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Healthcare & Life Sciences Hub Insight Baker McKenzie

WEBLife sciences companies continue to face a myriad of requirements to ensure compliance with a highly regulated industry environment. As businesses innovate in a digital and …

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URL: https://www.bakermckenzie.com/en/insight/topics/healthcare-life-sciences

AI for Health: Regulatory Considerations Published by the WHO

WEBIntroduction. Following our post here on the EMA’s consultation on the use of Artificial Intelligence (AI) in the medicinal product lifecycle, which is open for public …

Category: Health Go Health

The Health Pod Insight Baker McKenzie

WEBResolving the health crisis demands an immediate response from regulatory agencies. In this episode of The Health Pod, Kamleh Nicola and Veleka Peeples-Dyer join David Wardell in discussing some of the most …

Category: Health Go Health

Singapore: Updates to the HSA's Health Supplements …

WEBThe health supplement market in Singapore is projected to grow into a SGD 740 million industry by 2024. For many years, health supplements regulation in Singapore had …

Category: Supplements Go Health

Indonesia: New medical records regulation — what's new

WEBThe promulgation of MOH Regulation 24 underlines the digital transformation in Indonesia's healthcare sector, as the regulation sets out detailed provisions on implementing the new electronic medical records …

Category: Medical Go Health

Singapore: Updates to the HSA's Software as a Medical …

WEBIn brief. In April 2022, the Health Sciences Authority (HSA) published its revised Regulatory Guidelines for Software Medical Devices ("SaMD Guidelines").It has also finalised its new Guidelines on Risk …

Category: Medical Go Health

UAE: Health Data Law – Permitted Transfers of Health Data

WEBThe UAE’s Ministry of Health and Prevention ( MoHAP) has issued a long awaited resolution setting out exceptions to Article 13 of Federal Law No. 2 of 2019 (“ Health Data Law “), which by default …

Category: Health Go Health

CLINICAL TRIALS HANDBOOK

WEBIntroduction. In Canada, a clinical trial for a drug product (CT) comprises an investigation for use in humans that is intended to discover or verify the clinical, pharmacological or …

Category: Health Go Health

UAE: Update on Health Regulations

WEBThe long awaited Implementing Regulations under Federal Law No. 2 of 2019 concerning the Use of the Information and Communication Technology in the Areas of Health (the “Health Data …

Category: Health Go Health

UAE: Health Data Law Baker McKenzie Resource Hub

WEBThe UAE's Ministry of Health and Prevention (MoHAP) has issued a long awaited resolution setting out exceptions to Article 13 of Federal Law No. 2 of 2019 (" Health Data Law "), …

Category: Health Go Health

Thailand: Progressing towards an integrated digital health ecosystem

WEBRelevant stakeholders in the digital healthcare ecosystem have been progressing their digital transformation plans which ultimately, if they are able to collaborate effectively, …

Category: Health Go Health

Asia Pacific Food Law Guide

WEBThe Director of the Food and Environmental Hygiene Department ("FEHD") has the power to examine/seize any food which it considers unfit for human consumption (Section 59 of …

Category: Food Go Health

Singapore: Ministry of Health to table Health Information Bill to

WEBIn brief. The Ministry of Health (MOH) has confirmed its intention to table the Health Information Bill (Bill) in the second half of 2023.Through the Bill, the MOH seeks to …

Category: Health Go Health

Asia Pacific Food Law Guide

WEBThey are assigned by the Ministry of Health to perform this specific function (e.g., the Institute of Hygiene and Public Health of certain cities and provinces). In order to avoid …

Category: Health Go Health

Cosmetic Product Regulations

WEBThe Health Sciences Authority has implemented the ASEAN Cosmetic Directive under the Health Products Act for the regulatory control of cosmetic products, with effect from 1 …

Category: Health Go Health

Singapore: Health Sciences Authority proposes regulation for …

WEBOn 17 July 2023, the Health Sciences Authority (HSA) proposed the new regulation for active ingredients under the Health Products Act. Against the increasing complexity in …

Category: Health Go Health

UAE: Health Data Law Permitted Transfers of Health Data

WEBThe UAE's Ministry of Health and Prevention (MoHAP) has issued a long awaited resolution setting out exceptions to Article 13 of Federal Law No. 2 of 2019 ("Health Data Law"), …

Category: Health Go Health

Asia Pacific Food Law Guide

WEBThe Vietnamese National Assembly adopted Law No. 55/2010/QH12 on Food Safety on 17 June 2010 (Food Safety Law).The Food Safety Law stipulates the rights …

Category: Food Go Health

New Jersey Health Care Directive and Appointment of Health …

WEBinformation governed by the Health Insurance Portability and Accountability Act of 1996 (aka “HIPAA”), 42 USC 1320d and 45 CFR 160-164 and by providing this release, my …

Category: Health Go Health

France: Publication of the ordinance adapting French law to the EU

WEBIn brief. On 20 April 2022, the French government adopted an ordinance (Ordinance) adapting French law to EU Regulation 2017/745 on medical devices (MDR). Although …

Category: Medical Go Health

Indonesia: Health Omnibus Law series – Key updates on …

WEBFor context, under the Health Omnibus Law, 'pharmaceutical preparations' is defined as drugs, drug materials and natural drugs, including natural drug materials, cosmetics, …

Category: Health Go Health