What does “digital health” include within each jurisdiction? Thailand: For the most part, the idea of “digital health” or “telemedicine” has generally fallen within the area of medical device regulation in Thailand. The normal sort of digital health components you would think of—like software and device accessories for diagnosis, monitoring, prevention, or treatment of illnesses—would fall into medical device classification, so long as they do not achieve their intended function by immunological, metabolic, or pharmacological means. The “digital health” devices you commonly think of, like mobile medical apps, wearable technologies and software, fall mainly within this definition. After the last update to the Medical Device Act in 2008, Thailand next looked at digital health in 2019, with the Personal Data Protection Act (PDPA)—which is largely aligned with GDPR principles—and the Cybersecurity Act. These deal with important issues arising from “digital health” and “telemedicine” like personal data protection, consent to use and consent to transfer data, and privacy. Vietnam: Similarly, in Vietnam, while there’s not a clear definition of “digital health” in the law, it is understood to include various types of medical devices, software, and online services used for healthcare purposes—including diagnosis and treatment as well as medical records and telemedicine. There’s no law on digital health, per se, but many of these areas are covered by separate circulars issued by the Ministry of Health. There’s a circular (referred to as “Circular 49”) from late 2017 on telemedicine, for example, that actually uses the term “telemedicine” to identify the industry and sets out licensing and technical requirements. Indicators such as this show that Vietnam is definitely embracing the concept. Indonesia: In Indonesia, there is also no precise definition of “digital health.” Digital health is regulated under several laws and regulations, such as provisions concerning medical devices under the health

Cambodia’s new food safety law addresses technical regulations and minimum requirements; import controls; labeling; and inspection, competent authorities, and penalties.

Thailand’s cannabis cultivation licensing scheme for the country’s transition toward legalization of the plant has now come to an end. The Ministry of Public Health (MOPH) announced in the Government Gazette that from June 9, 2022, “only cannabis extract with tetrahydrocannabinol (THC) of more than 0.2% by weight will be considered a narcotic.” This means that now anyone can grow, sell, or purchase cannabis seeds, plants, and inflorescence freely in Thailand, and licenses for the cultivation, possession, and distribution of cannabis are no longer required. Neither the number of cannabis plants nor the place of cultivation is restricted. It is thus the beginning of a new chapter for cannabis cultivation in Thailand, with many opining that now is a good time to enter this exciting and growing industry. The journey to this point began in 2019, when Thailand amended its laws on cannabis to allow for treatment for medical purposes, with one of the prerequisite conditions being that the cannabis must be grown in Thailand. The law was further amended to promote commercialization of the cannabis industry, allowing for cannabis to be added to food and beverages, cosmetics, and herbal products. In addition, three traditional cannabis-based formulas were listed in the universal healthcare coverage scheme, which means that almost all Thais have access to traditional cannabis recipes without cost. The successful launch of medical cannabis and its applications, and its viability as an economic industry, have become a national agenda and priority policy of the MOPH. In order to achieve the above outcomes, several legal frameworks and guidelines throughout the product’s lifecycle have been developed. For example, the Thai Food and Drug Administration (FDA) has so far granted licenses to cultivate cannabis (also known as a license to manufacture a narcotic) on more than 1,977 acres (around 800 hectares).

New technologies and production processes in the food industry have led to novel foods becoming increasingly important to both food manufacturers and the consuming public worldwide. This is very much the case across a number of jurisdictions in Southeast Asia. “Novel foods” refer to new food production processes, foods, and ingredients that have not yet been commonly used for human consumption, so these innovative foods require safety assessments before companies can produce and market them. While rules for these safety assessments are already part of novel food regulations in several other jurisdictions—such as the novel food regulations in the United Kingdom and European Union adopted in 2003, and the major reform of food safety laws in the United States passed in 2011 under the Food Modernization Act—similar rules governing the assessment of novel foods are relatively new or yet to be introduced in many parts of Asia. Nevertheless, it is important to understand the laws and practices that apply to safety assessments and the process of bringing novel foods to market in jurisdictions in the region. This article provides some clarity in this regard by summarizing important practical information on novel foods and the relevant required safety assessments in Indonesia, Thailand, and Vietnam.   Indonesia Regulator National Agency for Drug and Food Control (NADFC); frequently referred to as BPOM (Badan Pengawas Obat dan Makanan). Relevant Measures BPOM Regulation No. 27 Year 2018 concerning Public Service Standards in BPOM; Decision of the Director of Processed Food Standardization No. HK.02.02.51.511.06.21.21 Year 2021 concerning Public Service Standard Directorate Processed Food Standardization Definitions General “food ingredients” are basic fresh or processed ingredients that can be used to produce food; novel food is any food ingredient not listed in BPOM’s positive list of ingredients. Official Fees None   Process and Timeline Before submitting an