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Smart & Biggar | Canada | 7 Jun 2023
Health Canada proposes amendments to Medical Devices Regulations to address future public health emergencies
Health Canada has proposed amendments to the Medical Devices Regulations that would expand the regulatory framework for covid-19 medical devices to apply to future public health emergencies. Under the proposed amendments, part 1.1 of the regulations would no longer be specific to covid-19 medical devices. Instead, part 1.1 would apply to medical devices that have an urgent public health need......
Lexology PRO | Belgium, China, European Union, etc. | 30 May 2023
Data protection: key compliance updates (22 – 30 May)
90 UK organisations report data breaches after Capita cyberattack, TikTok is suing the US state of Montana as the app faces a ban, and Twitter leaves the EU voluntary code on disinformation – plus other key updates.
Lexology PRO | Japan | 25 May 2023
Japan raids healthcare software provider
Japan’s competition authority has raided a healthcare technology company over concerns it forced payment providers to sell its software if they wanted to connect with its platform.
Lexology PRO | USA | 24 May 2023
FTC to expand Health Breach Notification Rule
Proposed amendments to the Health Breach Notification Rule could strengthen a measure that has recently become a go-to enforcement tool in Federal Trade Commission health data cases.
Lexology PRO | Brazil, Central & South America | 11 May 2023
Brazil blocks health insurance tie-up over duopoly concerns
Brazil’s competition authority has blocked Hapvida’s €54 million acquisition of rival health plan provider Smile to prevent just two companies controlling nearly 90% of the health insurance market in northeastern Brazil.
Baker McKenzie | USA | 10 May 2023
FDA issues guidance on predetermined change control plans for AI/ML-enabled device software functions
The Food and Drug Administration (FDA) recently issued draft guidance for manufacturers whose medical devices use machine learning (ML) technologies to improve patient care. Through the draft guidance, the FDA intends to provide a least burdensome approach to support iterative improvements to ML-enabled device software functions through modifications, while continuing to provide a reasonable......
Lexology PRO | European Union, Global, Italy, etc. | 2 May 2023
Data protection: key compliance updates (24 April – 2 May)
Wikipedia refuses to conduct UK Online Safety Bill age checks, the Italian DPA lifts its ban on ChatGPT, and nineteen companies including Google and TikTok face extra rules under the EU DSA – plus other key updates.
Lexology PRO | Brazil | 28 Apr 2023
Brazil reaches second €10 million settlement in pacemaker cartel probe
International medical technology company Biotronik Comercial Médica has admitted to its role in a cartel that rigged public bids to provide various high-technology medical supplies in the Brazilian pacemaker market.
PLMJ | Portugal | 19 Apr 2023
Portuguese health authorities extend validity period of prescriptions for medicines and complementary services
A new ministerial order establishes the legal framework for the prescription and dispensation of medicines and health products, and defines the obligations regarding information to be provided to health service users. Previously, the validity period of prescriptions for medicines was 30 days. This has now been extended to 12 months. This change was one of the measures proposed by the......
Lexology PRO | Asia-Pacific, China, European Union, etc. | 14 Apr 2023
Product regulation and liability: key updates and risks (April 2023)
China seeks to regulate generative AI products, the EC proposes a directive targeting greenwashing, and the US raises duty rates on Russian-imported aluminum products – plus other key updates.
