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KMID : 0986720230310020217
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Korean Journal of Medicine and Law
2023 Volume.31 No. 2 p.217 ~ p.239
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A Study on the Legislative Direction of Digital Healthcare - Focusing on the digital healthcare regulations in USA -
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Kim Jae-Sun
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Abstract
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“But I do think, looking back, in the future, you will answer that question: Apple's most important contribution to mankind has been in health.” In 2019, Apple CEO Tim Cook publicly declared Apple's willingness to expand its services to health and medical fields, and since then, Google and Meta have also expanded their scope to health-related services based on the data they have already collected, various forms of digital healthcare centered on technology companies are developing.
As the digital healthcare area develops rapidly, it is difficult to predict a clear legal system in advance, and it is difficult to present a specific direction legislatively. In addition to securing the right to know, health care, and safety of medical practice, there is also a great need to utilize evolving technologies to the benefit of humans and the people. Therefore, it is necessary to objectively consider whether the value of technological innovation will benefit the data subject and even the people, and whether the expected benefit is greater than the possibility and degree of risk of infringement. It is necessary to objectively consider whether the "autonomy, bargaining power, fairness, and dignity" between the main actors, the "data subject, medical industry, and government," and to agree on the desirable direction of institutional design based on respect and trust. Accordingly, it is necessary to prepare the following legislative principles in the sentence of profit necessary for digital healthcare legislation.
First, it examines the utility of the public interest according to the degree of risk. First of all, (1) the classification and legal definition of a series of actions from health care services to medical practices that differ in the applicable laws for each area should be clarified, and (2) the necessity of legislative action should be discussed through profit penalties for each definition area. For example, efforts to improve medical services by using low risk and technology or to actively improve legal systems in areas where meaningful development is expected, such as the development of treatment methods and treatments, are required. In addition, for areas with high risk, high utility, low risk, and low utility, it is necessary to check the safety of services, protect medical information, protect the rights of data subjects, and respect medical staff's professional judgment based on the review of the current legislation and empirical and objective review.
Second, it is required to cultivate experts in new technology evaluation and to give trust in expert judgment. Safety and risk assessment from the use of technology is judged to be "reasonably serious to have serious adverse health issues", and the manufacturer-centered pre-certification system or service-centered post-review system is judged through expert opinions and deliberations. In the digital health area, the preliminary review process will be eased when medical device properties are not recognized, and if expert consensus is reached through sufficient review in the low-risk area, it will be possible to use it with trust, but the post-verification and review system will be strictly operated. As a premise for this, it is necessary to internationalize and modernize the deliberation standards and to sufficiently review and judge in a timely manner so that the types of services such as new medical technology and mobile applications and the possibility of risk occurrence can be evaluated.
Third, the limited area of infringement of basic rights should be clarified. Digital healthcare is used to promote health and medical benefits, but it is necessary to clearly interpret the limitations for infringement of basic rights. In the case of the United States, the federal and states stipulate the laws of protection of basic rights to digital transformation in the Genetic Information Discrimination Act, the Disabled Person Act, the Employment Discrimination Act, and the Consumer Data Protection Act. It is necessary to respect the laws of protection of basic rights defined in each law in the sentence of profit on value.
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KEYWORD
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Digital Healthcare, Legislative Balancing, Information Subject, Healthcare, Medical Practice, Risk
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FullTexts / Linksout information
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