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Berichten met de tag eHealth
Suzan Slijpen Conference Speaker at the National University of Ireland
Suzan Slijpen Conference Speaker at the National University of Ireland

Legal Aspects of AI in Healthcare

On 16 August 2019, Suzan Slijpen LL.M. had the honour to speak about the legal aspects of the development and use of artificial intelligence (a disruptive technology) in healthcare, at the AI in Medicine Conference organized by the Irish Association of Physicists in Medicine (IAPM). The conference took place in Galway, at the National University of Ireland (School of Physics, NUI Galway/ OÉ Gaillimh). Suzan is a senior legal consultant at AIRecht.nl, and specializes in eHealth & medical devices, pharmaceutical law, European food law and contract law, from an AI helicopterview. She is also founder and lawyer at boutique law office Slijpen Legal.

Key topics of the Artificial Intelligence in Medicine lecture

Key legal topics that Suzan addressed in her Artificial Intelligence in Medicine lecture:

1. AI & Robotics: Disruptive Technologies: Synergetic effects of 4th Industrial Revolution technologies like robotics, big data, quantum computing, Blockchain, Virtual Reality (VR) and Internet of Things (IoT).

2. eHealth and medical devices: legal classification.

3. Fundamental Rights: Safeguarding of Fundamental Rights in AI applications, Rights of Patients.

4. Ethics and responsible AI: 1791 French Revolution Values, HLEG Concept of Trustworthy AI.

5. Intellectual Property on AI and Health Apps: Licensing your IP.

6. Liability for damages caused by smart robots: who is liable for misdiagnosis by an AI algorithm?

7. Legislation and Jurisprudence.

8. AI Impact Assessment: remove roadblocks for AI.

Legislation and regulations regarding AI in Healthcare

Do you want to know more about legislation and regulations regarding AI in Healthcare, or Legal aspects of disruptive tech in Medicine? Or do you want to organize a workshop or conference yourself and invite us as a speaker or teacher? Then please contact us about the possibilities!

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What are the main requirements for AI systems in Healthcare?
What are the main requirements for AI systems in Healthcare?

Main barriers to adoptation of Artificial Intelligence in healthcare.

Absence of a specific AI law, or clear legal framework from the perspective of both professional users (A) and patients (B).

When constructing such a framework, it is important to make a distinction between the various sub-areas of healthcare, such as research and development, professional care providers and recipients of care. Because each sub-area has different needs.

Barriers for professional users.

It is simply unclear for companies and private and academic research institutes in the medical sector what is and is not allowed in the field of AI, blockchain, computer & machine vision and robotics. Both at European level and at national level. This knowledge is important for the commodification of their inventions/creations. Two practical examples are permission from Farmatec and obtaining a CE-marking.

Requirements for sustained use of AI in healthcare.

Since traceability and transparency are key within any healthcare (and food-feed) system, blockchain could play an important role in sustained use of AI in healthcare.

A EU AI Directive or Regulation should be able to implement and/or adhere to principles of Eudralex (The body of European Union legislation in the pharmaceutical sector), Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) in particular.

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Algoritmes, Artificiële Intelligentie, AVG / GDPR, Big data, Blockchain, Cognitive Computing, Computer Vision, Deep Learning, Europees recht, Europese Richtlijn, Ethiek, Farmaceutica, Grondrechten, Kunstmatige Intelligentie, Machine Learning, Privacywetgeving, Productontwikkeling, Robotica, Robotlaw, Tech Startups, Virtual Reality, Wetgeving, Healthcare, eHealth, Medical DevicesMauritz KopArtificiële Intelligentie & Rechthealthcare, Artificial Intelligence Impact Assessment, robotics, blockchain, intellectual property, insurance, liability, damages, AI, Farmatec, FDA, QAQC-systems, GMP, GDP, medicine, Eudralex, Medical Devices, eHealth, wearables, legislation, European Union, European AI Alliance, privacy, legal and ethical framework, CE-marking, pilots, computer vision, machine learning, virtual reality, Law School, Medical School, fundamental rights, copyrights, computer generated works, regulation, directive, Machinery, standards, path dependency, traceability, surgery, patients, big data, cognitive computing, knowledge, legal certainty, innovation, tech startups, incentive & reward