Press Coverage

Providing comprehensive risk management solutions including corporate disaster management... ‘Securing business continuity’ Daeryun “We will become a strong partner for corporate customer growth through cooperation with experts” Daeryun Law Firm announced on the 21st that it signed a three-party MOU with Korea Continuity Research Institute Co., Ltd. and Korea Corporate Disaster Management Association to strengthen corporate disaster management and legal risk response. At the signing ceremony held at the Daeryun Seoul headquarters branch office on August 19, Daeryun Law Firm Management CEO Kim Kuk-il, CEO Choi Yi-seon, lawyer Son Gye-jun, Korea Continuity Research Institute and Korea Corporate Disaster Management Association CEO and Chairman Yang Jun, Vice Chairman Jang Ho-jin, and Director Park Jong-pil attended. Korea Continuity Research Institute Co., Ltd. is an organization that provides professional consulting and education for corporate business continuity, including corporate disaster management (BCMS), major civil disaster response consulting, risk assessment, and recovery strategy establishment. In particular, it helps maintain corporate operations along with immediate damage recovery in the event of a disaster, and has strengths in document work as well as establishing a practical disaster response system. The Korea Corporate Disaster Management Association is a professional organization that strengthens the capabilities of the ‘Corporate Disaster Manager’, a national professional qualification of the Ministry of the Interior and Safety, and establishes the ‘Corporate Disaster Mitigation Activities’ system, and is working to establish a policy and institutional foundation to revitalize the ‘Act on Support for Corporate Autonomous Activities for Disaster Reduction’. With this MOU, Daeryun plans to provide comprehensive risk management solutions, including corporate disaster management, and promote the development of an integrated consulting model to secure corporate business continuity. Specifically, it plans to ▲ strengthen the legal basis and risk response system for the corporate disaster management consulting process, ▲ jointly provide legal advice on the Severe Accident Punishment Act and disaster reduction activities, and ▲ assist in joint bidding for large corporations and public institutions by holding joint seminars and training. Yangjun, Korea Continuity Research Institute Co., Ltd. The CEO said, “This MOU is meaningful in establishing a system that operates in the event of an actual disaster, not just a document,” and “We will create a market where talented disaster management experts are recognized.” Kim Kuk-il, CEO of Daeryun Law Firm, said, “Through cooperation with corporate disaster management experts, Daeryun will become the strongest legal partner for the growth of corporate clients.” He added, “By combining Daeryun’s one-firm system and their expertise, we will create synergy that goes beyond the limitations of the existing market.” “We will create it,” he emphasized. Meanwhile, Daeryun Law Firm is helping major domestic companies achieve stable growth by providing advice on the Severe Accident Punishment Act, criminal response to industrial accidents, and corporate risk consulting related to information leakage incidents. Reporter Son Dong-wook, Lawleader, twson@lawleader.co.kr Law Leader - Daeryun Law Firm, MOU with Korea Continuity Institute and Korea Corporate Disaster Management Association (Click here) Money Today - Strategic three-party MOU with Korea Corporate Disaster Management Association and Daeryun Law Firm-KCI (Click here)

Daeryun Law Firm announced on the 21st that it will hold the ‘2025 Commercial Act Revision and Yellow Envelope Act Response Strategy Seminar’ at its Seoul headquarters branch office on September 3. This seminar was prepared to preemptively prepare for the labor-management relations and corporate governance environment that will change depending on changes in laws. On the 3rd of last month, a bill to amend the Commercial Act, which aims to expand directors' duty of loyalty and improve corporate governance, was passed by the National Assembly. This amendment also includes strengthening the independent director system, introducing an electronic general meeting of shareholders, and strengthening the 3% rule, so companies are busy responding to this. In addition, Articles 2 and 3 of the Labor Union Act, the so-called ‘Yellow Envelope Act’, which contains contents such as limiting companies’ claims for compensation and expanding collective bargaining matters, are also scheduled to be processed at the extraordinary plenary session of the National Assembly this month. It is expected to bring about significant changes in labor-management relations along with the corporate management environment, so it is necessary to prepare response strategies after the law is enforced. At the seminar, attorneys Ho Gyu-chan (36th class of the Judicial Research and Training Institute) and Bang In-tae (41st class of the Judicial Research