Medical technology, including diagnostic technology, has been developed in rapid pace nowadays; therefore, new health related activities in the healthcare area other than traditional medical practices may occur. For instance, a smart watch enabling to measure the heart rate would be classified as medical diagnostic equipment and thus should have obtained a regulatory approval before launching.

Kim Sun-Wook, esq. and Kim Young-Jun, esq.

Under the circumstances, a failure to realize that a smart watch enabling to measure the heart rate would be classified as medical diagnostic equipment at the time of inventing such smartwatch as well as a failure to obtain a relevant regulatory approval created a problem immediately before launching such smart watch to the market. To coup such problem, the Korean Government rushed to arrange for a guideline to exclude said smart watch enabling to measure the heart rate from the medical diagnostic equipment classification.

It is a good example showing that the rigorous legal system and fast evolving technology have consistently created legal problems. The reason behind such problems may be attributed to the legal interpretation of Korean laws finding that any activities likely creating harm to human health should be defined as medical practices. Under the circumstances, any individual or entity unlicensed to practice has no option but to take a very cautious approach whenever he/she or it engages in a new type of healthcare-related business.

It is because the legality or legitimacy of a new typed activity will be determined only after obtaining a courts’ judgment on whether such new typed activity may be classified as an unlicensed medical practice invoking a criminal sanction under the Medical Service Act. Accordingly, a new typed activity or any business based on such new typed activity may not be explored or realized into a business in the absence of any similar legal precedents.

In early 2000, for instance, the Korean Prosecution Office made its determination stating that the DNA analysis of a human hair was deemed a medical practice and thus that only a medical person is permitted to conduct this DNA analysis or engage in a business related to this DNA analysis. As a result, any business evolving from such DNA analysis was not permitted to pursue any further. Moreover, in early 2000, Korean communication or IT companies had actively engaged in developing a telemedicine system.

However, due to a finding that such telemedicine would constitute a medical practice, any person or entity ineligible for providing medical service was not able to pursue any further as well. In Korea, other than a medical person or a non-profit entity a license to practice the medical service is not granted to a usual business entity. Since said telemedicine would not be realized into a business, Korean companies dropped their plans to pursue any further. Such unfortunate incident from the business perspective would be attributable to the legal interpretation of medical practices unilaterally favorable to a medical person.

By taking a balancing approach, the Korean Government opened the DNA analysis related to taste or food-habit irrelevant to diseases to the public in 2016. On the other hand, the relevant industry has persistently attempted to analyze DNA using big data or high-level computer technology.

As illustrated hereunder, the National Health Insurance System in Korea has been played as an additional obstacle. For the purpose of application of a newly developed medical technology to the medical environment, such newly developed medical technology should be incorporated into the framework of the National Health Insurance System.

Since such incorporation inevitably causes a spending of the finance for the National Health Insurance, as a part of conservation efforts of the finance for the National Health Insurance, it may be an extremely rare case that a newly developed medical technology is to be applied to the medical environment. Moreover, it is also illegal to implement a new technology other than medical treatment recognized under the National Health Insurance in sole reliance of a patient’s consent. It is further held illegal to be paid medical fees from a patient in consideration of using a newly developed medical technology not incorporated into the National Health Insurance System.

In the end, all the above has played as significant obstacles to development and application of a new typed medical practice.

Penalty against unlicensed medical practice

Under Korean laws, a legal liability imposed on an unlicensed medical practice may be divided into i) a criminal sanction, ii) an administrative disposition such as suspension of the physician’s license or iii) a civil liability. The criminal penalty against an unlicensed medical practice was originally introduced to police any medical practice performed by any unauthorized person.

In addition to the statutory provision to penalize any unlicensed medical practice under the Medical Service Act, Korea also enacted ‘the Act on Special Measures for Control of Public Health Crimes’ to enforce an aggravated punishment against the systematic and business scale undertaking of unlicensed medical practices. Although the Act permits the punishment in the form of a fine against a certain case, ‘the Act on Special Measures for Control of Public Health Crimes’ permits aggravated criminal sanctions of the concurrent punishment of an imprisonment as well as a fine.

Such penalties have distinct characteristics to punish any and all medical practices without legitimate licenses not just merely to punish any medical practices causing personal injuries to a patient or harm to a patient’s health. On the other hand, nowadays the provision related to policing unlicensed medical practices has been more commonly used to punish a medical doctor(s), who caused and/or aided or abetted a nurse(s) or assistant nurse(s) working in a hospital(s) to perform unlicensed medical practices in violation of relevant laws in addition to a punishment of any unlicensed person.

It has been reported that the provision related to policing unlicensed medical practices in the health and medical system has drawn the most attention regarding petitions submitted to the Korean Constitutional Court for the purpose of seeking the Court’s judgment regarding whether such statutory provision is constitutional. Nevertheless, the Korean Constitutional Court has consistently rendered its judgment that the provision related to prohibiting unlicensed medical practices well conforms to the Korean Constitution.

Upon the occurrence of a medical accident(s), the Korean court presumes a malpractice(s) in the course of a civil proceeding to seek damages while damages arising from any unlicensed practices may not lead to any aggravated liability compared to those resulting from any general medical accidents. Any civil proceeding seeking damages arising from any typed medical accidents does not lead to the Court’s awarding punitive damages in Korea.

KIM & HYUN (SeSeung LLC). All rights reserved. Further duplication without permission is prohibited. For more information, please email to swkim@sslaw.kr (Kim Sun-wook) or yjkim@sslaw.kr (Kim Young-jun).

swkim@sslaw.kr

<© Korea Biomedical Review, All rights reserved.>