New Policy Updates on Digital Health in the EU: Major Milestones and Critical Policy Points for Artificial Intelligence in Health and Healthcare in the EU

An updated draft report[1] on artificial intelligence (AI) in the digital age was recently published by the Special Committee on Artificial Intelligence in a Digital Age (AIDA) of the European Parliament. The goal of the AIDA committee and this report is an urgent call to action: to create an appropriate framework for a safe and efficient proliferation of AI technology, primarily in health and healthcare.

The draft report builds on several actions already taking place at the EU level. The European Commission published its AI package in April 2021, proposing new rules and actions to turn Europe into the global hub for trustworthy AI. This package consisted of:

• a Communication on Fostering a European Approach to Artificial Intelligence;
• a Coordinated Plan with Member States: 2021 Update; and
• (most importantly) a proposal for an AI regulation laying down harmonized rules for the EU (Artificial Intelligence Act).

Needless to say, AI has enormous potential to improve almost every area of our lives[2], particularly in health and healthcare. The commission published the Artificial Intelligence in Healthcare report in November 2021, which aimed to map current AI policies in health and healthcare across the EU. The study found that while most EU member states have developed AI strategies that identify the healthcare sector as a priority, there are no policies within those strategies targeting healthcare specifically.

The proposed actions of the commission and the draft report presented by the AIDA committee, published on the 9th of November 2021, together forward the adoption of a common framework for the implementation of AI in health and healthcare at the EU level. The most critical points potentially affecting the drive for innovation discussed in the report: 

  1. Education

There is a need for multidisciplinary university curriculums that focus on digital and AI skills, primarily in health. The committee stresses the need for measures and incentives that enhance healthcare providers’ potential to promote the uptake of AI solutions.

  2. Funding & reimbursement

The committee urges the prioritization of funding, the setting of strategic goals, the fostering of cooperation and the adoption of AI applications in healthcare, which it puts forward as a critical sector. The report considers equitable access to healthcare as a principle that should be extended to health-related AI applications. This could indicate that applications may be reimbursed by our healthcare systems one day.

  3. Harmonized frameworks/platforms

The committee stresses the need for sector-specific but harmonized legislation for health data governance at the EU level and calls on the commission to support the setup and operation of a European health data space. Two points the committee emphasizes as priorities for assessment:

• A liability framework and harmonized approval processes

The committee calls for a clear liability framework and harmonized approval processes for AI-based medical applications and medicines developed or tested via AI and machine learning, and it urges the crafting of practical, best-practice regulations, standards and criteria to certify and approve healthcare applications in line with liability risks.

• A patient-centered approach and PROs integrated across the spectrum

The committee regards as important human-centered design and an evidence-based approach to AI in health that focuses on patient-oriented and high-quality digital healthcare and that seeks consumer and user feedback throughout the development process.

  4. Data protection

The committee calls on the European Commission to create a sector-specific chapter on health in the GDPR to ensure the processing of data for scientific purposes in healthcare and stresses the need to reduce the obligation for additional consent when using AI in medical research.

Education, funding, reimbursement schemes, EU-wide harmonized frameworks/platforms, and data protection criteria are the keywords I took from this piece of work of the EU Parliament. Something is moving forward and moving fast at the EU level for digital health and is very welcomed!

[1] https://www.axel-voss-europa.de/wp-content/uploads/2021/11/AVoss_AIDA-draft-report-full-version.pdf
[2] Artificial intelligence: huge potential if ethical risks are addressed | News | European Parliament (europa.eu)

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