Eu Digital Health Regulations

Listing Websites about Eu Digital Health Regulations

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eHealth : Digital health and care - European Commission

(2 days ago) WEBThe European Health Data Space is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework that aims at COVID-19 The European Commission and the EU countries have defined a …

https://health.ec.europa.eu/ehealth-digital-health-and-care_en

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DigitalHealthEurope

(1 days ago) WEBDigitalHealthEurope will provide comprehensive support to the Digital Health and Care Innovation initiative in the context of the Digital Single Market Strategy.The project’s approach involves a number of actions …

https://digitalhealtheurope.eu/

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Regulation of Digital Health Technologies in the European Union

(9 days ago) WEB40 See European Commission, Assessing the Impact of Digital Transformation of Health Services (2018); see also World Health Org., Draft global strategy on digital health …

https://www.cambridge.org/core/books/future-of-medical-device-regulation/regulation-of-digital-health-technologies-in-the-european-union/D1C211DD82EAEAD44511508B781F5C63

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DigitalHealthEurope recommendations on the European …

(1 days ago) WEB4.3 Establish a European Digital Health Hub 13 4.4 Scale up research and innovation to advance Europe’s digital capacity for clinical research 13 ANNEX: DHE Consultations …

https://digitalhealtheurope.eu/wp-content/uploads/DHE_recommendations_on_EHDS_July_2021.pdf

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Evolving regulatory perspectives on digital health - Nature

(Just Now) WEBDigital health technology tools (DHTTs) present real opportunities for accelerating innovation, improving patient care, reducing clinical trial duration and …

https://www.nature.com/articles/s41746-023-00790-2

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Exchange of electronic health records across the EU

(5 days ago) WEBThe first exchanges took place between Estonia and Finland in January 2019. Twenty-two EU countries are expected to exchange such health information by 2021. This …

https://digital-strategy.ec.europa.eu/en/policies/electronic-health-records

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Understanding Digital Health Regulations in the EU - LinkedIn

(6 days ago) WEBIn the dynamic realm of digital health, the European Union (EU) plays a central role in shaping the regulatory framework that governs the development, …

https://www.linkedin.com/pulse/understanding-digital-health-regulations-eu-navigating-khan-10b0f

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POLICY BRIEF - Use of digital health tools in Europe

(5 days ago) WEBDigital health technologies hold the potential to bring about major improvements in the efficiency of health systems, both in terms of care provision and the administration of the system as a whole. After all, in …

https://www.ncbi.nlm.nih.gov/books/NBK576973/

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Digital health: a European legal framework Simmons & Simmons

(5 days ago) WEBOn an EU level, the Digital health’s legal environment is very diverse: (E-Commerce), Regulation (EU) 2014/910 (electronic identification and trust services for …

https://www.simmons-simmons.com/en/publications/ckpzd2qes1c7l0968v55dor5l/digital-health-a-european-legal-framework

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In brief: digital healthcare in European Union - Lexology

(3 days ago) WEBIn terms of patients’ privacy, the legal framework ensuring digital privacy for EU citizens has recently been amended by Regulation 2016/679 on the protection of …

https://www.lexology.com/library/detail.aspx?g=2498a288-818f-44d5-a542-308d932c9786

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Digital Health Laws and Regulations Germany 2024

(5 days ago) WEBThe GPSD will be replaced by the General Product Safety Regulation (EU) 2023/988 (“GPSR”) from 13 December 2024. In the digital health sector, however, the …

https://iclg.com/practice-areas/digital-health-laws-and-regulations/germany

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Editorial – Digital healthcare regulation: paving the way for

(4 days ago) WEBThe European artificial intelligence strategy: implications and challenges for digital health. Lancet Digital Health 2020; 2: e376–e379. 6 Matheny M, Thadaney Israni S, Ahmed M, …

https://thinktank.eithealth.eu/legal-office/editorial-digital-healthcare-regulation/

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Digital Health - EFPIA

(7 days ago) WEBDigital health is a broad term that encompasses a variety of terms including e-health, m-health and telehealth and captures everything from electronic patient records, remote …

https://www.efpia.eu/about-medicines/development-of-medicines/digital-health/

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Reflection Paper on regulatory frameworks for digital health

(4 days ago) WEB05 Apr 2019. Reflection Paper on regulatory frameworks for digital health technologies in Europe. DIGITALEUROPE has developed this reflection paper on how the entry criteria …

https://www.digitaleurope.org/resources/reflection-paper-on-regulatory-frameworks-for-digital-health-technologies-in-europe/

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EU regulation: AI Act will mean a raft of new requirements for …

(8 days ago) WEBHigh-risk AI systems. Under the Act, any AI system that is a Class IIa (or higher) medical device, or uses an AI system as a safety component, is designated as …

https://www.digitalhealth.net/2024/04/eu-regulation-ai-act-will-mean-a-raft-of-new-requirements-for-high-risk-systems/

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Digital Health - PGEU

(5 days ago) WEBThe European Commission will publish its proposals in the 4 th quarter of 2020. The new Digital Services Act package is expected to modernise the current legal framework for …

https://www.pgeu.eu/digital-health/

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Regulatory Guidance Digital Health

(3 days ago) WEBAs digital health continues to hold an important place in modern healthcare, it is critical to ensure the safety and efficacy of digital health-related solutions (from devices, …

https://digital.health/regulatory

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Europe fit for the Digital Age: new online rules for platforms

(6 days ago) WEBWhat the new Digital Services Act changes: Ensure that small online platforms are not disproportionately affected but they remain accountable. Small and micro-enterprises …

https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/europe-fit-digital-age/digital-services-act/europe-fit-digital-age-new-online-rules-platforms_en

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European Digital Compliance: Key Digital Regulation

(7 days ago) WEBTo help organizations stay on top of the main developments in European digital compliance, Morrison Foerster’s European Digital Regulatory Compliance team …

https://www.mofo.com/resources/insights/240430-european-digital-compliance-key-digital-regulation

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