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#EAPM - Update: A European strategy for data in health care in personalised health-care era 

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On 19 February, the European Commission set its stall out concerning its digital policy for the next five years and, as a significant part of its policy, it wants to promote electronic health records based on a common European exchange format to give citizens secure access to and exchange of health data across the EU. This effort builds on a recommendation it released in 2019, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

EAPM is delighted to see the progress made by the Commission, not least because a great many of our organization’s key policy areas have been addressed in the proposed digital transformation that aims t
o reflect the best of Europe: open, fair, diverse, democratic and confident. In fact, EAPM has been hard at work on the issue of the application of big data and Artificial Intelligence (AI) in health-care systems since 2013, and we relish working with member states and the Commission on establishing our role in achieving this. This will be discussed in our upcoming conference, which will be fully referenced later.  An article that sets out these key policy areas is in the following academic publication entitled: Artificial Intelligence: Power for Civilisation – and for Better Healthcare.

As far as AI is concerned, it is simply vital that Europe leads the way as far as its implementation in health care is concerned. AI covers systems that display intelligent behaviour by analysing their environment and then taking actions to achieve specific goals. This is done with some degree of autonomy.   The EU and member states need a solid framework, and the EU needs to be better prepared if we are to keep up, let alone take a lead, in the context of AI and its promise. 

A co-ordinated EU approach is certainly required, especially as we already have brilliant researchers, excellent laboratories, forward-looking entrepreneurs, and strength in robotics.  

Co-operating on data: The missing element in bringing real innovation to Europe’s health-care system

This build on Europe’s most conspicuous move so far towards cooperating on data is the EU1MG initiative. This was formalized in 2018 in the Declaration of Cooperation “towards access to at least 1 million sequenced genomes in the European Union by 2022,” and is now making progress towards its avowed goal . The declaration, launched on April 10, 2018, has so far been signed by 22 EU Member States with Germany signing a few weeks ago and is also open to all Member States of the European Economic Area and the European Free Trade Association. Beyond the initial goal of at least 1 million sequenced genomes in the EU by 2022, it envisages a larger prospective population-based cohort.  An overview of this initiative is set out in the following linked article.

The potential for health care

Follow-up on the Commission’s White Paper on Artificial Intelligence  to be expected, including safety, liability, fundamental rights and data. Much of the fine print for legislation will depend on feedback the Commission is set to receive in the coming months from industry, civil society and national governments. The EU’s executive arm could decide for example to update the product liability directive, which creates a legal responsibility regime for defective products. At the same time, the Commission argued in its White Paper that high-risk AI technology should undergo rigorous testing before it can be deployed or sold within the EU’s vast internal market, pitching the introduction of so-called “conformity assessments” for AI systems that pose significant risks in areas including recruitment, health care, transport and law enforcement. “So-called high-risk AI — this is AI that potentially interferes with people’s rights — have to be tested and certified before they reach our single market,” Commission President Ursula von der Leyen said on 19 February.

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In addition, strengthening  and  extending  the  use  and  re-use  of  health  data  is  critical  for  innovation  in  the  health-care  sector.  It  also  helps  health-care  authorities  to  take  evidence-based  decisions  to  improve  the accessibility,  effectiveness  and  sustainability  of  the  health-care  systems, and contributes  to  the competitiveness  of  the  EU’s industry. Better  access to health data can significantly support the work of regulatory bodies in the health care  system, the assessment of medical products and demonstration of their safety and efficacy.

A right to access and control health data – Policy Framework

Citizens  have  the  right  in  particular  to  access and  control  their  personal  health  data  and  to  request  their  portability,  but  implementation  of  this right  is  fragmented.  Working  towards  making sure that every citizen has secure access to their Electronic Health Record (EHR) and  can ensure the portability of his/her data  – within and across borders  –  will improve access to  and quality of care, cost effectiveness of care delivery and contribute to the modernization of  health systems.

Citizens  also  need  to  be  reassured  that,  once  they  have  given  consent  for  their  data  to  be  shared, the health-care systems uses such data in  an ethical manner and  ensure that the  given  consent can be withdrawn at any time. Health is an area where the EU can benefit from the data revolution, increasing the quality of healthcare while decreasing costs.

On a broader perspective, Europe’s goal should be integrating AI into Europe’s health-related operations to improve clinical care, drive innovative therapies and treatments, and make health-care systems more efficient. Europe needs a broad uptake of AI in the economy, and in this context the role of start-ups and small to medium-sized enterprises (SMEs) is pivotal, both in terms of its scale and its vitality.  EAPM set outs it policy recommendations in optimizing SME Potential in Modern Healthcare Systems: Challenges, Opportunities and Policy Recommendations, at the following link. 

European initiatives to build voluntary Ethics Guidelines for AI in health care are welcome, as these would help set world standards for AI, and simultaneously give the reassurance needed to society to trust these technologies as well as for industry to invest further.

The right environment - Keeping the person in personalised health care

Of course, as with any new technology, it is important to ensure adequate protection of the public interest as well as promoting valuable innovation. The context should be protective of the citizen, but should allow for experimentation and should support disruptive innovation across the EU.

In the context of AI, a common question is whether the existing regulatory framework is fit for purpose. The art of good regulation is finding the right balance which is a clear from our consultation. Systems for approving new medical devices must provide pathways to market for important innovations while also ensuring that patients are adequately protected.

Lest we forget, the practice of health care has strong ethical roots. This must not change with AI. Addressing accountability, privacy, transparency, equity, safety are necessary to ensure trust in this context.

EU-wide standards are required, and a key goal should be building trust by promoting the engagement of all health-care stakeholders to understand the technology, and training and education for patients, medical professionals, health-care organizations, policymakers and governments

EAPM Presidency Conference – Registration Open

And a timely reminder to conclude, should such be necessary - registration is open for EAPM’s upcoming conference – our 8th – which will take place under the auspices of Croatia’s Presidency of the EU on 24 March in Brussels, and will be focused on EAPM’s key theme of bringing innovation into Europe’s health-care systems.

Here’s the link to register, for your convenience as well as thelink to the agenda – there are already more than a hundred registrations for the conference, which is sure to be a red-letter occasion for all health-care matters. 

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