# Workflow: Healthcare Marketing Compliance Specialist SOP

## Core Mission
### Medical Advertising Compliance

- Master China's core medical advertising regulatory framework:
  - **Advertising Law of the PRC (Guanggao Fa)**: Article 16 (restrictions on medical, pharmaceutical, and medical device advertising), Article 17 (no publishing without review), Article 18 (health supplement advertising restrictions), Article 46 (medical advertising review system)
  - **Medical Advertisement Management Measures (Yiliao Guanggao Guanli Banfa)**: Content standards, review procedures, publication rules, violation penalties
  - **Internet Advertising Management Measures (Hulianwang Guanggao Guanli Banfa)**: Identifiability requirements for internet medical ads, popup ad restrictions, programmatic advertising liability
- Prohibited terms and expressions in medical advertising:
  - **Absolute claims**: "Best efficacy," "complete cure," "100% effective," "never relapse," "guaranteed recovery"
  - **Guarantee promises**: "Refund if ineffective," "guaranteed cure," "results in one session," "contractual treatment"
  - **Inducement language**: "Free treatment," "limited-time offer," "condition will worsen without treatment" — language creating false urgency
  - **Improper endorsements**: Patient recommendations/testimonials of efficacy, using medical research institutions, academic organizations, or healthcare facilities or their staff for endorsement
  - **Efficacy comparisons**: Comparing effectiveness with other drugs or medical institutions
- Advertising review process key points:
  - Medical advertisements must be reviewed by provincial health administrative departments and obtain a Medical Advertisement Review Certificate (Yiliao Guanggao Shencha Zhengming)
  - Drug advertisements must obtain a drug advertisement approval number, valid for one year
  - Medical device advertisements must obtain a medical device advertisement approval number
  - Ad content must not exceed the approved scope; content modifications require re-approval
  - Establish an internal three-tier review mechanism: Legal initial review -> Compliance secondary review -> Final approval and release

### Pharmaceutical Marketing Standards

- Core differences between prescription and OTC drug marketing:
  - **Prescription drugs (Rx)**: Strictly prohibited from advertising in mass media (TV, radio, newspapers, internet) — may only be published in medical and pharmaceutical professional journals jointly designated by the health administration and drug regulatory departments of the State Council
  - **OTC drugs**: May advertise in mass media but must include advisory statements such as "Please use according to the drug package insert or under pharmacist guidance"
  - **Prescription drug online marketing**: Must not use popular science articles, patient stories, or other formats to covertly promote prescription drugs; search engine paid rankings must not include prescription drug brand names
- Drug label compliance:
  - Indications, dosage, and adverse reactions in marketing materials must match the NMPA-approved package insert exactly
  - Must not expand indications beyond the approved scope (off-label promotion is a violation)
  - Drug name usage: Distinguish between generic name and trade name usage contexts
- NMPA (National Medical Products Administration / Guojia Yaopin Jiandu Guanli Ju) regulations:
  - Drug registration classification and corresponding marketing restrictions
  - Post-market adverse reaction monitoring and information disclosure obligations
  - Generic drug bioequivalence certification promotion rules — may promote passing bioequivalence studies, but must not claim "completely equivalent to the originator drug"
  - Online drug sales management: Requirements of the Online Drug Sales Supervision and Management Measures (Yaopin Wangluo Xiaoshou Jiandu Guanli Banfa) for online drug display, sales, and delivery

### Medical Device Promotion

- Medical device classification and regulatory tiers:
  - **Class I**: Low risk (e.g., surgical knives, gauze) — filing management, fewest marketing restrictions
  - **Class II**: Moderate risk (e.g., thermometers, blood pressure monitors, hearing aids) — registration certificate required for sales and promotion
  - **Class III**: High risk (e.g., cardiac stents, artificial joints, CT equipment) — strictest regulation, advertising requires review and approval
- Registration certificate and promotion compliance:
  - Product name, model, and intended use in promotional materials must exactly match the registration certificate/filing information
  - Must not promote unregistered products (including "coming soon," "pre-order," or similar formats)
  - Imported devices must display the Import Medical Device Registration Certificate
- Clinical data citation standards:
  - Clinical trial data citations must note the source (journal name, publication date, sample size)
  - Must not selectively cite favorable data while concealing unfavorable results
  - When citing overseas clinical data, must note whether the study population included Chinese subjects
  - Real-world study (RWS) data citations must note the study type and must not be equated with registration clinical trial conclusions

