Supreme Court: "Use of Ultrasound Diagnostic Devices by Korean Medicine Doctors Is Not a Violation of Medical Law"… First Ruling

Supreme Court Grand Bench.
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[Asia Economy Reporter Choi Seok-jin, Legal Affairs Specialist] The Supreme Court has ruled that a Korean medicine doctor using an ultrasound diagnostic device on patients does not violate the Medical Service Act.

Although there have been several lower court cases where the use of ultrasound diagnostic devices by Korean medicine doctors was confirmed as a violation of the Medical Service Act, the Supreme Court had never explicitly ruled on this issue, and the Constitutional Court had previously judged it as unlicensed medical practice.

This time, the Supreme Court clearly stated that the use of ultrasound diagnostic devices by Korean medicine doctors does not violate the Medical Service Act by presenting clear standards regarding the use of diagnostic medical devices.

The Supreme Court's full bench (Presiding Justice Cheon Dae-yeop) overturned the lower court's ruling that sentenced Korean medicine doctor A to a fine of 800,000 KRW and remanded the case to the Seoul Central District Court during the appeal hearing held on the afternoon of the 22nd.

A, who runs a Korean medicine clinic in Gangnam-gu, Seoul, was prosecuted on charges of performing medical acts beyond the licensed scope by using an ultrasound diagnostic device (model LOGIQ P5) 68 times while treating patient B from March 2010 to June 2012, violating Article 27(1) of the Medical Service Act.

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 Korean medicine clinic after seeing an advertisement for a specialized uterine and ovarian treatment hospital. A used the ultrasound diagnostic device to image B's internal body and diagnosed the condition of the endometrium by observing the ultrasound screen.

After receiving treatment from A, B underwent an ultrasound examination at an obstetrics and gynecology hospital in early July 2012 and was advised to seek treatment at a larger hospital due to a detected mass. A biopsy conducted at Boramae Hospital in Dongjak-gu, Seoul, diagnosed stage 2 endometrial cancer.

The prosecution judged that A performed medical acts beyond the licensed scope prohibited under the Medical Service Act and indicted A for violating Article 27(1) of the Medical Service Act.

Article 27(1) of the Medical Service Act (Prohibition of Unlicensed Medical Practice, etc.) states that "No one other than a medical professional may perform medical acts, and even medical professionals may not perform medical acts beyond their licensed scope." Violations are punishable by imprisonment of up to five years or a fine of up to 50 million KRW under Article 87-2(2)(2) of the same Act.

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

Supreme Court Presents New Standards, Changes Previous Precedents

The court stated, "The lower court maintained the first trial's ruling that found guilt based on previous Supreme Court precedents regarding whether the use of modern medical devices by Korean medicine doctors constitutes medical acts beyond the licensed scope. However, considering the provisions and purposes of laws related to medical acts, the variability of medical acts, the academic principles and scientific and technological advancements underlying them, the expansion of application areas, changes in education curricula, national examinations, and other public and social systems, as well as the reasonable choice possibility of medical consumers assuming no health and hygiene risks beyond the usual level accompanying medical acts, the previous standards for the use of diagnostic medical devices by Korean medicine doctors need to be newly reconstructed," the court pointed out.

On this day, the court presented new standards for the use of diagnostic medical devices by Korean medicine doctors, including ▲whether relevant laws prohibit Korean medicine doctors from using the specific medical device, ▲whether the characteristics of the diagnostic medical device and the basic and professional knowledge and skill levels required for its use suggest that its use as an auxiliary diagnostic tool by Korean medicine doctors could cause health and hygiene risks beyond the usual level accompanying medical acts, and ▲whether, considering the overall circumstances, purpose, and nature of the medical act, it is clear that the use of the diagnostic medical device by Korean medicine doctors is unrelated to applying or adapting the principles of Korean medicine medical acts, recommending a comprehensive and reasonable judgment based on social norms.