and Training Institute) from Daeryun Corporate Legal Group will appear as presenters. Attorney Bang, a labor lawyer registered with the Korean Bar Association and well-versed in legal advice in the human resources and labor areas of companies, will give a presentation on the main contents and prospects of the Yellow Envelope Act. Attorney Ho explains the key issues and implications of the amendment to the Commercial Act. While working in the Commercial Law Department of the Ministry of Justice, Attorney Ho participated in the revision of the corporate section of the Commercial Act, and later served as an advisor on corporate governance and financial law to law firms and financial institutions. After the presentation, the two lawyers plan to conduct a Q&A and discuss practical responses to major issues. The seminar will be held simultaneously online and offline, and anyone can apply for free. Applications for participation can be made on the Daeryun official website. Kim Kuk-il, CEO of Daeryun Management, said, "The Yellow Envelope Act and the amendment to the Commercial Act are important issues that can simultaneously bring new risks and opportunities to companies' labor-management relations strategies, governance structures, and overall operating methods. I hope that this seminar will help companies review their response strategies and establish practical directions." Meanwhile, Daeryun focuses on corporate legal groups and provides customized legal services for companies such as labor re-transfer, collective bargaining, and board consulting. We are providing services, and we have recently formed a task force in response to the amendment to the Commercial Act to support the preparation of strategic countermeasures.. Reporter Jeong Cheol-wook, Busan[View full article] Seoul Shinmun - Daeryun Law Firm holds ‘Commercial Act Revision and Yellow Envelope Act Response Strategy Seminar’ (Go here) Blotter - [Law Firm ON] Daeryun holds ‘Commercial Act Amendment and Yellow Envelope Act Response Strategy Seminar’ (Go here) Tax Ilbo - Daeryun Law Firm holds ‘Commercial Act Revision and No-Severe Act Response Strategy Seminar’ (Go here) Law Leader - Daeryun Law Firm holds ‘Commercial Act Amendment and Yellow Envelope Act Response Strategy Seminar’ (Go here)

A franchisee who was accused of publicly criticizing a franchise owner was acquitted in the first trial and also in the appeal trial. The 4th Criminal Division of the Daegu District Court dismissed the prosecution's appeal and upheld the original trial ruling that acquitted Mr. A, a man in his 40s who was indicted on defamation charges, on the 9th of last month. In 2022, Mr. A said, “Mr. B, one of the franchise owners, intentionally failed to repay his debt and was even punished criminally.” He was accused of spreading the information to other franchise owners. Mr. B, who heard this from other store owners, filed a complaint against Mr. A, and the investigation began. Mr. A denied the charges. Mr. B was violating the franchise agreement by purchasing materials through external companies other than those designated by the head office, and claimed that the problem arose by introducing these external companies to other store owners. He emphasized that he only met with the franchise owners to discuss the matter and did not make any defamatory remarks. Based on the statements of the franchise owners, the prosecution determined that Mr. A was guilty and requested a summary order of a fine of 2 million won. Afterwards, a court order was issued, but Mr. A, who refused to comply, requested a formal trial. The first trial court declared him not guilty. The court said, "The part where the victim heard the defendant's remarks from the franchise owners is nothing more than a report containing a repeat statement, so it has no evidence," and added, "The only evidence that could be consistent with the indictment is the store owners' statements that they heard the remarks directly from the defendant." However, "the statement of the store owners is different from what is stated in the indictment, so it is not confirmed that the defendant made the remarks." He added, "The defendant and the store owners are going through a legal dispute, so their “It is difficult to believe the statement as it is,” he added. The prosecution, which objected to this, filed an appeal on the grounds of misconception of facts. However, the appellate court also upheld the not guilty verdict, saying that there were no reasonable circumstances to consider the original trial's judgment unfair. Attorney Jeon Hyeong-oh of the Daeryun Law Firm, who represented Mr. A, explained, "During the investigation, the store owners were unable to properly answer the contents of their testimony or their statements conflicted with each other. We emphasized that their statements were intended to punish Mr. A for his ill-feeling, and the court also accepted this and appears to have failed to recognize its credibility." Reporter Kwon Byeong-seok (bsk730@fnnews.com)[View full article] The business that publicly criticized the franchise owner was found not guilty in the appeal trial (link)

