September 15, 2021
Studies conducted in Thailand have revealed that Thai herbs, e.g., Andrographis Paniculata (Burm.f.) and fingerroot (Kaempfer or Boesenbergia rotunda) can treat COVID-19 symptoms, and there have been some indications that these herbs may be able to suppress SARS-CoV-2 and stop the virus from replicating. The COVID-19 pandemic in Thailand, along with results from research into Thai herbal remedies has led to the increase in the sale of Thai herbs. As such, many players in this area should be aware of the regulatory framework for the production and sale of such products in Thailand. Introduction In 2019 the Herbal Product Act B.E. 2562 (2019) (“HPA”) was issued to centralize the regulations governing herbal medicines, with the Food and Drugs Administration (“FDA”) being the competent authority under the HPA. Under the HPA, “Herbal Product” is defined as follows: Medicine from herbs, including Thai traditional medicine, medicine developed from herbs, traditional medicine for human usage under the medicine laws, or medicines that are derived from the knowledge of alternative medicine as prescribed and notified by the Minter of Public Health upon the recommendation of the Herbal Product Committee, for the treatment, cure and relief of human illnesses or the prevention of diseases Products from herbs, or products which contain active ingredients composed of or processed from herbs, which are ready for human use to improve health or bodily functions, reinforce bodily structure or functions of humans, or lessen the risk factors for illness Objects which are intended to be used as ingredients in the production of herbal products Other objects prescribed and notified by the Minister of Public Health upon the recommendation...
September 2, 2021
U.S. Regulatory Considerations Applicable to Digital Health Providers and Suppliers: Primary Regulatory Regimes Relevant to mHealth – Part IV: Other Potential Applicable Laws We conclude our series by examining other relevant laws digital health providers and suppliers should know. If you missed our earlier articles, you can read about HIPAA in Part I and II, and the FDCA and other privacy considerations in Part III. Federal Trade Commission Act (FTCA) When companies tell consumers they will safeguard their personal information, the Federal Trade Commission (FTC) can and does act to ensure companies live up to their promises. The FTC has brought legal actions against organizations that have violated consumers’ privacy rights, misled them by failing to maintain security of sensitive consumer information or caused substantial consumer injury. In many cases, the FTC has charged the defendants with violating laws related to unfair and deceptive trade practices. As a recent example, a developer of a popular women’s fertility-tracking app settled FTC allegations that it misled consumers about the disclosure of consumers’ health data. As part of the proposed settlement, the developer is prohibited from misrepresenting: 1) the purposes for which it or entities to whom it discloses data collect, maintain, use or disclose the data; 2) how much consumers can control these data uses; 3) its compliance with any privacy, security or compliance program; and 4) how it collects, maintains, uses, discloses, deletes or protects users’ personal information. Additionally, the developer must notify affected users about the disclosure of their personal information and instruct any third-party that received users’ health information to destroy that data. [1] In addition, FTC also...
September 2, 2021
US Regulatory Considerations Applicable to Digital Health Providers and Suppliers: Primary Regulatory Regimes Relevant to mHealth – Part III: FDCA This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act (FDCA), as well as regulatory issues unique to non-US companies. If you missed the first articles in our series, we examined HIPAA provisions in Part I and II. Federal Food, Drug and Cosmetic Act (FDCA) What is FDCA? FDCA regulates the safety and effectiveness of medical devices, including certain mobile medical apps. A “device” or medical device means “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is … intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease … or intended to affect the structure or function of the body of man or other animals….” [1] Software intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention or treatment of a disease or condition” is specifically excluded from the FDCA’s “device” definition. [2] The US Food & Drug Administration (FDA) enforces the FDCA. Application of FDCA to mHealth application developers Policy for Device Software Functions and Mobile Medical Applications Guidance (2019) explains FDA’s oversight of device software functions including mHealth apps as medical devices. [3] The guidance confirmed (i) the FDA considers mobile medical apps to be within its regulatory authority and (ii) the FDA’s intent to focus regulatory oversight on a subset of health apps...
