[Contribution] Strategic inflection point for healthcare companies after the implementation of the AI Framework Act
Beyond compliance with permits 'Medical Justice Risk' Towards the Age of Management Law Firm(finite) Attorney Daeryun Lee Seo-hyung Basic Act on Development of Artificial Intelligence and Creation of Trust Foundation, etc.(below AI basic law)Since its implementation, the pharmaceutical, bio, and digital healthcare industries have been freed from regulatory uncertainty to some extent.. High impact directly related to life and health as the government considers promoting the healthcare industry and promoting innovation AIThis is because the scope of application is interpreted flexibly and regulations are relatively limited for diagnostic assistance solutions that require the intervention of medical professionals such as doctors or pharmacists.. This policy approach is a reasonable measure to maintain the momentum of digital healthcare technology development.. In particular, through the Digital Medical Products Act, which was implemented in earnest, software medical devices(SaMD) The administrative regulatory system in the healthcare field is also firmly established, with a customized Ministry of Food and Drug Safety approval track in operation.. However, stabilization of this regulatory environment does not mean resolution of legal risks.. rather medical AIIt is highly likely that the judicial responsibility of will be put to the test in earnest from now on.. ◆ The legal gap between formal intervention and actual control in clinical settings Some digital healthcare companies are AI High impact by requiring approval from medical staff or pharmacists at the final stage of the solution AI You may want to cross the regulatory threshold. However, if a medical dispute arises and becomes the subject of a court decision,, The focus is 'Presence of medical intervention'Rather, the intervention is directly related to the patient's life. 'Practical clinical control capabilities'It depends on whether you performed. For example, early diagnosis of cancer AILet's assume that a malignant tumor is misdiagnosed due to failure to sufficiently learn data from female patients of a certain age, or that the anticancer drug dosage recommendation algorithm underestimates liver function values, resulting in serious side effects.. In this case, the court simply 'Did the medical staff press the final approval button?' do not check whether. corresponding AIHas clinical evidence and explanatory potential been provided at a level that medical staff can reasonably review?, We will comprehensively determine whether a control system to cross-verify algorithmic bias and errors exists within the company.. If the system is designed so that the approval process is carried out mechanically without substantive verification without considering the characteristics of busy clinical sites, the so-called human intervention can be reversed evaluated as a situation that shows a fatal flaw in the product safety management system, not as a logic of immunity for healthcare companies.. This can be expanded to governance risk, where the issue is whether management has established and supervised a reasonable internal control system.. If serious patient harm occurs, We cannot rule out the possibility that this could lead to shareholder lawsuits or violations of the board of directors’ supervisory duties.. ◆ Global Big Pharma Partnership and Overseas B2B A new standard in the market 2026Year now, EU AI Act(artificial intelligence law)With the full-scale application of AI Demanding governance. Global multinational pharmaceutical company(Big Pharma)I large medical institutions K-When discussing new drug material technology export or joint clinical contracts with healthcare companies, We do not simply ask whether the guidelines of the Korean Ministry of Food and Drug Safety are followed.. Legality of sensitive patient medical data used for training, Transparency of prediction algorithm, There is a trend to request specific data to prove the company-wide bioethics control system.. The only reason domestic regulations can be avoided is through strict overseas partners or regulatory agencies.(FDA, EMA etc.)It is not a sufficient explanation for. rather internal medical AI When the governance system is insufficient, Exclusion from the global healthcare supply chain as well as highly contractual representations and warranties(Representations & Warranties) May lead to acceptance of provisions. Now in the pharmaceutical and healthcare industries AI Governance is an absolute prerequisite for global market access. ◆ post AI Challenges for healthcare companies in the era of basic laws Pharmaceutical, bio and digital healthcare companies must abandon the defensive approach of avoiding regulations and shift to a strategy of securing sustainable competitiveness based on patient safety and trust.. Reactive response after a problem occurs is a cost, but establishing a control system at the design stage is close to a strategic investment that protects corporate value.. To this end, we propose the following tasks:. ① Systematization of demonstrable medical responsibility by medical staff or researchers at clinical sites AI Review the results and, Process modified or rejected when necessary based on medical judgment EMR(Electronic medical record)However, an audit log that is systematically recorded in the clinical research system must be established from the product planning stage.. This will be a key defense tool to prove that companies and management have fulfilled their duty of reasonable care in future medical disputes or shareholder lawsuits due to clinical failures.. ② medical treatment AI Reorganize the contract structure for the entire value chain. Use external foundation models or use external foundation models in hospitals and pharmacies to develop new drugs and digital treatment devices. AI When delivering a solution, risks must be made clear.. technical glitch, misdiagnosis, How will responsibility for sensitive medical data leaks be distributed?, A sophisticated risk allocation contract structure between the solution provider and the introducing institution, such as a hospital, is essential.. ③ Patient safety comes first Compliance by Design Establishing a system In a healthcare company that deals with life AI Risk is specific IT It is not just a development department issue, but a company-wide governance issue that will determine the survival of the company.. Department of Medicine from the beginning of pipeline planning and solution development(Medical Affairs), License(RA), legal, A governance structure that establishes a control system in which the information security department participates and manages it as a key agenda at the board level is required.. ◆ Beyond the illusion of legality, the government's flexible interpretation of regulations with a premium on patient trust has provided healthcare companies with a golden time for technological innovation., It does not relieve the strict obligation to manage risks directly related to the patient's life.. 2026year AI basic law era, K-The true competitiveness of bio and digital healthcare does not come from narrowly crossing the boundaries of licensing and regulation.. Transparent and verifiable healthcare AI Only companies that proactively establish governance can be evaluated by global partners and patients as a partner they can trust with their life and health.. solid AI Governance is not a sunk cost, but the best strategic capital allocation that protects the intrinsic value of the company and patient safety.. AI The challenges facing the healthcare ecosystem after the implementation of the Basic Act are clear.. Legal is only the minimum standard. Patient trust is not gained through licensing, but rather through what controls and records a company has in moments of conflict., It is proven that a responsibility structure was in place.. |contribution| law firm(finite) Attorney Daeryun Lee Seo-hyung [View full article]
[Contribution] Strategic inflection point for healthcare companies after the implementation of the AI Framework Act (Go here)