A decision was made not to forward a YouTuber who was being investigated by the police for posting a malicious home appliance review video. On the 14th of last month, Yuseong Police Station in Daejeon decided not to forward a man in his 40s, Mr. A, who is suspected of defamation under the Information and Communications Network Act. This year, Mr. A was accused of posting a video containing false facts related to the products of electronics company B on his YouTube channel. Company B claimed that Mr. A had exaggerated the defect rate of its products by inflating the actual rate. It was claimed that the cause of the defect was determined to be a manufacturing defect, unlike in reality. Mr. A denied the charge, saying that he had compared the defect rate with similar product lines through an actual investigation. In addition, the company name was not mentioned in the video, and the product was also mosaiced, so it was emphasized that the manufacturer of the product could not be identified as Company B. The police determined that Mr. A was not guilty. The police said, "The content contained in the video is based on the suspect's own investigation as well as the results of experiments by private companies and researchers. He said, "The suspect requested Company A to make improvements in this regard, but the company ignored them. In the long term, it appears that Company A also needs to inspect or correct the cause of the defect rate." He also explained the reason for the decision to not forward the video, saying, "The suspect posted the video because it was created based on evidence for the purpose of public interest, not to slander Company A, so there was a perception that it was false." Attorney Cho Sang-soo of Daeryun Law Firm, who represented Mr. A, said. “Article 310 of the Criminal Act stipulates that illegality arises if the facts stated are true and solely for the public interest,” he said. “We emphasized that consumer complaints have been filed with Mr. A, who is recognized in the home appliance industry and has many subscribers, and that we have produced a video based on these to prevent damage.” Go Woori (wego@ikbc.co.kr)[View full article] Posted a false review?... YouTuber booked for 'defamation', acquitted (Click here)

Many drivers experience retaliatory driving and reckless driving on the road. However, there are not many cases where the difference between the two terms is clearly known. Reckless driving is a crime under the Road Traffic Act and is an act that poses a threat to an unspecified number of people. It occurs when two or more of the nine acts, such as violating a traffic signal or crossing the center line, are committed consecutively or one act is repeated, and can be punished by imprisonment for up to one year or a fine of up to 5 million won. On the other hand, retaliatory driving is a special crime under the criminal law and is an act of intimidation targeting a specific person. A single act is enough, and as a car is recognized as a 'dangerous object', special injuries (imprisonment for 1 to 10 years), special threats (imprisonment for 7 years or less or a fine not exceeding 10 million won), and special assaults (imprisonment for up to 5 years or a fine not exceeding 10 million won) are applied. However, for a retaliatory driving charge to be established, objective circumstances such as intentionality, persistence, repetition, and creating fear in the victim are required. Everything must be proven. Even if you honked your horn for a long time simply because you were in a bad mood, or changed lanes quickly without a turn signal, charges may not be established if there was no clear intent to threaten. A recent case I handled clearly shows the importance of concrete evidence. Client A, who worked as a bus driver, was booked on charges of special threats last year. Mr. A, who was driving in the bus-only lane at the time, tried to overtake the bus in front through the second lane on the right as it was traveling at a slow speed. However, the vehicle running in the next lane did not easily give space. Accordingly, Mr. A got behind the vehicle in question and flashed his high beam lights, and even crossed over into the second lane even after returning to the bus lane. After meeting the client, I carefully reviewed the circumstances of the incident. In particular, we examined whether Mr. A's actions met the requirements for retaliatory driving. As a result, it was determined that it was difficult to prove the ‘intention’ of retaliation in Mr. A’s actions. Mr. A claimed that at the time, he turned on his high beam as a signal to adjust his driving speed to the damaged vehicle. In addition, regarding the lane crossing, it was emphasized that it was a mistake that occurred while steering the steering wheel to avoid colliding with the median, and that it was not intentional. The prosecution also saw circumstances showing that Mr. A crossed the lane toward the victim and threatened the victim