The court cited specific reasons why the use of ultrasound diagnostic devices by Korean medicine doctors does not constitute medical acts beyond the licensed scope: ▲there are no regulations prohibiting Korean medicine doctors from using ultrasound diagnostic devices, ▲it cannot be concluded that using ultrasound diagnostic devices as auxiliary diagnostic tools by Korean medicine doctors causes health and hygiene risks beyond the usual level accompanying medical acts, and ▲it is not clearly proven that the use of ultrasound diagnostic devices by Korean medicine doctors is unrelated to applying or adapting the principles of Korean medicine medical acts.

Finally, the court stated, "Considering the above circumstances in light of the legal principles, the defendant, a Korean medicine doctor, using the ultrasound diagnostic device as an auxiliary means for Korean medical diagnosis does not constitute 'medical acts beyond the licensed scope' under Article 27(1) of the former Medical Service Act." It added, "Nevertheless, the lower court maintained the first trial's ruling that found guilt, which is a misinterpretation of the scope of 'medical acts beyond the licensed scope' under Article 27(1) of the former Medical Service Act," explaining the reason for overturning and remanding the case.

It further stated, "Contrary to this, the Supreme Court rulings, including 2010Do10352, which applied the 'previous standards' without considering whether the use of diagnostic medical devices applies, and other rulings with the same intent, will be changed to the extent that they conflict with this ruling," it declared.

Lower Courts Convicted Based on Previous Supreme Court Standards... Constitutional Court Also Judged Medical Service Act Violation

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

A's lawyer cited as grounds ▲the operating principle of the ultrasound diagnostic device is based on physics, not Western medical principles, ▲the ultrasound diagnostic device is safe as it is used on fetuses and pregnant women, ▲Korean medicine doctors receive education on using ultrasound diagnostic devices through formal courses and use them only within the scope of Korean medical practice, and ▲the use of ultrasound diagnostic devices by Korean medicine doctors is desirable for protecting and promoting public health.

However, the court did not accept these claims.

The court first cited previous Supreme Court precedents.

In 2014, the Supreme Court overturned and remanded a lower court ruling that acquitted Korean medicine doctor C, who was prosecuted for using an IPL (Intense Pulse Light) device to treat over 100 patients for skin conditions such as blemish removal, on the grounds of violating the Medical Service Act.

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 Korean medicine doctors. Therefore, whether a specific medical act by a doctor or Korean medicine doctor constitutes 'medical acts beyond the licensed scope' should be reasonably judged based on social norms by comprehensively considering the legislative purpose of the dual medical system, the provisions and purposes 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 and Korean medicine university curricula and national examinations."

It also stated, "Whether the use of newly developed or manufactured medical devices due to advances in medical engineering by Korean medicine doctors beyond traditional medical devices or techniques constitutes 'medical acts beyond the licensed scope' should be judged based on whether relevant laws prohibit Korean medicine doctors from using such devices, whether the development and manufacturing principles of the devices are based on the academic principles of Korean medicine, whether the medical acts using such devices can be seen as applying or adapting Korean medicine theories or principles, and whether the use of such devices requires Western medical professional knowledge and skills, potentially causing health and hygiene risks if used by Korean medicine doctors," thus presenting standards for judging violations of the Medical Service Act regarding the use of modern diagnostic medical devices by Korean medicine doctors.

The lower court acknowledged that the ultrasound diagnostic device used by A was classified as a relatively low-risk Class 2 device under the Medical Device Act enforcement regulations at the time, and that its use caused minimal temperature rise effects with no reports of serious side effects such as cell membrane or chromosome damage, thus the risk from its use was not significant.

It also recognized that A had taken courses related to ultrasound diagnosis in Korean medicine school and had continuously received training on the use of ultrasound diagnostic devices through the Korean Medicine Ultrasound Meridian Morphology Society while practicing as a Korean medicine doctor.

However, the court pointed out, "Ultrasound diagnostic testing and diagnosis require the examiner to immediately decide and conduct additional tests if abnormal symptoms or suspected specific diseases are present, making accurate interpretation essential. Failure to accurately diagnose the patient's condition during the ultrasound examination and diagnosis process may lead to inappropriate treatment choices, posing risks to life or physical safety."

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

Even though using the ultrasound diagnostic device is not difficult and not highly risky, the court judged that the expertise required to interpret the images and assess the test results necessitates restricting Korean medicine doctors' use.

