European Union: Impact of the Artificial Intelligence Act (EU
in short EU Regulation 2024/1689 on Artificial Intelligence aims to introduce strict rules on the design, implementation and placing on the market of artificial intelligence systems. It applies to suppliers established within Europe and suppliers established outside the EU. The impact of the above regulations on so-called SAMD (i.e. software as medical devices) classified as "high risk" appears to be equally significant. In this regard, it is worth noting how such obligations will come into effect from 2 August 2027 for artificial intelligence systems classified as “high risk”, while from 2 August 2026 the Regulation will be universally applicable. Questions remain about how the regulation will be implemented. For Class I medical device software, designated agency intervention is obviously not required, and they would not fall within the concept of "high risk" AI SAMD, provided that such SAMDs are not classified as medical devices, or do not fall within the concept of "high risk" AI SAMD category. Medical devices higher…
EU: OECD Survey – Confidentiality Agreements and
in short A recently published OECD survey involving 43 member countries found that less than half require publication of list drug prices, while the remainder are hampered by legal and/or contractual restrictions that prevent the publication of drug price information. More specifically, the survey revealed the following results: (one) Nine of 43 countries reported the existence of domestic legal provisions that prohibit or otherwise severely limit the public disclosure of net drug price information; (two) Six of 43 countries reported transparency barriers due to legal restrictions that prevent medicine price sharing; (three) Thirty-two of 43 countries reported the existence of contractual clauses limiting the sharing of drug price information; (Four) All 43 countries surveyed expressed a strong interest in obtaining information on prices paid for medicines, both to guide price negotiations and to regulate external reference pricing and joint procurement initiatives; (five) Only 20 out of 43 countries have mandatory price disclosure. While the international community clearly has a strong…
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