even though he entered the bus lane after flashing his high beam lights, but decided not to prosecute, saying that considering the extent of crossing the lane, it is difficult to consider it as intentional retaliation. As can be seen from this incident, there is an exact legal standard for retaliatory driving, which is a common behavior committed by drivers on the road. It is clearly different from conflict. Therefore, even if you are accused, you can avoid unfair punishment through systematic response. Above all, we must keep in mind that collecting early evidence and organizing facts are key factors that determine the outcome of a case. When you are subject to retaliatory driving on the road, it is important to keep a safe distance and not fight back. After securing evidence with a black box or mobile phone, report it to 112 or the Safety Report Center, and record the vehicle number, time, location, and specific threatening actions in detail. Attorney Lee Ha-neul of the Daeryun Law Firm said, “Conversely, if you have been identified as the perpetrator of retaliatory driving, it is more important to accurately determine the facts than hasty admission.” He added, “Retaliatory driving is a special crime that carries the possibility of imprisonment even for first-time offenders, so help from experts must be obtained from the initial investigation stage. Black box video, witness statements, and the situation at the time. He said, “It is more important than anything to find areas to dispute the charges by comprehensively reviewing the charges, and to lower the level of punishment through a sincere agreement with the victim. Also, it is more important to prevent such situations by making defensive driving a habit.” Global Epic CP Lee Soo-hwan / lsh@globalepic.co.kr Punishment for retaliatory driving is different from reckless driving... What the lawyer says are the establishment requirements (link)

A man in his 40s was sentenced to 1 year in prison for violating the Stalking Crime Punishment Act by demanding money as a hostage for threatening messages, phone calls, and body photos. Court said, “The number of offenses is not good... the victim suffers greatly.” A man in his 40s was sentenced to prison for threatening and stalking his ex-lover who broke up with him, saying, “I will not leave you alone.” According to the legal community on the 19th, the 2nd Criminal Division of the Ansan Branch of the Suwon District Court on the 17th of last month ruled on the ‘Act on the Punishment of Stalking Crimes, etc.’ Mr. A, in his 40s, who was accused of violating the law, was sentenced to one year in prison. In addition, he was also ordered to complete a 40-hour sexual violence and stalking treatment program. When Mr. A received notice of a breakup from Mr. B, his former lover, last year, Mr. A was put on trial on charges of stalking Mr. B by repeatedly texting and calling him about 130 times. He was also accused of demanding money by threatening to spread a photo of Mr. B's body parts. Mr. B requested severe punishment, saying that Mr. A's threats caused him long-term fear and anxiety and that he had difficulty in interpersonal relationships. Accordingly, the court sentenced Mr. A to one year in prison. The court said, "Considering the relationship between the two and the number of times the crime was committed, the nature of the defendant's crime was not good, and the victim suffered considerable mental pain," and "Although the defendant did it for the victim, “There was a criminal deposit (a system in which the perpetrator entrusts money to the court for the victim’s recovery), but considering the fact that the victim did not forgive, it is difficult to view this as equivalent to an agreement,” the ruling said. “Mr. A’s actions went beyond the emotional response of the breakup process and were a serious crime that seriously violated Mr. B’s right to self-determination,” he said. “During the trial, he emphasized that this was equivalent to or more than physical violence. “It appears that the court recognized the seriousness of the case and handed down a prison sentence.” Reporter Kim So-hyun (sovivid@kyeonggi.com)[View full article] “Threatened about 130 times in response to breakup notice”… 40-year-old sentenced to prison for stalking ex-lover (link)

Daeryun Law Firm recently formed a task force (TF) to preemptively respond to changes in corporate governance and the way the board of directors and general shareholders' meetings operate due to revisions to the Commercial Act. The TF focuses on accurately interpreting the purpose of legal revisions and providing customized advice optimized for a company's business structure and management environment. Accordingly, it deals in depth with all legal issues and practical areas related to the Commercial Act Amendment. The TF is comprised of lawyers with extensive practical experience in the fields of corporate advisory, governance of listed companies, mergers and acquisitions (M&A), contracts between shareholders, fair trade, and dispute prevention. The core