Legal
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Articles (31)
7 April 2026 DPOs: how automated compliance cuts operational costs by 80%
With over EUR 4.5 billion in GDPR fines issued and the AI Act in force, DPOs need integrated tools. The numbers speak fo...
18 March 2026 EHDS towards 2027: Health Data Access Bodies, data permits and the build-out of European secondary use
One year after the EHDS Regulation entered into force: the state of preparedness for the first obligations (March 2027),...
15 March 2026 EU AI Act — what changes from August 2026
A clear overview of the new EU rules on artificial intelligence and what companies need to do before the deadline....
16 February 2026 Medical software and AI: the global state of certifications in 2026
Overview of software as a medical device certifications worldwide, spanning EU MDR, FDA, MHRA and the regulatory challen...
16 April 2025 European Health Data Space: Regulation (EU) 2025/327 and the new European health data frame
The European Health Data Space Regulation, published on 5 March 2025 and in force from 26 March 2025. Primary use, secon...
20 September 2024 FSE Gateway and Decree of 7 September 2023: the operational architecture of Italian FSE 2.0
The Ministry of Health Decree of 7 September 2023 implementing Article 12 paragraph 15-quater of DL 179/2012, the new na...
24 May 2022 PNRR Mission 6 and FSE 2.0: €1.38 billion for the second generation of the Italian EHR
Italy's National Recovery and Resilience Plan earmarks €1.38 billion for the evolution of the Electronic Health Record. ...
15 November 2018 MDR: the EU Medical Device Regulation and the Class I certification path
Deep dive on MDR Regulation 2017/745, comparison with the former MDD Directive 93/42/EEC, and noze's experience certifyi...
23 May 2018 GDPR and health data: Article 9 and the boundaries of processing
Regulation (EU) 2016/679 applies from 25 May 2018: definitions of health data, special categories, Article 9 derogations...
14 December 2015 DPCM 178/2015: technical rules for the Italian Electronic Health Record
DPCM 29 September 2015, no. 178 implements Article 12 of DL 179/2012 and governs the Italian Electronic Health Record (F...
28 November 2012 Italian Electronic Health Record: Decree-Law 179/2012, Article 12, and the legal birth of the FSE
Decree-Law 179/2012 and Article 12: the first unified legal framework for the Italian Electronic Health Record (FSE). Pu...
19 November 2010 Substitute Preservation
Substitute preservation: electronic document, qualified electronic signature, time stamp, art. 22-23 CAD, DPCM 13/01/200...