On 12 October, ACT | The App Association brought together industry experts and policymakers to discuss digital health policy in the European Union (EU) and in other parts of the world.
The event opened with a keynote message by Member of the European Parliament (MEP) Deirdre Clune, who highlighted the importance of supporting the exchange of health data by increasing efficient access to data and introducing clear rules. Ms Clune emphasised that the European Health Data Space (EHDS) Regulation represents an opportunity to set these rules, harmonise and simplify them at the EU level and, ultimately, boost innovation across the EU.
‘By facilitating exchanges of health data through an open single market we can ensure increased accessibility, availability and affordability of healthcare, stimulating innovation for better treatments and outcomes and enabling SMEs to succeed’. – MEP Deirdre Clune
Following Ms Clune’s keynote remarks, Mr Sidy Diop from Deloitte Finance presented the new App Economy in Europe report, giving an overview of the app development sector and key figures on the state and growth of the app economy over the last year. Notably, the use of apps in the health sector increased significantly. During the first year of the COVID-19 pandemic, downloads of health apps in the UK more than tripled (+226 per cent) and doubled in the UK (+104 per cent). Read a full summary of the report in this blog post and the full report here.
Next Mr Yiannos Tolias, legal lead on AI and AI liability of the Digital Health Unit at the Directorate-General for Health and Food Safety (DG SANTE), presented the main elements of the EHDS Regulation. Currently, neither individuals nor policymakers, researchers, or health services providers can easily access their own and/or patient data from hospitals and other healthcare providers. To empower individuals to access their health data for primary uses, the Commission already put in place the MyHealth@EU infrastructure, in which 11 Member States currently participate, and all other Member States are expected to join by 2025. To facilitate the secondary use of health data for research and analysis, the Commission will establish the HealthData@EU infrastructure. The EHDS also aims to improve the interoperability of electronic health records (EHRs) and exchanges of health data. Mr Tolias highlighted the importance of linking the EHDS with other existing regulations and proposals like the General Data Protection Regulation, the Data Governance Act, the EU Cybersecurity Framework, the AI Act, and various medical device regulations.
To kick off the panel, the founder and chairperson of the App Association, Mike Sax, welcomed the speakers and recalled that everyone in the room has the goal of empowering people to take care of their health. App developers create innovative apps to advance digital health, making the safe and secure exchange of health data and, thus, the EHDS Regulation crucial for them.
‘At the App Association many companies try to empower people to take care of their health; maybe they are small, but they play an essential part in our life. These companies are founded for a reason, not to make big money, but to improve the world and our lives’.—Mike Sax
Mr Vincent Keunen, CEO and founder of App Association member company Andaman7, shared the story of him and his son both surviving cancer diagnoses. Shaped by his experience of struggling to access his own and his son’s health data and the difficulties of sharing it with different doctors, Vincent decided to develop a free app to solve these issues. Andaman7 not only allows users to store their health data directly on their phones but also enables them to easily share their data with healthcare providers and doctors. With users’ consent, Andaman7 also shares health data analyses with stakeholders in the pharmaceutical and biomedical sectors to advance medical research.
Following Mr Keunen’s remarks, Ms Birgit Morlion, policy officer at the Directorate-General Communications Networks, Content and Technology (CNECT), highlighted the importance of public-private cooperation to ensure that the EHDS succeeds, and small and medium-sized enterprises (SMEs) thrive. As citizens and patients, we are the owners of our health data, Ms Morlion emphasised, and with the EHDS we can have access to that data. Additionally, the EDHS can be the tool that provides the fuel to health research that requires high-quality data and, thus, enable subsequent innovation.
Mr Thomas Hellebrand, policy manager at DIGITAL EUROPE, spoke from his personal experience, how in the Netherlands he doesn’t have access to his electronic health records, but in other European countries and non-EU countries, people do. To him, the EHDS is an opportunity to start building a health data ecosystem across all of Europe.
Mr Keunen shared his excitement for the opportunities the EHDS offers for cross-national collaboration in health data. Nonetheless, he acknowledged Europe still faces many problems and is lagging behind the United States in digital health provision, as demonstrated by the fact that the Andaman7 app is compatible with more than 85 per cent of U.S. hospitals and less than 1 per cent of hospitals in Europe.
Further highlighting differences between the United States and the EU on the topic of digital health, Mr Brian Scarpelli, senior global policy counsel at the App Association, stressed that there are a lot of lessons to be learned from the United States, for example on issues like liability, payments, terminology, and coding. He also spoke about how the U.S. federal government’s declaration of a public health emergency during the COVID-19 pandemic waived many old requirements, ultimately boosting the uptake of connected health tools. The resulting data clearly demonstrates that the increased availability of a wide variety of digital health tools can and does improve health outcomes. Improving patient outcomes, boosting population health management, and promoting better conditions for health care professionals must be top goals of connected health initiatives like the EHDS, Mr Scarpelli stated.
Ms Morlion underlined that privacy and trust are key to increasing the uptake of digital health tools, and transparency towards patients is hugely important to create trust which is why the EHDS includes transparency requirements. Although the EHDS is soft law, Ms Morlion said building trust is a common effort, and we all have a role to play in it. App developers, for example, can set and help to adopt the right standards, by using quality labels, for example.
‘People are ready to share medical data if they see the added value and if they trust the healthcare professionals, companies or researchers with whom they are sharing their data’. – Birgit Morlion
Although Mr Keunen acknowledged the importance of building trust among patients and users and protecting them, he cautioned against adding more regulations or mHealth quality labels because it creates more compliance work for small businesses. Especially in the medical space, companies already have to comply with strict legislation, like GDPR and HIPAA and medical device regulations. First and foremost, Mr Keunen instead suggested taking a step-by-step approach and making a genuine digital market for health data the top priority.
Mr Thomas Hellebrand noted that because health remains a national competence in the EU, so any Commission Regulation cannot infringe national rules. National governments, he says, have to some extent failed to improve consumers’ and providers’ lives all over Europe, but the EHDS can mitigate those failures by providing a forum for international dialogue.
To support interoperability, Mr Keunen endorsed both offering financial incentives for sharing health records with healthcare providers and mandating that European hospitals use the Fast Healthcare Interoperability Resources (FHIR) application programming interface (API) that U.S. hospitals use. Using FHIR enables Andaman7 to connect with 10,000 hospitals in the United States, and not mandating it in the EU makes it impossible for SMEs like Andaman7 to connect with a large number of hospitals there.
Concerning the slow uptake of AI and uncertainties around AI liability in health, Mr Tolias highlighted two new Commission proposals to address the technical specificities of AI to increase confidence in using AI in healthcare systems.
To close out the event, all panellists shared their main takeaways. Mr Keunen believes that EHDS shows the desire at the EU level to improve digital health in the EU and emphasised that the time to act is now. Mr Tolias said the EU is acting fast and creating the necessary links for this new European Health Data Space from several points of view. Ms Birgit Morlion echoed the sentiment that speedy action is of the essence, and the COVID-19 pandemic showed that it is possible to keep moving ahead fast. Mr Hellebrand underlined that while the EHDS is generally supported by almost all stakeholders, the need to look at the Member States and what they do at the national level remains. Mr Scarpelli closed the discussion by emphasising that startups are the engine of this digital health transformation and reiterating the need to focus on the Member States, especially regarding issues like payments and reimbursements as they are absolutely vital to advancing a functioning European health infrastructure. In conclusion all panellists expressed their broad support for the EHDS and agreed that, although there is much work left to do, exchanges like this event help to make progress.