members include attorneys Shin Jong-soo (31st class of the training center), Son Gye-jun (36th class), Ho Gyu-chan (36th class), Bang In-tae (41st class), and Ji Min-hee (bar exam 10th class). Attorney Ho said, "Daeryun has designed a compliance system that can be applied to actual management sites and supports the board of directors and general shareholders' operating procedures and decision-making process," and added, "Expansion of directors' duty of loyalty, strengthening of the independent director system, which are the core of the revised commercial law. “We analyze the impact that the introduction of an electronic general shareholders’ meeting will have on corporate management and present strategies to turn this into an opportunity,” he said. In this process, we diagnose the company’s risks and areas needing improvement, and provide a customized operation manual that reflects industry characteristics, governance status, shareholder composition, etc. to further differentiate ourselves. The TF is preparing online and offline seminars to understand the major issues and precedent trends of the amendment. We will also provide key information through our YouTube channel and newsletter. In particular, the newsletter is planned to be structured so that it can be used in the field by containing explanations of condolences, as well as actual dispute cases and precautions for practical application. Attorney Ho said, “There is a growing consensus among companies that a proactive design, rather than a reactive response to commercial law revisions is necessary,” and added, “This will be data that takes this trend into consideration.” In the short term, the TF plans to focus on supporting areas with significant changes, such as audit committee election regulations and independent director selection procedures. In the mid- to long-term, we are planning to expand integrated advisory services linked to environmental, social, and governance (ESG) and compliance systems. Daeryun said, "We will strive to provide on-site advice to help companies grow stably in a changing legal environment," and added, "We will prevent disputes that may arise after the implementation of the amendment and make the implementation of a governance structure that meets international standards our top priority." Reporter Park Seon-woo (closely@bloter.net)[View full article] [Commercial Law Amendment Law Firm Restaurant] Daeryun, analyzes corporate risks and turns them into opportunities (Shortcut)

Local government claims "violation of building laws through unauthorized expansion" Owner files suit for cancellation after administrative trial is dismissed Court rules in favor of plaintiff: "Corrective order should be revoked" A court ruled that if a local government failed to specify the target while issuing a corrective order for an unauthorized expansion building, the measure was illegal. It is judged to be a violation of the principle of clarity as the subject of correction is ambiguous. On the 23rd of last month, the 1st Administrative Department of the Gangneung Branch of the Chuncheon District Court ruled in favor of the plaintiff in the lawsuit filed by Mr. A against the local government to cancel the order to correct the violative building. Previously, Mr. A's spouse purchased a neighborhood living facility in Gangneung, Gangwon-do in December 2003 and completed the registration of transfer of ownership. Afterwards, the spouse passed away and Mr. A received the inheritance. In February of last year, the local government ordered the building to be restored to its original state, saying it was acknowledged that the building had been expanded without permission and violated building laws. Accordingly, Mr. A filed an administrative appeal to cancel the correction order, but it was dismissed, and he later filed an administrative lawsuit. During the lawsuit, Mr. A claimed that he had never committed any illegal acts, such as expansion, in relation to the building in question. In particular, he emphasized that although more than 20 years had passed since the purchase of the building, the local government had not once raised an issue during this period. The first trial dismissed Mr. A's claim, finding that the local government's corrective order was justified. The first trial court stated, “Considering the legislative purpose of the Building Act, which aims to contribute to the promotion of public welfare by improving the safety, function, environment, and aesthetics of buildings, it is judged that the public interest sought to be achieved is greater than the private interest infringed by the disposition of this case.” However, the appellate court judgment was different. The appellate court ruled, “The disposition in this case does not specifically state the area and location occupied by the unauthorized extension of the building, the date and type of violation, etc.” and “Therefore, the disposition in this case is illegal because the object or content of the correction order cannot be considered to have been specified clearly enough for Mr. He said, “It did not contain any data such as drawings or photos that could be used to specify whether or not it was done,” and added, “In other words, this is nothing more than an assumption without any objective basis.” At the same time, he added, “There is no data to acknowledge that Mr. A had expanded the building without permission after acquiring ownership of the building in this case, and even considering the acquisition process, it is difficult to say that Mr. A was able to know this information.” Digital Content Team[View full article] Demolition order 20 years after purchasing the building... Law “Failure to specify the subject of correction is illegal” (Shortcut)

