Newsletter
Summary of Draft Amendment to Rules of Medical Diagnosis and Treatment by Telecommunications announced by Ministry of Health and Welfare
Article 11 of the Physician's Act stipulates that physicians should, as a general rule, provide healthcare in person, except in mountains, on outlying islands, in remote areas, or under special or urgent circumstances, where a physician may provide healthcare by means of telecommunications technology (i.e., telemedicine). Based on the foregoing, the Rules of Medical Diagnosis and Treatment by Telecommunications (the "Rules") were promulgated by the Ministry of Health and Welfare (the "MOHW") on May 11, 2008. However, the applicable circumstances and scope of telemedicine permitted under the Rules remains rather limited.
In response to the outbreak of Covid-19 in 2020, Taiwan's Central Epidemic Command Center (CECC) announced the policy to "make extensive use of telemedicine for outpatient care to preserve inpatient capacity of hospitals during the pandemic". In this connection, the MOHW relaxed the restrictions on and expanded the scope of telemedicine to, inter alia, allow more healthcare organizations (HCOs) and patients to offer and receive telemedicine. As a result, telemedicine flourished during the pandemic. Drawing from the knowledge and experiences amassed in this field during the height of the pandemic, the MOHW proposed certain amendments to the Rules (the "Draft Amendment") on November 24, 2022. The key points of the Draft Amendment are as follows.
I. Expanding the scope of the special circumstances/patients eligible to receive telemedicine (Amended Articles 3 to 12)
(I) Currently, the "special circumstances" where telemedicine can be offered under the Rules only include the following five categories of circumstances/patients:
1. discharged patients who were hospitalized for acute illnesses receiving follow-up treatment within 3 months of their discharge;
2. chronic patients in long-term residential care institutions;
3. patients designated under the laws and regulations relating to the family physician integrated care system;
4. patients approved for home care by the government; and
5. overseas patients receiving cross-border healthcare.
(II) In addition to the above five categories, the Draft Amendment includes further categories of circumstances/patients eligible to receive telemedicine, which together are as follows:
1. patients receiving follow-up care for acute illnesses;
2. patients receiving long-term pharmaceutical care for chronic diseases;
3. patients receiving long-term care services (expanded to cover welfare institutions for the elderly, welfare institutions for the physically and mentally challenged, and nursing care institutions, etc.);
4. patients covered by the family physician integrated care system;
5. patients receiving home care;
6. patients receiving end-of-term care;
7. patients receiving reduced-mobility care;
8. patients receiving care for disasters, communicable diseases or other types of major accidents;
9. patients receiving cross-border care; and
10. other circumstances designated by the competent authority.
II. Expanding the items of permitted telemedicine practice and authorizing the MOHW to establish the format of electronic prescription (Amended Article 14)
Under the prevailing Rules, a physician may inquire patient history, conduct medical examination, write prescription, give treatment instruction, adjust prescriptions or provide guidance thereon, or provide health education via telemedicine. The Draft Amendment now expands the scope to include making diagnoses, issue medical orders, ordering tests or examinations, offer consultations and providing preventive healthcare. In addition, the Draft Amendment authorizes the MOHW to establish the format of electronic prescriptions for those issued via telemedicine.
III. Conditionally allowing physicians to write prescriptions via telemedicine under special circumstances (Amended Article 15)
Under the current Rules, when offering telemedicine under the "special circumstances" specified therein, physicians are not allowed to issue prescriptions. Considering the need for physicians to write prescriptions when offering telemedicine under the "special circumstances", the Draft Amendment now allows physicians to write prescriptions for the following types of patients:
(I) the following types of patients who are under stable condition and are on a follow-up visit:
1. patients receiving follow-up care for acute illnesses;
2. patients receiving long-term pharmaceutical care for chronic diseases;
3. patients receiving long-term care services
4. patients covered by the family physician integrated care system;
5. patients receiving home care; and
6. patients receiving end-of-term care;
(II) the following types of patients who are on a first visit or follow-up visit:
1. patients living in mountains, outlying islands and remote areas;
2. patients receiving reduced-mobility care;
3. patients receiving care for disasters, communicable diseases or other types of major accidents;
4. patients receiving cross-border care; and
5. patients under urgent circumstances.
IV. Simplifying the administrative procedures for HCO applications to perform telemedicine under special circumstances (Amended Article 17)
Under the prevailing Rules, to perform telemedicine under special circumstances, an HCO should submit a telemedicine implementation plan to the local competent authority at the city/county level for approval. Now, the Draft Amendment simplifies the application process by allowing HCOs that have already been approved to perform telemedicine by the central competent authority (or any agency thereunder pursuant to relevant regulations) to submit the approval document in lieu of the telemedicine implementation plan to the local competent authority for recordation.
V. Adding cyber security requirements on the IT infrastructure used for telemedicine (Amended Article 18)
Since the IT infrastructure used for telemedicine involves the transmission, exchange, storage and issuance of prescriptions, examinations and tests, the Draft Amendment requires that such IT infrastructure should be equipped with identity authentication mechanism and adopt encryption technology for data transmission that meets the requirements of international standards organizations, and should also comply with the relevant provisions under the Regulations Governing the Production and Management of Electronic Medical Record by Healthcare Organizations. Also, HCOs may delegate the establishment and management of the aforementioned IT infrastructure to universities, institutions, corporations or organizations, provided that they pass the cyber security standard certification recognized by the central competent authority.
VI. Relaxing the restrictions on the location where physicians are allowed to perform telemedicine and allowing physicians to exercise its professional judgment to assess the suitability of telemedicine for patients (Amended Article 19)
Under the prevailing Rules, physicians can only perform telemedicine on the HCO's premises. Now, considering the need to perform telemedicine outside an HCO in emergency or special circumstances, the Draft Amendment states that telemedicine should be performed on the HCO's premises as a general rule while in exceptional circumstances, it could be performed outside the HCO's premises. In addition, as not all patients are suitable for telemedicine, the Draft Amendment also specifies that physicians should recommend alternative means of care for patients who are not suitable for telemedicine.
Due to the pandemic, the healthcare community and the general public have become increasingly familiar with telemedicine. Despite the subsiding pandemic, telemedicine has become the new normal for the future of medicine. Following the enactment of the Draft Amendment, which will expand the scope of telemedicine, it is necessary for HCOs, primary care clinics, IT suppliers and health insurance providers to work together to offer more appropriate and well-rounded care for patients. Stakeholders can submit their comments or suggestions to the Draft Amendment within 60 days (i.e., by January 23, 2023) so that the MOHW can evaluate the comments and suggestions and adjust the content of the Draft Amendment accordingly before its enactment.
If you have any questions, please contact our Life Sciences practice group.