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New Guidance Published on Cybersecurity and Medical Devices

Data Matters

New European medical device guidance will require manufacturers to carefully review cybersecurity and IT security requirements in relation to their devices and in their product literature. The Guidance acknowledges that even though the Regulations impose legal obligations only on the manufacturer of the device, all other actors (e.g.,

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Hunton Releases 2016 EU General Data Protection Regulation Guide for In-House Lawyers

Hunton Privacy

After much debate, the final version of the EU General Data Protection Regulation (“GDPR”) is expected to be adopted by the European Parliament this week and to take effect in early 2018. enforcement, sanctions and penalties. supervisory authorities. accountability. privacy by design and by default. data breach reporting.

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EUROPE: EU MDGC issues new guidance on Cybersecurity for medical devices

DLA Piper Privacy Matters

On 7 January 2020, the EU Medical Device Coordination Group published new guidance to help manufacturers fulfil all relevant cybersecurity requirements in Annex I to the new Medical Device Regulations (Regulations 2017/745 on medical devices and 2017/746 on in vitro diagnostic medical devices) (the Guidelines).

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EU Commission Issues Draft AI Regulation

Data Matters

Companies engaged in the development, manufacturing, importation, distribution, servicing, and use of AI – irrespective of industry – should assess to what extent their products are implicated and how they will address any regulatory requirements they are subject to. Who Does the Draft AI Regulation Apply to?

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AUSTRALIA: Assistance and Access Act, December 2018 – Holy grail of uncertainty created by new rushed-in data encryption laws

DLA Piper Privacy Matters

The scope of access provided for in the Act is modelled on, and appears to have taken lesson from, the similarly focused UK Investigatory Powers Act 2016 (the UK Act ), which, earlier in 2018, was found to be inconsistent with European Union law by the UK High Court.

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Article 29 Working Party and EDPS Release Opinions on the ePrivacy Directive

Hunton Privacy

On July 25, 2016, the Article 29 Working Party (the “Working Party”) and the European Data Protection Supervisor (“EDPS”) released their respective Opinions regarding the review of Directive 2002/58/EC on privacy and electronic communications (the “ePrivacy Directive”). Enforcement.

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SER’s growth double that of ECM market competition

Info Source

compared to 2016. SER is a pioneer when it comes to security: Already in 2017, the renowned auditing firm Ebner Stolz certified Doxis4 according to the EU General Data Protection Regulation (GDPR). more than in 2016. The strong revenue figure equates to a significant growth increase of 9.4% Pioneer in security.

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