Reading List Healthcare
Within health care, special personal data is processed very often. There are rules on how to handle these kinds of data and they still apply when data is processed with AI. However, there are also plans to use personal data more frequently for projects that do not benefit patients. On this page you will find an overview of the current laws and regulations that apply to personal data from healthcare and also reports that give an indication of possible developments.
LAWS AND REGULATIONS
IGJ review framework 'Deployment of e-health by healthcare providers' - Healthcare and Youth Inspectorate (IGJ), Ministry of Health, Welfare and Sport (2018)
Assessment frameworks deployment of e-health by healthcare providers
Handout legal and normative frameworks around AI in healthcare
An overview compiled at the request of the Ministry of Health, Welfare and Sport.
Handout legal and normative frameworks around AI in health care
Guide to AI in health care - Mr. M.F. van der Mersch (2020)
In her publication, attorney Van der Mersch discusses the laws and regulations for software containing AI using a fictitious real-life example. The guide answers legal questions that arise in practice.
Guide GDPR and AI – Dutch Ministry of Health, Welfare and Sport (2020)
The Dutch Ministry of VWS provides an overview of the rules that are already in place from the AVG that also apply when making AI.
REPORTS AND POLICY DOCUMENTS
Proposed Regulation for Artificial Intelligence - European Commission (2021) A proposed regulation providing a regulatory framework for the deployment of Artificial Intelligence.
Report Data solidarity for health - Points for improvement with an eye to everyone's interests - Gerritsen, J. and P. Verhoef, Rathenau Institute (2020) A report following a study on the use of digital data from medical records.
White paper on artificial intelligence - a European approach based on excellence and trust - European Commission (2020)
With this white paper and accompanying report on the security and liability framework, the Commission initiates a broad consultation in which it gauges from civil society, industry and academia concrete proposals for a European approach to Artificial Intelligence.
GDPR's impact on AI - European Parliament think tank (2020)
Research by the Research Service of the European Parliament shows that AVG and AI can coexist well. A comprehensive analysis shows that with the right application, data subjects are protected while at the same time using the useful applications of AI.
The impact of the General Data Protection Regulation (GDPR) on Artificial Intelligence
Comparative study on 'further use' of health data - Researchgate - European Journal of Human Genetics (2020)
Article in European Journal of Human Genetics
Guidance on Qualification and Classification of Software in Regulation (MDCG 2019-11) - European Commission (2019) This document provides guidance on the qualification and classification of software under the MDR and IVDR and is aimed primarily at medical software manufacturers. The guidelines also address the marketing and conformity assessment of medical device software.
https://ec.europa.eu/docsroom/documents/37581
Ethics Guidelines for trustworthy AI - AI HLEG European Commission (2019)
Guidelines prepared by an expert group commissioned by the European Commission on responsible AI use.
https://ec.europa.eu/newsroom/dae/document.cfm?doc_id=60419
Artificial Intelligence for Europe - European Commission (2018)
European strategy on AI.
https://eur-lex.europa.eu/legal-content/NL/TXT/?uri=CELEX%3A52018DC0237&qid=1618499054142
MORE INFORMATION:
https://www.datavoorgezondheid.nl/
https://www.rathenau.nl/nl/digitale-zorg
https://www.knmg.nl/advies-richtlijnen/dossiers/informed-consent.htm
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