A real estate brokerage assistant who deceived landlords and tenants and stole tens of millions of won in deposit money was sentenced to prison. On the 25th of last month, the Seoul Eastern District Court sentenced Mr. A, an assistant brokerage indicted on charges of embezzlement and forgery of private documents, to six months in prison. Mr. A was accused of brokering a lease contract with a sale price of 200 million won in 2022 and embezzling 70 million won of deposit paid by tenant B. Mr. A was found to have continued to engage in illegal activities, such as brokering contracts, even though he was an assistant broker. According to the Licensed Real Estate Brokerage Act, an assistant broker is a person employed by a licensed real estate agent and can only perform simple auxiliary duties such as providing on-site guidance to brokerage items or general affairs. Mr. A is said to have forged a contract, delivered forged private documents to Mr. B, etc., and used most of the stolen money as personal investment funds. During the trial, Mr. A It was argued that charges such as forgery of a private document were not established because the contract was shown to the lessor and his signature and seal were obtained. The court ruled that Mr. A was guilty of forgery of a private document because he deceived the lessor into signing and sealing a document against the will of the landlord, so he was sentenced to prison. The court said, "The defendant admits to some crimes, but in light of his statements and attitude in court, does he truly reflect on and regret this incident? He also pointed out, “It’s questionable.” Attorney Park Jeong-ho of Daeryun Law Firm, who is the legal representative of victim B, emphasized, "This case is a serious economic crime in which Mr. A, who was in charge of assisting brokerage, abused his trust to embezzle customers' funds and forged and used private documents such as contracts to conceal this." Go Woori (wego@ikbc.co.kr)[View full article] Brokerage assistant who stole 7,000,000 down payment sentenced to prison...Law "Both the landlord and the tenant were deceived" (Shortcut)

Although it possesses world-class data and infrastructure, the utilization of high value-added areas is low compared to developed countries, so technological advancement and system improvement must be achieved simultaneously. 21The century economy is driven by data. In particular, healthcare data is a strategic resource that can simultaneously improve public health and drive future industrial growth.. Korea has the world’s best medical system and information technology(IT) Although we had the infrastructure, Laws and institutions cannot keep up with the pace of technological development. 'data paradox'is facing a structural limitation called.The solution is not simply deregulation. A paradigm shift is needed to redesign laws and institutions to facilitate data use.. There is a clear path to simultaneously create industrial development and social value while ensuring safety and trust.. Developed countries are already leading the way. information protection-Finding a balance between uses EU·USA European Union(EU)The Personal Information Protection Act(GDPR)While establishing a strict personal information protection system through 'EU health data space(European Health Data Space, EHDS)'through 27We are presenting an innovative model that integrates and utilizes medical data from 100 member countries.. This is an example that demonstrates that personal information protection and data utilization are not in conflict but rather are complementary to each other..The American approach is more pragmatic.. '21Century Healing Method(21st Century Cures Act)'Blocks the refusal of legitimate data sharing requests from medical institutions(Information Blocking)It is defined as a subject of legal sanctions.. Standard raw drug product(API) Patients through mandatory, researcher, We have built an ecosystem that allows companies to quickly access the data they need.. 