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

On June 23, 2022, Thailand’s Securities and Exchange Commission (SEC) opened a public hearing period on regulatory controls for initial coin offering (ICO) portals that serve as financial advisors to digital token issuers. The proposed measures aim to prevent conflicts of interest; allow ICO portals to outsource certain functions; and establish additional notification obligations for ICO portals. The public hearing is open for general comments until July 23, 2022, and the new legislation is expected to be issued soon after that. During the public hearing period, any interested parties can comment on the SEC’s proposed principles. The key proposed points are outlined below. Conflicts of Interest Similar to SEC-approved financial advisors for securities offerings, ICO portals must be clear of conflicts of interest when representing issuers in a coin offering. According to the draft regulation, the following conflicts of interest are prohibited: The ICO portal (and certain individuals as specified by the SEC) directly or indirectly holds a prohibited amount of shares in the issuer, its affiliates, or its subsidiaries. If the issuer is not a listed company, any shareholding or portion thereof is prohibited. If the issuer is a listed company on the Stock Exchange of Thailand (SET), the shares held by the ICO platform may not total more than five percent of the total voting rights. The issuer (and certain individuals as specified by the SEC) directly or indirectly holds shares in the ICO portal in any amount if the ICO portal is not a listed company, or totaling more than five percent of the voting rights if the ICO portal is listed on the SET. Any of the ICO portal’s directors or executives, or the head of the department responsible for screening the ICO project, is also a director in the issuer. The ICO portal has

Patent is an essential piece of the amended Law on Intellectual Property (“Amended IP Law”), which was passed by the National Assembly of Vietnam on June 16, 2022, and will take effect on January 1, 2023 (except for the regulation on protection of experimental data for agrochemical products, which will take delayed effect on January 14, 2024). Among the amended and supplemented contents of the Amended IP Law, there are notable patent-related amendments to Article 60 on assessing the novelty of inventions and Article 96 on grounds for invalidating patent protection titles. We discuss these changes below. Secret Prior Art Under Article 60.1 A significant amendment to Clause 1, Article 60 of the Amended IP Law on the novelty of inventions is to broaden the scope under which an invention can be considered to have lost its novelty. For the first time in Vietnam, “secret prior art” –a patent application with an earlier filing date or priority date but published on or after the filing date or priority date of an examined patent application – is introduced as a prior art document. In the diagram above, at the time of filing of the A2 application, secret prior art A1 has been filed but not yet published, making it inaccessible to the public. At this point, only the A1 applicant and the IP Office are aware of the A1 application. Under the current provisions of the 2005 IP Law, as amended in 2009 and 2019, the A1 patent application is not eligible to be a prior art document when assessing the novelty of A2. However, based on the “first-to-file principle” and the principle of priority, the IP Office has still had other approaches to bar the patentability of an A2 patent application if there is such an A1 application. By

On May 30, 2022, Thailand’s Securities and Exchange Commission (SEC) announced that it would start regulating ready-to-use utility tokens, a type of digital token that had previously been exempted from the SEC’s approval and regulatory control. A public forum was open for comments from various stakeholders until June 29, 2022, and the draft regulation is expected to be issued soon. So far, the SEC has only supervised the issuance of not-ready-to-use utility tokens—digital tokens with the underlying right to acquire specific goods or services, which cannot be utilized upon issuance but at a later date. Due to the growing digital asset industry and lack of regulatory control, ready-to-use utility tokens have become more popular and many are listed for trading in digital asset exchanges. The SEC claimed that it is now necessary to regulate ready-to-use utility tokens as some issuers appeared to be exploiting the regulatory loophole to manipulate the price and supply of these tokens in both the primary and secondary markets, while providing insufficient data disclosure to investors. The SEC’s proposed principles include the following key points: Pre-Approval Requirements The same pre-approval requirement applicable to not-ready-to-use utility tokens will apply to ready-to-use utility tokens which an issuer intends to list on a digital asset exchange. This means that the issuer must proceed with the standard formalities, i.e., obtaining prior approval from the SEC, filing a draft prospectus, and offering the approved tokens via a SEC-approved ICO portal operator only. The SEC offers a fast-track (15 days) approval for qualifying ready-to-use utility tokens, which are those with plain-vanilla characteristics; with an offering price corresponding to the value of the underlying goods/services; for which the supply of goods and services does not vary with the price of the tokens (i.e., fixed coins); and which are not intended to be