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Healthtech Source Booklet:
Regulatory and policy developments
2026 Edition

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Healthtech, medtech, pharmatech, biotech, agetech, vettech
1. Research conducted by individuals, companies, associations and universities
1.1. January
1.1.1. International

  • World Economic Forum (WEF) & McKinsey Health Institute, The Human Advantage: Stronger Brains in the Age of AI, Janaury 2026, accessible here;

1.1.2. Asia

1.1.2.1. United Arab Emirates​

  • World Economic Forum (WEF) & Department of Health Abu Dhabi, A New Era for Digital Health: Abu Dhabi’s Leap to Health Intelligence, January 2026, accessible here; 

1.2. February

1.2.1. International​

  • Michelle Mello et al., Toward Responsible AI in Health Insurance Decision-Making, Stanford University, Stanford Institute for Human-Centered Artificial Intelligence (HAI), February 2026, accessible here;

1.3. March
1.3.1. International​

  • ​The Royal College of Radiologists (RCR), Post-deployment monitoring and safety reporting of AI medical imaging devices in clinical practice, March 2026, accessible here; 

1.6. June

1.6.1. International​

  • World Economic Forum (WEF) & LSE Health, Meaningful Outcomes Determine the Winners of the Health AI Race, June 2026, accessible here; 

2. Reports, guidelines, recommendations and other documents published by regulatory and supervisory authorities, international organizations, and other public institutions and agencies

2.1. January

2.1.1. Europe

2.1.1.1. European Union​

  • Olivier le Blanc et al., Observatory for digital health technologies in Europe - Exploring Europe’s Digital Health Landscape: Market Dynamics and Economic Impact - Final Report, Capgemini Invent, IDC, European Commission, DG Communications, Networks, Content and Technology (CNECT), CNECT/2022/OP/0036, January 2026, accessible here; 

2.2. February

2.2.1. Europe

2.2.1.1. European Union

  • Milena Mennecozzi, Monica Piergiovanni & Lucia Selfa Aspiroz, PhD & Maurice Whelan, Strengthening the competitiveness of EU in vitro biotechnologies, European Commission, Joint Research Centre (JRC), Elsevier Science, JRC141680, February 2026, accessible here, here & here; 

2.3. March

2.3.1. International​

  • Pan American Health Organization (PAHO), Bias-free artificial intelligence in health - Dos and don’ts for developing and implementing algorithms, World Health Organization (WHO), March 2026, accessible here;

  • Isaura Gutiérrez Vargas & Eric Sutherland, Building people-centred digital health systems - Lessons from PaRIS, Organisation for Economic Co-operation and Developmen (OECD), March 2026, accessible here; 

  • World Health Organization (WHO), Equity across the regulation, implementation and evaluation of digital health: scoping review, March 2026, accessible here; 

2.3.2. Europe
2.3.2.1. European Union​

  • CNIL - Commission Nationale de l'Informatique et des Libertés, IA et santé: développer et évaluer des systèmes d’IA en conformité avec la réglementation - La CNIL a accompagné plusieurs projets de développement ou d’évaluation de systèmes d’intelligence artificielle (IA) destinés au secteur de la santé. Quelle est la procédure applicable et quelles sont les précautions à prendre? ("AI and health: develop and evaluate regulatory AI systems - The CNIL has accompanied several projects for the development or evaluation of Artificial intelligence (IA) for the health sector. What is the applicable procedure and what are the precautions to be taken?"), March 2026, accessible here; 

  • Susana Nascimento et al., ERC Frontier Research for Artificial Intelligence in Health - From disease prevention to diagnosis and treatment, European Research Council (ERC), European Commission, Publications Office of the European Union, March 2026, accessible here; 

  • European Data Protection Board (EDPB) & European Data Protection Supervisor (EDPS), EDPB-EDPS Joint Opinion 3/2026 On the Proposal for a Regulation on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health (European Biotech Act), March 2026, accessible here; 

  • European Commission, Frequently Asked Questions on the European Health Data Space - Last updated 26th of March 2026, Directorate-General for Health & Food Safety (DG SANTE), Unit C.1 – Digital Health, March 2026, accessible here;

  • Laurence Amand Eeckhout, Medical devices: Simplifying the rules, European Parliament, European Parliamentary Research Service (EPRS), PE 785.663, March 2026, accessible here; 

