運用大數據於醫學診療的民事責任上的注意義務

The Legal Obligations in Applying Big Data to Medical Diagnosis and Treatment

人類仰賴與運用大數據於風險評估的預測能力日趨重要，例如商業大數據對於金融穩定有不可磨滅的功勞；美國醫學界對於早期發現疾病、預測癌症或疾病的復發，都處處顯示大數據的重要性。近年來，醫師運用大數據於診斷或治療的民事糾紛，以產檢大數據為主。在實務上，處理產檢大數據的醫療糾紛，未能真正將生技公司對於「蒐集端」及「管理端」的商品製造人責任的「非醫療行為」與「應用端」的醫療機構、醫師、醫檢師責任的「醫療行為」區隔出來；前者有消費者保護法的適用，而後者則無。因此，澈底明瞭與運用大數據，已經成為今日醫學界及法學界共同的標竿。倘若大數據的偵測結果不準確，非源於病人的特殊體質，病人可以依兩種法學理論來作為請求權基礎：一、依契約責任，乃基於誠實信賴原則：縱使無醫療過失，但是此告知說明為從給付義務，可以獨立訴請履行。二、依侵權責任，是屬於風險分配理論：未盡告知說明義務時，病患的同意原則上不生效力，不阻卻違法，但是如果最終沒有造成病人損害，則不成立侵權行為。兩者的請求權基礎有諸多不同，本文亦有詳細論述。大數據在醫學診療日益蓬勃發展的現況，本文提出台灣生技公司引進大數據電腦軟體及醫師運用大數據時，所應注意的法律義務，以期增進民眾福祉。

The ability of human beings to rely on and use big data to predict risk assessment is becoming important gradually. For example, commercial big data has an indelible contribution to financial stability. The American medical community has revealed the importance of big data everywhere in the early detection of diseases and prediction of cancer or disease recurrence. In recent years, mainly civil disputes for physicians who have used big data for diagnosis or treatment based on obstetrics. In court decision which was handling of medical disputes over big data in obstetrics and inspections has failed to truly distinguish between the“non-medical behavior”which belongs to product manufacturer of biotechnology company duty on the“collection side”with“management side”rather than“medical behavior”that belongs to the medical institutions and physician duty on“application side”. The former has the application of Consumer Protection Act, while the latter does not. Therefore, the clear understanding and application of big data have become the common benchmark of current medical and legal circles.