Category: News

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Proposal for a Regulation on European data governance (Data Governance Act)

The proposed regulation includes several measures to increase trust in data sharing, rules on neutrality to allow “novel data intermediaries” to function as safe data-sharing organizers, and practices to give Europeans more control over how their data is used. The commission also published a frequently asked question page to coincide with the announcement.

The proposal is the first of a set of measures announced in the 2020 European strategy for data. The instrument aims to foster the availability of data for use by increasing trust in data intermediaries and by strengthening data-sharing mechanisms across the EU.

Overview page with links etc.:
https://ec.europa.eu/commission/presscorner/detail/en/ip_20_2102

Draft in English:
https://ec.europa.eu/newsroom/dae/document.cfm?action=display&doc_id=71222

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Germany: Referentenentwurf DVMPG

Draft for new German law to modernize health care
(Digitale Versorgung und Pflege – Modernisierungs-Gesetz – DVPMG)

This includes important changes to DIGAV!
(See “Artikel 8”, page 44ff)

  • From 1.Jan 2023 DIGA (digital health applications) would need to be able to export data into a the electronic patient file (elektronische Patientenakte)
  • Also new requirements on certified information security management (from no later than 1 Jan 2022) and a BSI certificate on data security (from 1 Jan 2023). This also applies to digital health applications which are already registered.
  • Also new requirements on integrating with the electronic patient card for authentication (elektronische Gesundheitskarte) – unless the DIGA is purely web-based. (31 Dec 2020)
  • Also the vendor needs to ensure that the provided health information is kept up-to-date.

https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/Gesetze_und_Verordnungen/GuV/D/Referentenentwurf_DVPMG.pdf

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EDPB and SchremsII

Final version at https://edpb.europa.eu/system/files/2021-06/edpb_recommendations_202001vo.2.0_supplementarymeasurestransferstools_en.pdf
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https://edpb.europa.eu/sites/edpb/files/consultation/edpb_recommendations_202001_supplementarymeasurestransferstools_en.pdf
https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_recommendations_202002_europeanessentialguaranteessurveillance_en.pdf

https://iapp.org/news/a/a-break-down-of-edpbs-recommendations-for-data-transfers-post-schrems-ii/

https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_plenaryminutes_38_20200914_public.pdf