  • Ambra Maddalon et al., Putting Science into Standards – 3D Bioprinting: Towards Standards in Biomedicine, European Commission, Joint Research Centre (JRC), Publications Office of the European Union, JRC145664, March 2026, accessible here;

  • European Data Protection Board (EDPB) & European Data Protection Supervisor (EDPS), EDPB-EDPS Joint Opinion 3/2026 On the Proposal for a Regulation on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health (European Biotech Act), March 2026, accessible here; 

2.3.3. North America

2.3.3.1. Canada​

  • Office of the Information and Privacy Commissioner for British Columbia, PIPA and Al scribes: best practices for healthcare organizations in ВС, January 2026, accessible here; 

  • Information and Privacy Commissioner of Ontario, AI Scribes: Key Considerations for the Health Sector, January 2026, accessible here; 

2.4. April

2.4.1. International​

  • World Health Organization (WHO), Artificial intelligence is reshaping health systems: state of readiness across the European Union, WHO Regional Office for Europe, Data and Digital Health (DDH), Division of Country Health Policies and Systems (CPS), April 2026, accessible here;

  • World Health Organization (WHO), Artificial intelligence and evidence-informed policy: emerging challenges and opportunities: discussion paper, April 2026, accessible here;

  • United Nations Educational, Scientific and Cultural Organization (UNESCO), Ethical considerations for youth mental health in the digital environment, International Bioethics Committee of UNESCO (IBC), April 2026, accessible here; 

  • Jon Frost, Jermy Prenio, Vatsala Shreeti & David Symington, Digitalisation and innovation – opportunities and risks for financial health, Bank for International Settlements (BIS), Financial Stability Institute (FSI), United Nations Secretary-General's Special Advocate for Financial Health (UNSGSA), April 2026, accessible here; 

2.4.2. Europe

2.4.2.1. European Union

  • Pierre Deceuninck et al., Leveraging Artificial Intelligence tools to collect and structure information on human biology-based models used in biomedical research, European Commission, Joint Research Centre (JRC), JRC144237, Publications Office of the European Union, April 2026, accessible here;

  • Valentin Comte et al., Artificial Intelligence in Cardiovascular Care, European Commission, Joint Research Centre (JRC), JRC146049, Publications Office of the European Union, April 2026, accessible here; 

  • Cosima Lenz, Petra Varkonyi, & Marta Dell'Aquila, Patient-centred health research and innovation in the EU - A preliminary exploratory study, Policy Department for Transformation, Innovation and Health, Directorate-General for Economy, Transformation and Industry (DG ECTI), PE 786.414, April 2026, accessible here; 

  • Laurence Amand Eeckhout, European biotech act, European Parliament, European Parliamentary Research Service (EPRS), PE 785.708, April 2026, accessible here; 

2.5. May

2.5.1. International​

  • World Health Organization (WHO), Integrating wearable technology into population health monitoring systems for physical activity measurement: meeting report, 25–27 November 2025, Utrecht, Kingdom of the Netherlands, May 2026, accessible here; 

2.5.2. Europe

2.5.2.1. European Union​

  • European Commission, The impact of Artificial Intelligence on our societies, Independent Expert Report, Directorate-General for Research and Innovation (DG RTD), Directorate D — People: Health and Society, May 2026, accessible here; 

  • Laurence Amand Eeckhout, Health and wellbeing in the age of artificial intelligence, European Parliament, European Parliamentary Research Service (EPRS), PE 785.741, May 2026, accessible here; 

2.6. June
2.6.1. International

  • Miriam Aczel et al., The Environmental Cost of Artificial Intelligence: Carbon, Water, and Land Footprints, United Nations University Institute for Water, Environment and Health (UNU-INWEH), Government of Canada, June 2026, accessible here;

  • World Health Organization (WHO), Digital transformation handbook for reporting substandard and falsified medical products, June 2026, accessible here;   

2.6.2. Europe

2.6.2.1. European Union​

  • ​European Commission, 2026 Digital Decade eHealth Indicator Study, Capgemini, CNECT/2022/OP/0036, June 2026, accessible  here; 

  • Anne-Marie Finnemann and Victoria Valledor de Vicente, Digital Health: Preparing Healthcare Systems for the Future, European Parliament, European Parliamentary Research Service (EPRS), PE 786.418, June 2026, accessible here;

  • Tiemo Wölken, Draft Opinion of the Committee on Legal Affairs for the Committee on Public Health and the Committee on Industry, Research and Energy on the proposal for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act), COM(2025)1022 – C10-0363/2025 – 2025/0406(COD), European Parliament, June 2026, accessible here; 

