数字医疗2025：权威的全球法律指南，提供顶级律师的比较分析

CHINA2CHAMBERS.COMLaw and PracticeContributed by:Alan Zhou, Charlene Huang, Jenny Chen and Stephanie WangGlobal Law OfficeContents1. Digital Healthcare Usage1.1Types of Digital Healthcare p.51.2Use/Application of Digital Healthcare p.51.3BenefitsofDigitalHealthcarep.62. Legal Frameworkp.62.1DefinitionofDigitalHealthcarep.62.2LawsandRegulationsp.62.3Role of Policymakers p.72.4Technical Standards p.92.5Issue-SpecificLegalFrameworkp.92.6SufficiencyofLegislativeFrameworkp.93. Regulatory Oversight3.1OversightofDigitalHealthcarep.93.2Non-Healthcare Regulatory Bodies p.103.3Enforcement p.113.4SufficiencyofOversightp.114. Liabilityp.114.1Legal Risks of Digital Healthcare p.114.2LiabilityFrameworksp.124.3Defences p.135. Emerging Legal Issues and Reform5.1Emerging Legal Issues in Digital Healthcare p.135.2Recent or Imminent Reform p.15 p.5p.9 p.13 CHINALaw and PracticeContributed by:Alan Zhou, Charlene Huang, Jenny Chen and Stephanie Wang,Global Law Office3CHAMBERS.COMGlobal Law Officewas one of the first law firmsin the People’s Republic of China (PRC) to havemore than 600 lawyers practising in its Beijing,Shanghai, Shenzhen and Chengdu offices. Itslife sciences and healthcare (L&H) group, alsoknown as China Life Sciences and HealthcareLaw(CLHL),is one of the leading practicegroups in China. It provides “one-stop” legalservices for every sector in the L&H industry,including R&D, clinical research organisations,pharmaceuticals,biotechnology,medical de-vices, supply producers and distributors, hos-pitals and other healthcare providers as wellAuthorsAlan Zhouis the leading partnerin the life sciences andhealthcare practice group atGlobal Law Office. He has astrong background in the area,routinely representingmultinational corporations, well-knownChinese state-owned and private enterprisesand private equity/venture capital funds. As aparticipant or an external counsel, he has beenengaged by local authorities and industrialassociations to advise on legislation andindustrial standards in the life sciences andhealthcare industry, including guidelines oncompliance and risk control, e-healthcare,medical insurance reform and medicalrepresentative administration. His insights havebeen widely published at home and abroad. as investment funds. The firm regularly advisesclients on challenging L&H legal issues suchas regulatory compliance, structuring transac-tions and contractual arrangements, realisationof pipeline and geographic expansions, capitalraising and project financing, M&A, reorganisa-tions as well as IP protection, licensing and dis-tribution arrangements, settlement of disputesinvolving adverse effects in clinical trials andmedical treatment. The firm has close links toindustrial associations and makes recommen-dations on industry codes of conduct and com-pliance management standards.Charlene Huangis a partnerand is based in Global LawOffice’s Shanghai office. Shehas in-depth experience in M&Aand cross-border licence deals,especially in the healthcare andlife sciences sector. She has led projectsinvolving outbound and inbound investment,acquisition of state-owned and private equity/assets, pipeline consolidation or restructuringof multinational corporations and variouslicence or collaboration deals in thepharmaceutical, medical device and medicalservices sectors. She regularly providessupport and advice on projects concerning celltherapy, gene therapy, digital healthcare,medical AI, etc. She also has in-depthexperience in advising multinational companiesin general corporate, cybersecurity and datamanagement matters. CHINALaw and PracticeContributed by:Alan Zhou, Charlene Huang, Jenny Chen and Stephanie Wang,Global Law Office4CHAMBERS.COMJenny Chenis a partner and isbased in Global Law Office’sShanghai office. She is anattorney-at-law in the PRC andCalifornia in the US. She is alsoa certified fraud examiner at theUS ACFE and is a certified (but non-practising)public accountant. She focuses her practice oncompliance, government investigation, internalinvestigation and data security. She is well-versed in conducting investigations inconnection with anti-corruption under the USFCPA and the UK Bribery Act as well asfinancial frauds, occupational embezzlement,self-dealing and trade secrets. She hasextensive experience in cybersecurity and datacompliance. She has handled multiple large-scale projects in e-discovery, cross-borderdata protection and security and sensitiveinformation review.Global Law Office35th & 36th FloorShanghai One ICCNo.999 Middle Huai Hai RoadXuhui DistrictShanghai 200031ChinaTel: +86 212 310 8200Fax: +86 212 310 8299Email: Alanzhou@glo.com.cnWeb: www.glo.com.cn Stephanie Wangis an ofcounsel and is based in GlobalLaw Office’s Shanghai office.She has been actively involvedin advising multinationalpharmaceutical and medtechcompanies on their corporate governance,daily operations and compliance. She hasextensive knowledge of, and experience, in thelife sciences and healthcare industry androutinely ad