Collaborating for Digital Health and Care in Europe

Upcoming legislation that affects data, health data, businesses and citizens

EHTEL is happy to offer a brief outline of the current state-of-play of three proposed upcoming European legislative acts.

Meanwhile, EHTEL is also working, for its members, on a more detailed briefing note about the latest piece of intended legislation and its implications.

Look out for this in-depth EHTEL briefing note – likely in May 2022 – once the European Union (EU) publishes more detail on its proposed European Health Data Space.

A whole landscape of legislative developments

There has been rapid development on data governance in Europe at least since 2017, but in particular since 2020. Today, in Europe, there is a whole landscape of legislative developments surrounding data and data governance.

It is worthwhile looking at three of these proposals for developments more carefully – the Data Governance Act, the Data Act, and the shortly to be published European Health Data Space Act.

Several of these proposals for acts are for what are called Regulations. Being a Regulation means that, once the legislative texts are agreed and adopted, they will be immediately transposable into all the European Member States simultaneously. Regulations can, however, be adopted through a range of legislative procedures. There is usually an agreed time-period between the official publication of a Regulation and the date on which Member States must begin to apply its rules and procedures (e.g., 12 months, 18 months).

Europe’s commitments converge in three EU planned pieces of legislation

There is currently a convergence of approaches in Europe between three pieces of legislation, both planned and in the pipeline. These are the Data Act proposal released on 23 February 2022; the 2021 Data Governance Act which is still in the process of discussion between the European Council and the European Parliament; and the underpinning work of the European (Health) Data Space which is due to be launched imminently in 2022.

Other useful proposed acts include the Digital Markets Act and the Digital Services Act, and the April 2021-proposed AI Act on artificial intelligence.

Proposal for a Data Governance Act

In late 2021, the EU publicly announced the content of its Data Governance Act. Important aspects of governance in this proposed legislation relate to expected initiatives around good data management and data-sharing; better public sector policy development, transparency, and increased efficiency of public services; and data-driven innovation. The act aims at setting up solid mechanisms to facilitate the reuse of certain categories of protected public-sector data, increase trust in data intermediation services and promote data altruism across the EU.

Four mechanisms/measures are at the core of the act: they are intended to boost the development of trustworthy data-sharing.

As a result, trustworthy data-sharing would:

• Facilitate the re-use of public sector data that, today, is not available as open data.
• Ensure that data intermediaries act as trustworthy organisers of data-sharing or data polling.
• Ease data being made available by citizens and businesses for societal benefit.
• Facilitate data-sharing to be accessed across sectors and borders.

A European Data Innovation Board (a governing body) will be set up. The Board will have five key tasks (Article 27 (a) to (e), pp38-39) that include, among other activities, to advise and assist the Commission in enhancing the interoperability of data intermediation services and ensuring consistent practice in processing requests for public-sector data, among other tasks.”

Proposal for a Data Act:

On 23 February 2022, the European Commission released its proposal for a Data Act. The focus of the proposed act is on developing a Fair and Innovative Data Economy in Europe.

How to build a fair and innovative data economy has been a topic explored in-depth by EHTEL together with Finland’s innovation fund, SITRA, in several recent EHTEL Symposia (2019, 2020, and 2021).

Today, data is often located in individual silos. This act should provide a major contribution towards the extraction of data from stand-alone silos. Its proposed rules lay out precisely who can use and access data that is being generated across the EU in a wide variety of economic sectors.

Explicit references to health and care, however, are located only in the introductory section of the proposed act (known as the ‘Whereas’ section): one example is that of public emergencies. Much more specific guidance about health-related data is to be expected in the upcoming Health Data Space Act.

Proposal for a Health Data Space Act

The European Union’s first sectoral legislation on data spaces, specifically on the (European) Health Data Space, is due to be announced shortly, with a likely date of early May 2022.

The intended goals of the proposed act will be “to make the healthcare sector more efficient and advance scientific research in the telehealth area, and ‘unleash the health data economy’, fostering the development of new digital health services and products.”

In advance of its public announcement, policies that underpin the (European) Health Data Space are reported to include those which:

• Outline individuals’ rights on the ‘primary’ use of health care data.
  Concretely, European citizens would have electronic access to a minimum set of ‘primary’ health data i.e., vaccinations, electronic prescriptions, digital images, laboratory results, and reports on a patient’s discharge from clinical settings. Citizens would also be able to use an electronic access service that is “free of charge”.
• Influence ‘secondary’ use (re-use) of data in scientific fields (e.g., offer support to personalised medicines as a whole).
  The act will state what kinds of re-use of data are permitted, and identify precisely what types of re-use are forbidden. It will also offer details on how to implement “data altruism”.
• Set up a European Digital and Health Data Board (for governance purposes).
  The Board’s role will be to “support and advise the Commission on developing the labelling, certification and data quality guidelines and requirements”.
• Create both a health data infrastructure and a mandatory certification scheme.
  The scheme’s set of requirements will include the interoperability and security conditions that electronic health record systems will need to respect.

How does EHTEL see these developments?

Given the current state of play, therefore, EHTEL and its members look forward eagerly to the content of the last of these three acts, in particular to the proposed 2022 legislative act on the (European) Health Data Space.

EHTEL believes that this act will have much to offer to Europe’s citizens and businesses in terms of the positive use and re-use of health data as well as governance and standardisation/certification. EHTEL also anticipates that more clarity will come soon on the effects that the act will have on more over-arching and coherent pan-European approaches and/or on the subsidiarity of individual European Member States. Presumably too, there will be much more independence and autonomy to be seen on the part of individual European citizens.