  • Maria Guzenina, Draft opinion of the Committee on the Internal Market and Consumer Protection for the Committee on Public Health on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I, COM(2025)1023 – C10-0360/2025 – 2025/0404(COD), European Parliament, Committee on the Internal Market and Consumer Protection, June 2026, accessible here; 

  • Vytenis Povilas Andriukaitis & Wouter Beke, Draft report on the proposal for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act), COM(2025)1022 – C10-0363/2025 – 2025/0406(COD), European Parliament, Committee on Public Health, Committee on Industry, Research and Energy, June 2026, accessible here; 

2.7. July
2.7.1. International

  • International Telecommunication Union (ITU), World Health Organization (WHO) & World Intellectual Property Organization (WIPO), AI-enabled Health Innovation and IP - From idea to impact, July 2026, accessible here; 

  • World Health Organization (WHO), International Telecommunication Union (ITU) & World Intellectual Property Organization (WIPO), Mapping the application of artificial intelligence in traditional medicine, July 2026, accessible here; 

2.7.2. Europe

2.7.2.1. European Union​

  • Sergio Consoli et al., Recent Advancements on Artificial Intelligence for Public Health Threats - The Digital Health Perspectives, European Commission, Joint Research Centre (JRC), JRC142475, Publications Office of the European Union, July 2026, accessible here; 

  • European Union Agency for Cybersecurity (ENISA), Procurement guidelines for the cybersecurity of hospitals and healthcare providers, July 2026, accessible here; 

  • European Parliament, Mental health of young people in a digital era - Cost of non-Europe report, European Parliamentary Research Service (EPRS), European Added Value Unit, PE 774.672, July 2026, accessible here; 

  • Monica Carlotti, Serenella Sala & Teresa Lettieri, Environmental Biotechnology for a Sustainable and Competitive EU - Strengthening strategic autonomy, resilience and resource security, European Commission, Joint Research Centre (JRC), JRC147778, Publications Office of the European Union, July 2026, accessible here;

2.8. August

2.8.1. Europe
2.8.1.1. European Union

  • Anne-Marie Finnemann & Ioana-Alice Postu, Medicines and Medical Devices, EU Fact Sheets, European Parliament, August 2026, accessible here; 

  • Victoria Ruiz Serra et al., Artificial Intelligence for Biology: Capabilities, Readiness, and Policy Implications, European Commission, Joint Research Centre (JRC), JRC147549, Publications Office of the European Union, August 2026, accessible here;

  • Sara Banfi et al., Cleantech Innovation, Industrial Decarbonisation and Global Competition - Where does the EU stand in the race towards net-zero compared to the US and China?, European Parliament, Directorate-General for Economy, Transformation and Industry (DG ECTI), Policy Department for Transformation, Innovation and Health, PE 790.564, August 2026, accessible here; 

2.8.2. North America

2.8.2.1. United States of America​

  • U.S. Food & Drug Administration (FDA), Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback, August 2026, accessible here; 

2.9. September

2.9.1. International

  • World Health Organization (WHO), Report of the Knowledge Community on responsible artificial intelligence in health - From promise to practice, September 2026, accessible here;

2.9.2. Europe

2.9.2.1. European Union

  • European Commission, Draft Commission Implementing Regulation on HealthData@EU, Ares(2026)8339104, September 2026, accessible here;

2.9.2.2. United Kingdom

  • National Commission into the Regulation of AI in Healthcare, National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework, September 2026, accessible here; 

​3. Legislations, regulations, other legislative instruments

3.1. April
3.1.1. Europe
3.1.1.1. European Union​

  • European Commission, Commission Implementing Regulation (EU) …/... of XXX laying down the minimum metadata elements and their characteristics to be provided by health data holders for dataset descriptions for the secondary use of electronic health data under Article 77(1) of Regulation (EU) 2025/327 establishing the European Health Data Space, Ref. Ares(2026)3843449, April 2026, accessible here​; 

4. Litigation & case-law

4.2. March

4.2.1. Europe

4.2.1.1. European Union​​

  • Court of Justice of the European Union (CJEU), A police authority may, in a criminal investigation, collect biometric data solely on the ground that that collection is strictly necessary, Judgment of the Court in Case C-371/24 | [Comdribus], March 2026, accessible here;

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