'TEFCA(Trusted Exchange Framework and Common Agreement)'We are building a nationwide medical information exchange network through, today 10doggy 'QHIN(Qualified Health Information Network)' Under the system, clinicians, hospitals, clinics, nursing facilities, public health authorities, etc. 4only1000Forms several unique networks. Food and Drug Administration(FDA)is actual usage data(RWD)and actual use basis(RWE)We are significantly lowering the market entry barrier for innovative medical devices by utilizing. Korea Health Insurance Review and Assessment Service is overflowing with resources but unable to utilize them, National Health Insurance Corporation, The healthcare big data held by major public institutions such as the Korea Disease Control and Prevention Agency is the world's best in terms of scale and quality.. Nevertheless, new drug development, precision medicine, Utilization in high value-added areas such as digital therapeutics is still limited..The core problem is multi-layered. Data compatibility issues due to heterogeneous systems and lack of standardization between medical institutions, Decreased analysis efficiency due to fragmented data structure, And above all, school expulsions due to conservative interpretations of legal regulations are having a complex effect..'Establishment of national integrated bio big data'It appears that state-led integrated platform projects such as can become a key foundation for overcoming these structural limitations.. today 1step(77only2000people genome data collection)is in progress, Due to the delay in recruiting participants and low institutional participation, a red flag has been turned on to achieve the goal.. This is why technological advancement and institutional improvement must occur simultaneously..More specifically, the refinement of personal information de-identification and pseudonymization technology., Electronic medical record(EMR)·Compliance with international standards for medical imaging and genomic data, Safe opening and expansion of the scope of use of cutting-edge omics data such as spatial transcriptome and single cell transcriptome must be done in parallel..Consistency of laws and guidelines is also an urgent task.. Current Personal Information Protection Act28condolences8In principle, overseas transfer of personal information is prohibited., Safety measures and procedural requirements are strictly required when exceptions are applied.. In particular, detailed standards for overseas transfer and combination of pseudonym information are still being refined, so there is uncertainty in practice.. It is time to rationally improve data transfer requirements and procedures for global research cooperation and industrial development, assuming appropriate safety measures.. Ministry of Food and Drug Safety 'AI Medical device regulatory innovation'What we can learn from this: The answer is already within us.. Ministry of Food and Drug Safety’s artificial intelligence(AI) Innovation in medical device regulation is proof of this.. The world's first creation AI Establish medical device approval and review guidelines, Pharmaceutical Manufacturing and Quality Control Standards(GMP) and the results of allowing rapid market entry subject to meeting minimum performance requirements are surprising.. AI Number of medical device approvals based on 2022year 47last year in 108By the matter 3After years 2It has more than doubled. It is assessed that Korea has emerged as a leader in global digital healthcare regulatory innovation, both in name and reality..This success was possible 'allowed after ban'not this 'Promote utilization by adhering to principles' It was thanks to the adoption of the method. Establish clear safety and quality standards, If this is met, the system has been designed to enable rapid use without excessive procedural burden.. 'positive→negative'There is a need to spread a pragmatic approach across data policies.. The key is as follows.first, Clear regulations on safety and standardization requirements. Ambiguous standards lead to excessively conservative interpretations., This leads to a delay in innovation.. second, It is procedural efficiency that ensures rapid utilization when requirements are met.. The complex and lengthy approval process is itself a barrier to entry..third, existing 'positive method'Rather than simply expanding the scope of exceptions allowed,, It adheres to basic principles such as safety and personal information protection, but promotes use. 'negative method'A fundamental shift is needed to. In an era where law becomes a partner in innovation, healthcare data can simultaneously realize the social value of industrial development and guaranteeing the people's right to health. 21It is a key asset of the century. If you just stop at accumulating, This precious resource is only going to waste..Safety and innovation are not zero-sum games. Ministry of Food and Drug Safety AI Cases of medical device regulatory innovation clearly prove this.. With appropriate institutional design, the two values ​​can be mutually reinforcing..When the law functions as a partner rather than an obstacle to innovation, Both values ​​of industrial innovation and public convenience can be realized.. The golden time for change is now.. [View full article] Korea has accumulated a gold mine of healthcare data and cannot use it... A paradigm shift is needed [Daeryun’s Biz law forum] (Shortcut)