Is the Use of Ultrasound Diagnostic Devices by Korean Medicine Doctors Illegal?… Supreme Court Full Bench to Deliver Verdict Today

[Asia Economy Reporter Choi Seok-jin, Legal Affairs Specialist] On the 22nd, the Supreme Court's full bench will issue a ruling on whether an Oriental medicine doctor using an ultrasound diagnostic device on a patient violates the current Medical Service Act and is subject to punishment.

In a public opinion survey conducted by the Korean Oriental Medicine Association this year, 8 out of 10 citizens supported the use of modern diagnostic medical devices by Oriental medicine doctors, citing reasons such as reducing medical expenses. However, with the Korean Medical Association strongly opposing this, attention is focused on how the Supreme Court will make its final judgment.

The Supreme Court full bench (Presiding Justice Cheon Dae-yeop) will hold the sentencing hearing for the appeal of Oriental medicine doctor A, who was indicted for violating the Medical Service Act, starting at 2 p.m. on the same day.

A, who runs an Oriental medicine clinic in Gangnam-gu, Seoul, was prosecuted on charges of performing medical acts beyond the scope of his license by using an ultrasound diagnostic device (model LOGIQ P5) a total of 68 times while treating patient B from March 2010 to June 2012.

Patient B, who was treated by A, had been receiving treatment at Seoul National University Hospital under the diagnosis of endometrial hyperplasia. When the condition did not improve, B visited A's Oriental medicine clinic after seeing an advertisement for a specialized uterine and ovarian treatment hospital. It was investigated that A used an ultrasound diagnostic device to capture images of B's internal body parts and diagnosed the condition of the endometrium by observing the ultrasound images as a method of medical treatment.

The prosecution judged that A performed 'medical acts other than those licensed,' which are prohibited under the Medical Service Act, and indicted him for violating Article 27, Paragraph 1 of the Medical Service Act.

Article 27 (Prohibition of Unlicensed Medical Acts, etc.) Paragraph 1 of the Medical Service Act states, "No one who is not a medical professional may perform medical acts, and even medical professionals may not perform medical acts beyond those licensed."

If violated, according to Article 87-2 (Penalties) Paragraph 2, Item 2 of the same law, the offender shall be punished by "imprisonment for up to five years or a fine of up to 50 million won."

Previously, the first and second trials recognized A's guilt for violating the Medical Service Act and sentenced him to a fine of 800,000 won.

In the lower court trials, A's side argued that A's use of the ultrasound diagnostic device falls within the scope of medical acts licensed for Oriental medicine doctors.

A's lawyer cited the following grounds: ▲ The operating principle of the ultrasound diagnostic device is based on physical principles, not Western medical principles; ▲ The ultrasound diagnostic device itself is safe, as it is also used on fetuses and pregnant women; ▲ Oriental medicine doctors receive education on the use of ultrasound diagnostic devices through formal courses and use them only within the scope of Oriental medical practice; and ▲ The use of ultrasound diagnostic devices by Oriental medicine doctors is desirable from the perspective of protecting and promoting public health.

However, the court did not accept these claims.

The court first cited a previous Supreme Court precedent.

In 2014, the Supreme Court overturned and remanded a lower court ruling that acquitted Oriental medicine doctor C, who was prosecuted for violating the Medical Service Act for treating about 100 patients using an IPL (Intense Pulse Light) device for skin disease treatment such as blemish removal.

At that time, the Supreme Court stated, "The Medical Service Act does not define or provide criteria distinguishing the licensed medical acts of doctors and Oriental medicine doctors. Therefore, whether a specific medical act by a doctor or Oriental medicine doctor constitutes 'medical acts other than those licensed' must be reasonably judged based on social norms by comprehensively considering the legislative purpose of the dual medical system, the provisions and intent of laws related to the medical act, the academic principles underlying the medical act, the circumstances, purpose, and nature of the medical act, and whether the expertise of the medical act can be secured through medical or Oriental medical school curricula or national examinations."

