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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European Health Data Space: Council and Parliament strike deal

(1 days ago) WebOn 3 May 2022 the European Commission published a proposal for a regulation creating a European Health Data Space (EHDS). The proposal is the first of …

https://www.consilium.europa.eu/en/press/press-releases/2024/03/15/european-health-data-space-council-and-parliament-strike-provisional-deal/

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EU Digital COVID Certificate - European Commission

(4 days ago) WebThe EU Digital COVID Certificate Regulation entered into application on 1 July 2021 and expired on 30 June 2023. A step towards global health security. On 1 July …

https://commission.europa.eu/strategy-and-policy/coronavirus-response/safe-covid-19-vaccines-europeans/eu-digital-covid-certificate_en

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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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Countries in the European Region adopt first-ever digital health …

(4 days ago) WebРусский. Deutsch. Health ministers and delegates from WHO/Europe’s 53 Member States have adopted the Region’s first-ever digital health action plan – an …

https://www.who.int/europe/news/item/13-09-2022-countries-in-the-european-region-adopt-first-ever-digital-health-action-plan

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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 …

https://digitalhealtheurope.eu/

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The rise of digital health technologies during the pandemic

(Just Now) WebThe market is expected to grow to US$218.5 billion by 2025. According to investment figures, healthtech start-ups are attracting new users and investment. It is estimated that …

https://www.europarl.europa.eu/RegData/etudes/BRIE/2021/690548/EPRS_BRI(2021)690548_EN.pdf

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The European Commission and WHO launch landmark digital …

(1 days ago) WebThe World Health Organization (WHO) and European Commission have announced today the launch of a landmark digital health partnership. In June 2023, …

https://www.who.int/news/item/05-06-2023-the-european-commission-and-who-launch-landmark-digital-health-initiative-to-strengthen-global-health-security

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Regulation of Digital Health Technologies in the European Union

(9 days ago) Web8.2 The EU Medical Devices Regulation . Medical devices are recognized as essential to the health and wellbeing of European citizens and legislation is essential to …

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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Digital Europe programme (2021–2027) EUR-Lex

(Just Now) WebMAIN DOCUMENT Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and …

https://eur-lex.europa.eu/EN/legal-content/summary/digital-europe-programme-2021-2027.html

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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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Towards harmonised EU Landscape for Digital Health

(2 days ago) WebA new element of the European digital health. In 2019, the German Digital Healthcare Act. (Digitale Versorgung-Gesetz) introduced a completely new approach to market access …

https://eithealth.eu/wp-content/uploads/2023/01/EIT_Health_DiGA_report_Jan2023.pdf

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New EU assessment framework for digital health on the horizon?

(3 days ago) WebHealth technology assessment (HTA) is a formidable task across drug development, medical device innovation, and digital health solutions. To help with this …

https://www.healthcareitnews.com/news/emea/new-eu-assessment-framework-digital-health-horizon

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Regulation on Health Technology Assessment - European …

(9 days ago) WebThe Regulation (EU) 2021/2282 on health technology assessment (HTAR) contributes to improving the availability for EU patients of innovative technologies in the area of health, …

https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment_en

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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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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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EU Digital Health competition - International Trade Administration

(1 days ago) WebNew laws, rules and regulations are being applied to companies, products and services in the digital and health industries. More pieces of legislation are under development. The …

https://www.trade.gov/eu-digital-health-competition

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DTx: where do EU regulations stand in this emerging, rapidly …

(8 days ago) WebDigital Therapeutics (DTx) are a new kind of medical device (some even say of medicine), designed to complement, lighten or even replace the need for medication. …

https://www.ibanet.org/digital-therapeutics-eu-regulations

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