• 한국IT서비스학회지
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• 제22권4호
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• pp.21-35
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• 2023

Software as Medical Devices (SaMD) is a growing category of medical devices that are composed of software to perform one or more medical purposes. SaMD is less likely to cause physical harm compared to conventional medical devices, particularly medical electrical equipments, and may be more vulnerable to privacy issues. This difference was acknowledged and resulted in introducing new regulation guidance specifically for cybersecurity of SaMD. It guides stakeholders of SaMD what to consider in what context in terms of cybersecurity. This study examines the current guidance of how cybersecurity is considered for SaMD by analyzing current medical device standards, then suggest which concept or details beyond current medical device standards may be applicable through analysis of international standards documents published for software in general.

• 대한의용생체공학회:의공학회지
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• 제42권6호
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• pp.277-286
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• 2021

The global market size of AI based SaMD for medical image in 2023 will be anticipated to reach around 620 billion won (518 million dollars). In order for Korean manufacturers to efficiently obtain CE marking for marketing in the EU countries, the paper is to introduce the recommendation and suggestion of how to reclassify SaMD based on classification rules of MDR because, after introducing the Regulation EU 2017/745, classification rules are quite modified and newly added compared to the Directive 93/42/EEC. In addition, the paper is to provide several rules of MDR that may be applicable to decide the classification of SaMD. Lastly, the paper is to examine and demonstrate various secondary data supported by qualitative data because the paper focuses on the suggestion and recommendation with a public trust on the basis of various secondary data conducted by the analysis of field data. In conclusion, the paper found that the previous classification of SaMD followed by the rule of MDD should be reclassified based on the Regulation EU 2017/745. Therefore, the suggestion and recommendation are useful for Korean manufacturers to comprehend the classification of SaMD for marketing in the EU countries.

• 대한의용생체공학회:의공학회지
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• 제44권6호
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• pp.428-442
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• 2023

In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

• 한국빅데이터학회지
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• 제8권1호
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• pp.111-129
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• 2023

디지털 혁신의 확산에 따라 의료 분야에서도 인공지능을 기반으로 한 혁신의료기술의 채택이 활발해지고 있다. 이에 따라 인공지능 기반 소프트웨어형 의료기기인 SaMD(Software as a Medical Device)의 출시 및 도입도 촉진되고 있지만, 의료기관의 SaMD 도입 요인에 대한 연구는 미흡한 편이다. 본 연구의 목적은 '인공지능 기반 SaMD' 도입에 대한 의료기관의 의사결정에 영향을 미치는 중요한 요인들을 찾고, 이들 요인의 가중치와 우선순위를 분석하는 것이다. 이를 위해 의료계의 기술수용 모델, 의료 인공지능 및 SaMD 등에 관한 문헌연구 결과를 바탕으로 델파이 조사를 실시하였으며, HOTE(Human, Organization, Technology and Environment) 프레임워크와 HABIO(Holistic Approach {Business, Information, Organizational}) 프레임워크를 결합하여 연구 모형을 개발하였다. 5가지 주기준과 22개의 하부기준으로 구성된 연구 모형을 바탕으로 국내 의료기관과 SaMD 공급자의 전문가들을 대상으로 AHP(Analytic Hierarchy Process) 분석을 실시하여 SaMD 도입 요인을 실증적으로 분석하였다. 본 연구의 결과, 인공지능 기반의 SaMD 도입을 결정하는 주기준의 우선순위는 기술적 요인, 경제적 요인, 인적 요인, 조직적 요인, 환경적 요인의 순으로 나타났고, 하부기준의 우선순위는 신뢰성, 진료원가 절감, 의료진의 수용도, 안전성, 최고 경영자의 지원, 보안성, 인허가 및 규제 수준의 순이었다. 특히, 신뢰성, 안전성, 보안성 등의 기술적 요인이 SaMD 도입에 있어서 가장 중요한 것으로 나타났다. 또한, 각 집단별 가중치와 우선순위를 비교·분석한 결과, SaMD 도입 요인의 가중치와 우선순위는 기관의 유형, 의료기관의 유형 및 의료기관 보직의 유형에 따라 매우 다른 것으로 나타났다.

• 대한의용생체공학회:의공학회지
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• 제44권4호
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• pp.264-274
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• 2023

Purpose: The objective is to extract insights that can contribute to the formulation of harmonized international policies and support measures for innovative medical devices and management systems. This study aims to propose effective strategies for future medical device innovation and healthcare delivery. Results: It investigates technological advancements, regulatory approval systems, insurance policies, and successful commercialization cases in South Korea, the United States, and the European Union. In 2018, the FDA implemented insurance coverage for Software as a Medical Device (SaMD) and recognized insurance coverage for Digital Therapeutics (DTx). Germany is a country that ensures permanent reimbursement for healthcare applications since 2020, making it the first country to provide legal health insurance coverage for fostering a digital ecosystem. Conclusion: The findings of this research highlight the importance of cultivating a supportive regulatory and environmental framework to facilitate the adoption of innovative medical devices. Continuous support for research and development (R&D) efforts by companies, along with the validation of clinical effectiveness, is crucial.

• 구강회복응용과학지
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• 제36권4호
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• pp.203-210
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• 2020

현대사회는 4차 산업혁명 시대를 맞아 정보통신기술의 발달로 환자 개인 맞춤 의료서비스가 확대되고있다. 이러한 변화에 따라 질병의 진단, 환자 감시, 의사결정 지원에 디지털 의료기기가 활용되기 시작했으며 최근엔 장애나 질병예방, 관리 또는 치료하기 위한 목적의 소프트웨어 의료기기가 각광받고 있다. 본 종설은 현재 미국을 중심으로 활발하게 이뤄지고 있는 치료 목적의 소프트웨어에 대한 개념과 현황을 파악하고 앞으로 어떤 분야에서 적용될 수 있는지 알아보고자 한다. 또, 스마트 헬스케어와 관련된 국내 정책 동향을 파악해 다가올 의료계의 변화에 발맞춰 치과 임상에서 가능한 디지털기반 소프트웨어 의료기기의 적용에 대해 알아보고자 한다.