September 2, 2021
US Regulatory Considerations Applicable to Digital Health Providers and Suppliers: Primary Regulatory Regimes Relevant to mHealth – Part II: HIPPA (Continued) & Additional Important Privacy Considerations. In Part I, we provided a high-level overview of Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its provisions. In Part II, we discuss how HIPAA is applied to mobile health (mHealth) application developers, as well as examine additional privacy issues and considerations that non-US companies should keep in mind. HIPAA Overview (Continued) Application of HIPAA to mHealth application developers General If a Covered Entity is the developer of a mobile application (“app”) and the app uses PHI, HIPAA will apply and will govern the creation, receipt, maintenance and transmission of PHI by the app (unless the PHI was acquired pursuant to a HIPAA-compliant patient authorization specifically releasing the data to the app developer). If the app developer is not a Covered Entity, a key consideration is if the developer is acting as a Business Associate of a Covered Entity or is a subcontractor of a Business Associate. In other words, does the app developer create, receive, maintain or transmit PHI on behalf of a Covered Entity or Business Associate? Key Questions: Does the mHealth app create, receive, maintain or transmit PHI? What types of entities or individuals are the ultimate users of the app? Who are the app developer’s clients? How is the app funded? Are the app developer’s clients Covered Entities, such as hospitals, physician practices, clinics, urgent care facilities, pharmacies, clinical or diagnostic laboratories or other health care providers? Are the app developer’s clients’ health plans, health insurance...
August 30, 2021
On July 30, 2021, the Central Administrative Court rendered its verdict against, among others, the Director of Wattana District, Bangkok Metropolis; the Governor of Bangkok Metropolis; and the Governor of the Mass Rapid Transit Authority of Thailand, revoking all governmental authorizations with respect to the construction of Ashton Asoke Condominium Project. Such verdict has had an immense impact on the developer of such condominium project, Ananda Development PCL (SET: ANAN), one of the most reputable Stock Exchange of Thailand-listed real estate developers, that has developed many well-established condominium brands, such as Ashton, Ideo, Ideo Mobi and Elio, and has also inevitably raised several questions for Ananda’s customers who have purchased condominium units in Ashton Asoke Condominium Project. Therefore, we would like to take this opportunity to analyze such verdict and flag certain key takeaways and debatable issues, while we await the final result of one of the landmark real estate-related lawsuits in Thailand. Issue Does Ashton Asoke Condominium Project (the “Project”) comply with Section 2, paragraph 2 of the Ministerial Regulation No. 33 (B.E. 2535 (1992)) Issued by Virtue of the Building Control Act B.E. 2522 (1979) (the “Ministerial Regulation No. 33”), as interpreted by the Central Administrative Court (the “Court”)? Underlying Rule Section 2. paragraph 2 of the Ministerial Regulation No. 33 (the “Underlying Rule”) requires that at least a single side (with at least 12 meters in length) of the “site area” on which a high-rise building or an extra-large building (in each case, with gross floor area of greater than 30,000 square meters) is situated be adjacent to a “public road” with the boundary width of...
August 16, 2021
Following the various types of lockdown measures introduced to limit the spread of Covid-19, many corporations had to pause their work or continue only with limited capacity. Small companies especially took significant losses and many were forced to shut to staunch the financial bleeding. However, it is worth noting that the law has options to help save a distressed company. Republic Act No. 10142 (the Financial Rehabilitation and Insolvency Act of 2010, or FRIA) encourages struggling businesses – including sole proprietorships, partnerships, corporations and individual debtors – to undergo rehabilitation. The FRIA does not apply to banks, quasi-banks, insurance companies or pre-need companies, all of which are governed by different laws and regulations. Rehabilitation allows for the continuation of corporate activities as a business is restored to solvency (Wonder Book Corporation v. Philippine Bank of Communication, G.R. No. 187316, 2012). The process may be court-supervised (which may either be voluntary or involuntary, depending on the initiator), follow a pre-negotiated plan or use out-of-court or informal proceedings. Court-Supervised Rehabilitation If a business is unable to pay its obligations, an insolvent debtor may voluntarily begin a rehabilitation proceeding by filing a petition with the court. The party who can initiate the petition depends on the type of business. For instance, if the company is a sole proprietorship the party will be the owner. If it is a partnership, initiation will require agreement of the majority of the partners. And in stock corporations, the party will be a majority vote of the Board or trustees, authorized by at least a two-thirds vote of the outstanding capital stock (or of the members, in...