current guidance on use of standards to a stronger legal base which facilitates routine sharing of health data for care and research. Looking at the proposed policy options, HIMSS looks forward to health sector specific legislation to complement the Data Governance Act outlined in Objective 1, and urges the Commission to consult widely during its development across industry, academia and the patient community. We believe that it is important that such legislation can foster the trust of citizens and patients so that they will contribute their data through the data altruism organisations foreseen in the Data Governance Act, and urge the Commission to consider special and distinct rules for health data altruism organisations. These could ensure that such organisations may be held accountable to higher standards of transparency that those handling less sensitive data, which will be of great importance in building trust in data donation. The digital health economy is growing in Europe and globally, but it is often slowed in its development by real and perceived barriers to cross-border movement of health data. HIMSS therefore welcomes the indication given in Objective 2 that the removal of such barriers will be addressed and looks forward to a more detailed description of proposed initiatives. With reference to Objective 3, HIMSS concurs that artificial intelligence has potential to drive significant innovation in healthcare. Noting that AI is fuelled by data, it is of key importance that the data that is made shareable through the EHDS is suitable for use in training algorithms. HIMSS urges the Commission to ensure that attention to standards focuses on data interoperability, and on its quality and fitness for purpose, ensuring that European citizens, care providers and researchers can benefit from high quality FAIR (Findable, Accessible, Interoperable, and Reusable) data. HIMSS notes that further targeted and open consultations will be launched as the EHDS plan is developed and stands ready to support the Commission services in developing the initiative through such consultations. We look forward to the opportunity to engage in the appropriate dialogue on this matter.

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