It further stated, "Whether the use of newly developed or manufactured medical devices due to advances in medical engineering, other than traditional medical devices or techniques passed down in Oriental medicine, constitutes 'medical acts other than those licensed' by Oriental medicine doctors should also be judged based on these legal principles, comprehensively considering whether there are regulations prohibiting the use of such medical devices by Oriental medicine doctors, whether the development and manufacturing principles of the devices are based on the academic principles of Oriental medicine, whether the medical acts using such devices can be regarded as applications or implementations of Oriental medicine theories or principles, and whether the use of such devices requires specialized knowledge and skills in Western medicine that could cause health hazards if used by Oriental medicine doctors."

In the current case, the court noted that the ultrasound diagnostic device used by A corresponds to a relatively low-risk Class 2 device according to the classification criteria under the Medical Device Act Enforcement Rules at that time, and that the temperature increase effect during use is minimal, with no reports of serious side effects such as cell membrane or chromosome damage, so the risk from the use itself is not considered high.

The court also acknowledged that A took courses related to ultrasound diagnosis in Oriental medicine school and continuously received classes on the use of ultrasound diagnostic devices from the Korean Oriental Medicine Ultrasound Organ Morphology Society while working as an Oriental medicine doctor.

However, the court pointed out, "The examination and diagnostic acts using an ultrasound diagnostic device require the examiner to immediately decide and conduct additional tests if abnormal symptoms or suspected specific diseases are present, making accurate interpretation essential. If the patient's condition is not accurately diagnosed during the examination and diagnosis using the ultrasound diagnostic device, appropriate treatment methods cannot be selected, posing a risk to human life or physical safety."

It added, "Examination and diagnosis using ultrasound diagnostic devices are fundamentally specialized medical fields of radiology. Although the procedure of using the ultrasound diagnostic device may be relatively simple, evaluating the images requires extensive knowledge of the human body and imaging, as well as a thorough understanding of various phenomena, so it should be performed by radiologists or specialists in the relevant field with extensive ultrasound examination experience."

Even though the use of ultrasound diagnostic devices is not difficult and the risk is not high, the court judged that restricting Oriental medicine doctors' use is necessary because expertise is required to interpret the images and judge the examination results.

In fact, patient B, who received treatment from A in this case, was advised in early July 2012 after an ultrasound examination at an obstetrics and gynecology hospital that "a mass was seen, so you should receive treatment at a large hospital," and was diagnosed with stage 2 endometrial cancer after a biopsy at Boramae Hospital in Dongjak-gu, Seoul.

Previously, the Constitutional Court dismissed a constitutional complaint filed by doctors who used the ultrasound bone density measuring device 'Osteoimager plus' to perform growth plate examinations and prescribed constitutional improvement herbal medicine such as Galgeunhaegitang based on the results, requesting the cancellation of the prosecution's suspension of indictment. The court stated, "The acts of diagnosing patients' growth plate status, growth retardation, osteoporosis, etc., using the ultrasound device in this case or prescribing herbal medicine based on such diagnosis constitute 'medical acts' under the Medical Service Act."

At that time, the Constitutional Court stated, "Licensed medical acts for the complainants, who are Oriental medicine doctors, are considered Oriental medical acts. Our Medical Service Act and related medical laws distinguish between Western and Oriental medical fields, prohibiting and punishing medical acts beyond those licensed in each field. However, there are no specific provisions on whether certain medical acts are permitted or prohibited. Therefore, whether a specific act constitutes an Oriental medical act should be judged comprehensively considering the nature and purpose of the medical act, academic basis, level of education in specialized knowledge, and related regulations."

The Constitutional Court also ruled that expressions such as 'doctor,' 'scope of license,' and 'Oriental medical acts' under the Medical Service Act do not violate the principle of legality derived from the principle of clarity.

Meanwhile, in a public opinion survey conducted in May by the Korean Oriental Medicine Association through the polling agency Realmeter targeting 3,000 adult men and women nationwide, 84.8% of respondents answered that they 'support' the use of modern diagnostic medical devices by Oriental medicine doctors. Among them, 29.3% answered 'strongly support,' and 55.5% answered 'somewhat support.' Those who answered 'oppose' accounted for 13.6% (4% strongly oppose, 9.6% somewhat oppose). The remaining 1.6% answered 'don't know.'

This content was produced with the assistance of AI translation services.