During the ongoing COVID-19 pandemic, the importance of digital solutions in providing lifesaving care to Europeans increased significantly. mHealth technologies mean digital health tools like wireless health products, mobile medical devices, software as a medical device, mobile medical apps, cloud-based portals and dashboards, and others. These tools have the demonstrated ability to assist in tracing COVID-19 cases, staying in touch with your doctor, improving your mental health, or monitoring a chronic disease. Several European member companies of the ACT | App Association are leaders in the mHealth space, including SyndoHealth, Andaman7, Brain+, and Intimind.
Challenges affecting European mHealth developers
Of course, developers face just as many challenges in mHealth as opportunities. The safe processing of sensitive health information, for example, is a key issue for developers as more and more data is exchanged online. Creating a pan-European approach to healthcare presents a specific set of challenges. Because health policies are not an EU competence but rather a prerogative of the Member States, this issue is particularly complex. For example, Member States’ approaches to how healthcare providers are paid for their services to patients differ significantly, which affects business models. These disparate approaches to healthcare governance across EU Member States creates one of the biggest disadvantages for companies offering mHealth solutions in the EU — there is no single market for digital health products or services. While mHealth apps are not inherently constrained by borders, the patchwork of health laws across the EU often holds them back.
Another big challenge is the uptake of mHealth technologies and integrating digital solutions into the actual delivery of healthcare services. The COVID-19 crisis has sped up this integration significantly. User trust and the app quality directly affect the uptake of mHealth technologies. These issues often stem from concerns about what is happening with user data, who is handling it, and where and why is it stored and processed. Another important question for users is whether an app is proven to deliver benefits and improve patient outcomes. Similarly, a lack of digital skills and data literacy can present a barrier to both patients and healthcare professionals who use the technology. Below we detail some of the policy considerations impacting mHealth app developers:
Horizontal laws affecting mHealth
As policymakers become more aware of the opportunities and issues in digital health, the EU is taking several steps to address these challenges and to support the digital transformation of health and care. First, several horizontal pieces of legislation set up a legal framework for the digital age that respect European values and principles and also apply to the healthcare sector. These laws include, for example, the General Data Protection Regulation and the Network and Information Security Directive. Similarly, the recently proposed Artificial Intelligence (AI) Regulation will also apply to mHealth solutions. This proposal employs a risk-based use case approach, under which health data will be considered high-risk. Therefore, mHealth apps using AI would require an ex-ante conformity assessment before they can enter the European market. Another important piece of horizontal legislation is the Data Governance Act, which is a part of the EU’s data strategy. With this Act, the Commission intends to boost the development of trustworthy data sharing systems – which are particularly important in the health sector.
Vertical mHealth laws
Second, vertical pieces of legislation that are more specific to the health sector include the Medical Device Regulation, that provides standards medical devices must meet to enter the European market, and the Cross-Border Care Directive, which allows European citizens to get healthcare in a Member State other than their home state. The European Commission is also currently consulting the public on a Common European Health Data Space. This survey aims to get feedback from public health, data protection authorities, and developers regarding their experiences with the collection, access, use, and re-use of health data. The Commission will use the outcomes of this consultation to determine the steps necessary to achieve a Common European Health Data Space. The consultation is open until the 26th of July, and the App Association will participate. If you have thoughts or insights to share, please let us know.
Soft laws and mHealth standards
In addition to hard laws, there are also industry-driven principles, codes of conduct, and standards. The Commission and the European standards body CEN are currently developing such a standard for mHealth apps. The result will be a health app assessment framework for the quality and reliability of health apps, composed of 82 questions that developers can answer themselves. Following the assessment, an app will receive a quality label comparable to the European energy efficiency label on household appliances. The App Association was extensively involved in the development of the draft language of this standard. We want this standard to be an opportunity for members to differentiate their product, not a barrier to entry into an already competitive market.
Digital health is a key issue for the App Association and as the world looks to our member companies during the pandemic, it’s an area in which we continue to monitor and engage. There is so much innovation in this field, and the importance of apps in health will only continue to increase. With a growing number of our members specialising in the mHealth field, we have the amazing opportunity to work with these innovative, lifesaving companies as they continue to develop and grow. We look forward facilitating an ongoing dialogue between our members and European policymakers to help small businesses thrive, bringing their innovative health solutions to patients across the EU.
Interested in more mHealth coverage? Check out episode 12 of Global Tech Swamp!