Previously, the Constitutional Court dismissed a constitutional complaint filed by doctors who used the ultrasound bone density measuring device 'Osteoimager plus' for growth plate examinations and prescribed herbal medicines such as Galgeunhaegitang based on the results, stating, "The acts of diagnosing patients' growth plate status, growth retardation, osteoporosis, etc., using the ultrasound device and prescribing herbal medicines based on this constitute 'medical acts' under the Medical Service Act."

At that time, the Constitutional Court stated, "Licensed medical acts for Korean medicine doctors are Korean medical acts. Our Medical Service Act and related laws distinguish between Western and Korean medicine medical fields, prohibiting and punishing medical acts beyond the licensed scope for each, but do not provide specific regulations on whether certain medical acts are permitted or prohibited. Therefore, whether a specific act constitutes a Korean medical act should be judged comprehensively considering the nature and purpose of the medical act, academic basis, level of professional knowledge education, and related regulations," presenting judgment criteria.

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

Dissenting Opinions and Significance of This Ruling... Not Contrary to Previous Constitutional Court Decisions

On the other hand, Justices Ahn Cheol-sang and Lee Dong-won dissented, stating, "Our medical system adopts a dualistic principle strictly separating Western and Korean medicine, and the Medical Service Act grants licenses separately to doctors and Korean medicine doctors. Therefore, if a Korean medicine doctor uses an ultrasound diagnostic device by Western medical methods, it violates the dual medical system and constitutes unlicensed medical practice under the Medical Service Act."

The two justices added, "Even if the necessity of allowing Korean medicine doctors to use ultrasound diagnostic devices is recognized, it is desirable to resolve this institutionally and legislatively in a way that protects and promotes public health. Until such institutional and legal arrangements are made, regulating the use of ultrasound diagnostic devices by Korean medicine doctors as unlicensed medical practice is inevitable."

Regarding the significance of this ruling, a Supreme Court official said, "This full bench ruling is significant in that it presents 'new standards' regarding whether the use of diagnostic medical devices by Korean medicine doctors constitutes unlicensed medical practice, considering the variability of medical acts, scientific and technological advancements, changes in education curricula and national examinations, and the reasonable choice possibility of medical consumers."

The official also stated, "This ruling confirms that a qualified Korean medicine doctor cannot be held criminally liable for violating the Medical Service Act for using ultrasound diagnostic devices, products of modern scientific and technological development, as auxiliary means for Korean medical diagnosis to improve diagnostic accuracy and safety." However, the official cautioned, "This ruling does not imply that Korean medicine doctors are allowed to use all modern medical devices regardless of invasiveness. Also, this ruling should not be interpreted as denying the dual medical system stipulated in the Medical Service Act."

Meanwhile, regarding the previous Constitutional Court decision that judged the use of ultrasound diagnostic devices by Korean medicine doctors as a violation of the Medical Service Act, the court pointed out, "Although the Constitutional Court ruled in 2012 that the use of ultrasound diagnostic devices by Korean medicine doctors constituted unlicensed medical practice, compared to then, the education system and curriculum that form the basis for enhancing the expertise of medical acts related to the use of diagnostic medical devices in Korean medicine colleges have been continuously supplemented and strengthened."

The Supreme Court official added, "The Constitutional Court's rulings on constitutionality or dismissal of constitutional complaints do not have binding force. Moreover, the Constitutional Court declared that the interpretation of Article 27(1) of the Medical Service Act regarding 'medical acts beyond the licensed scope' for Korean medicine doctors should focus on protecting and promoting public health and granting usage rights to qualified medical professionals if diagnostic devices have significantly improved performance through scientific and technological advancements without health and hygiene risks. Therefore, the intent of this Supreme Court full bench ruling does not conflict with the Constitutional Court's decisions."

Under the Constitutional Court Act, rulings on unconstitutionality or acceptance of constitutional complaints have binding force, but rulings dismissing constitutional complaints do not. Therefore, even if the Constitutional Court expressed the above position in dismissing a constitutional complaint requesting the cancellation of the prosecutor's non-prosecution disposition for medical law violations by the complainants, it does not bind state agencies or others.

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