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The Rules of Medical Diagnosis and Treatment by Telecommunications (hereinafter, the “Rules”) were enacted and implemented on May 11, 2018 as a sub-law authorized under the proviso of the Physicians Act on the “principle of in-person diagnosis,” which, for the first time, breaks the restrictions on the conditions of diagnosis and treatment by telecommunications in “mountainous areas, outlying islands, and remote areas” and in “emergencies” and stipulates that diagnosis and treatment by telecommunications can apply to patients who have special care needs under “special circumstances” (see below).
Since the outbreak of COVID-19 in Taiwan, the National Health Insurance Administration of Ministry of Health and Welfare (hereinafter, the “MOHW”) further expanded the subjects of medical diagnosis and treatment by telecommunications to confirmed cases and general outpatients and relaxed the medical treatment items that may be administered by physicians during the diagnosis and treatment by telecommunications by promulgating the Amendments to the Guidelines for the Operation of Virtual Diagnosis and Treatment to the Insured by Contracted Medical Service Institutions under the National Health Insurance to Accommodate the COVID-19 Epidemic (hereinafter, the “Guidelines”) in May 2022. On November 24, 2022, the MOHW pre-announced the draft Amendments to the Rules, planning to normalize the regulation under the Guidelines.
These draft Amendments are highlighted below:
1. The scope of special circumstances specified in the proviso of Article 11, Paragraph 1 of the Physicians Act is expanded.
The “special circumstances” under which the current Rules may apply to medical diagnosis and treatment by telecommunications are limited to (1) post-discharge follow-up treatment for acute inpatients; (2) long-term care services; (3) family physician diagnosis and treatment; (4) follow-up treatment for remote care or home care; and (5) foreign patients who are not citizens of Taiwan and are not covered by the National Health Insurance.
The draft Amendments add the following four “special circumstances” to meet practical needs and maintain flexibility: (1) long-term medication and care for chronic diseases; (2) care for terminal illness; (3) care for mobility impairment; and (4) care for disasters, infectious diseases, or other major changes.
2. The treatment items of diagnosis and treatment by telecommunications are added, and the central competent authority is authorized to announce the format of electronic prescriptions.
The following table compares the amendments concerning items of medical diagnosis and treatment by telecommunications:
In addition, to standardize the format of electronic prescriptions, the draft Amendments authorize the central competent authority to separately announce the format of electronic prescriptions.
3. Physicians that administer medical diagnosis and treatment by telecommunications are conditionally allowed to issue prescriptions under special circumstances.
The current Rules still do not allow doctors to issue prescriptions for patients through diagnosis and treatment by telecommunications under “special circumstances.” However, the draft Amendments take into account the need for physicians to write prescriptions for patients under special circumstances when diagnosis and treatment by telecommunications is administered by allowing physicians to write prescriptions to the following patients.
4. The administrative procedure for a medical institution’s application to administer diagnosis and treatment by telecommunications under special circumstances is simplified.
Medical institutions that administer diagnosis and treatment by telecommunications under special circumstances as stipulated in the current Rules are required to prepare a plan for the implementation of diagnosis and treatment by telecommunications, and the plan shall be approved by the competent authorities in municipalities or counties (cities) before implementation.
To simplify the application process for medical institutions, the draft Amendments add the exception that if a medical institution has been approved by the central competent authority or its affiliated agency to perform diagnosis and treatment by telecommunications in accordance with other laws and regulations, the approval document can replace the procedure of submitting and approving the implementation plan and can be directly submitted to the competent authority in the municipality or county (city) for recordation.
5. The information and communications security requirements for the information system of the diagnosis and treatment by telecommunications are added.
In view of the fact that medical records, various examination and test reports, and other records produced by various medical personnel in the performance of their duties are all important documents of medical institutions and are also special personal data under the Personal Data Protection Act, the draft Amendments additionally stipulate, based on information and communications security, that information systems used for diagnosis and treatment by telecommunications involving the transmission, exchange, storage of medical records, or issuance of prescriptions, examinations, and tests should be equipped with personal identity verification and data transmission encryption mechanisms in line with those commonly used by international standards organizations, and should comply with the relevant provisions of the Regulations Governing the Preparation and Administration of Electronic Medical Records by Medical Institutions.
6. The restrictions on the locations from which a physician may administer diagnosis and treatment by telecommunications are eased; and physicians are granted the right to assess the appropriateness of administering diagnosis and treatment by telecommunications to patients based on their expertise.
The current Rules stipulate that diagnosis and treatment by telecommunications shall be administered within medical institutions. The draft Amendments consider the need of physicians to administer diagnosis and treatment by telecommunications outside medical institutions under emergency or special circumstances, and therefore change the provision that ” diagnosis and treatment by telecommunications shall be administered in medical institutions” to a principle-based regulation.
In addition, considering that not all patients are suitable for diagnosis and treatment by telecommunications, the draft Amendments grant physicians the right to weigh if a patient’s condition is suitable for diagnosis and treatment by telecommunications, and if the physician assesses that it is not suitable, the physician should recommend the patient to seek medical attention on his/her own or administer the diagnosis by other means.
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