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United States: In the Emerging Patchwork of US State Consumer …

WebUnder CMIA, companies are prohibited from disclosing or using California residents' medical information for purposes not essential to the individual's health care services, unless an …

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Category: Health Go Health

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

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 …

Category: Medical Go Health

France: Recent updates on biosimilar drugs

WebIn brief. On 11 May 2022, the French National Agency for the Safety of Medicines and Health Products (ANSM) published a report on biosimilar drugs. This follows the entry …

Category: Medicine 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

Singapore: New Cybersecurity Labelling Scheme for Medical …

WebIn brief. To enable consumers and healthcare providers to make informed decisions when using and purchasing medical devices, the Cyber Security Agency of Singapore ("CSA"), …

Category: Medical Go Health

Singapore: Updates to the HSA's health supplements regulatory …

WebRevised HS Guidelines. The HS Guidelines provide a high-level regulatory overview of key requirements governing the import, manufacture and sale of health supplements in …

Category: Supplements 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 …

Category: Health Go Health

Spain: New Royal Decree on medical devices

WebIn more detail. The new Royal Decree 192/2023, of 21 March 2023, which regulates medical devices (RDPS) complements the application of the provisions of Regulation (EU) …

Category: Medical Go Health

Vietnam: New Decree on management of medical devices

WebDecree 98 sets out new regulations on price management measures for medical devices in order to address shortcomings and inadequacies in the previous price management …

Category: Medical 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 …

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

Singapore: HSA revises Guidance on Therapeutic Product …

WebThe Therapeutic Products Branch and the Health Products Regulation Group of the Health Sciences Authority (HSA) recently revised its Guidance on Therapeutic Product …

Category: Health Go Health

Vietnam: New law on medical examination and treatment

WebIn brief. On 9 January 2023, the National Assembly of Vietnam issued Law No. 15/2023/QH15 on Medical Examination and Treatment ("New Law"), which sets out …

Category: Medical Go Health

Philippines: DOH issues guidelines on disclosure of financial

WebThe Disclosure Guidelines require covered drug and medical device companies to submit Disclosure Reports on their financial relationships with healthcare providers and …

Category: Medical Go Health

Italy: Decree of the Ministry of Health on the pharmaceutical

WebIn brief. On 8 August 2023, the Ministry of Health issued a decree establishing a Task Force on the matter of systematic review of the pharmaceutical governance, to ensure greater …

Category: Health Go Health

UAE: Health Data Law Permitted Transfers of Health Data

Category: Health Go Health

Indonesia: Health Omnibus Law series – Key updates on …

WebOn 11 July 2023, Indonesia's house of representative (known as Dewan Perwakilan Rakyat Indonesia/DPR RI) approved the 2023 draft health law. A month later, the …

Category: Health Go Health

Indonesia: New Indonesian Medical Council Regulation on …

WebIn brief. On 29 April this year, the Indonesian Medical Council (Konsil Kedokteran Indonesia) ("KKI") issued KKI Regulation No. 74 of 2020 on Clinical Authorities and Medical …

Category: Medical Go Health