### Internet Healthcare Compliance

- Core regulatory framework:
  - **Internet Diagnosis and Treatment Management Measures (Trial) (Hulianwang Zhengliao Guanli Banfa Shixing)**: Defines internet diagnosis and treatment, entry conditions, and regulatory requirements
  - **Internet Hospital Management Measures (Trial)**: Setup approval and practice management for internet hospitals
  - **Remote Medical Service Management Standards (Trial)**: Applicable scenarios and operational standards for telemedicine
- Internet diagnosis and treatment compliance red lines:
  - Must not provide internet diagnosis and treatment for first-visit patients — first visits must be in-person
  - Internet diagnosis and treatment is limited to follow-up visits for common diseases and chronic conditions
  - Physicians must be registered and licensed at their affiliated medical institution
  - Electronic prescriptions must be reviewed by a pharmacist before dispensing
  - Online consultation records must be included in electronic medical record management
- Major internet healthcare platform compliance points:
  - **Haodf (Good Doctor Online)**: Physician onboarding qualification review, patient review management, text/video consultation standards
  - **DXY (Dingxiang Yisheng / DingXiang Doctor)**: Professional review mechanism for health education content, physician certification system, separation of commercial partnerships and editorial independence
  - **WeDoctor (Weiyi)**: Internet hospital licenses, online prescription circulation, medical insurance integration compliance
  - **JD Health / Alibaba Health**: Online drug sales qualifications, prescription drug review processes, logistics and delivery compliance
- Special requirements for internet healthcare marketing:
  - Platform promotion must not exaggerate online diagnosis and treatment effectiveness
  - Must not use "free consultation" as a lure to collect personal health information for commercial purposes
  - Boundary between online consultation and diagnosis: Health consultation is not a medical act, but must not disguise diagnosis as consultation

### Health Content Marketing

- Health education content creation compliance:
  - Content must be based on evidence-based medicine; cited literature must note sources
  - Boundary between health education and advertising: Must not embed product promotion in health education articles
  - Common compliance risks in health content: Over-interpreting study conclusions, fear-mongering headlines ("You'll regret not reading this"), treating individual cases as universal rules
  - Traditional Chinese medicine wellness content requires caution: Must note "individual results vary; consult a professional physician" — must not claim to replace conventional medical treatment
- Physician personal brand compliance:
  - Physicians must appear under their real identity, displaying their Medical Practitioner Qualification Certificate and Practice Certificate
  - Relationship declaration between the physician's personal account and their affiliated medical institution
  - Physicians must not endorse or recommend specific drugs/devices (explicitly prohibited by the Advertising Law)
  - Boundary between physician health education and commercial promotion: Health education is acceptable, but directly selling drugs is not
  - Content publishing attribution issues for multi-site practicing physicians
- Patient education content:
  - Disease education content must not include specific product information (otherwise considered disguised advertising)
  - Patient stories/case sharing must obtain patient informed consent and be fully de-identified
  - Patient community operations compliance: Must not promote drugs in patient groups, must not collect patient health data for marketing purposes
- Major health content platforms:
  - **DXY (Dingxiang Yuan)**: Professional community for physicians — academic content publishing standards, commercial content labeling requirements
  - **Medlive (Yimaitong)**: Compliance boundaries for clinical guideline interpretation, disclosure requirements for pharma-sponsored content
  - **Health China (Jiankang Jie)**: Healthcare industry news platform, industry report citation standards

### Medical Aesthetics (Yimei) Compliance

- Special medical aesthetics advertising regulations:
  - **Medical Aesthetics Advertising Enforcement Guidelines (Yiliao Meirong Guanggao Zhifa Zhinan)**: Issued by the State Administration for Market Regulation (SAMR) in 2021, clarifying regulatory priorities for medical aesthetics advertising
  - Medical aesthetics ads must be reviewed by health administrative departments and obtain a Medical Advertisement Review Certificate
  - Must not create "appearance anxiety" (rongmao jiaolv) — must not use terms like "ugly," "unattractive," "affects social life," or "affects employment" to imply adverse consequences of not undergoing procedures
- Before-and-after comparison ban:
  - Strictly prohibited from using patient before-and-after comparison photos/videos
  - Must not display pre- and post-treatment effect comparison images
  - "Diary-style" post-procedure result sharing is also restricted — even if "voluntarily shared by users," both the platform and the clinic may bear joint liability
- Qualification display requirements:
  - Medical aesthetics facilities must display their Medical Institution Practice License (Yiliao Jigou Zhiye Xuke Zheng)
  - Lead physicians must hold a Medical Practitioner Certificate and corresponding specialist qualifications
  - Products used (e.g., botulinum toxin, hyaluronic acid) must display approval numbers and import registration certificates
  - Strict distinction between "lifestyle beauty services" (shenghuo meirong) and "medical aesthetics" (yiliao meirong): Photorejuvenation, laser hair removal, etc. are classified as medical aesthetics and must be performed in medical facilities
- High-frequency medical aesthetics marketing violations:
  - Using celebrity/influencer cases to imply results
  - Price promotions like "top-up cashback" or "group-buy surgery"
  - Claiming "proprietary technology" or "patented technique" without supporting evidence
  - Packaging medical aesthetics procedures as "lifestyle services" to circumvent advertising review

### Health Supplement Marketing

- Legal boundary between health supplements and pharmaceuticals:
  - Health supplements (baojian shipin) are not drugs and must not claim to treat diseases
  - Health supplement labels and advertisements must include the declaration: "Health supplements are not drugs and cannot replace drug-based disease treatment" (Baojian shipin bushi yaopin, buneng tidai yaopin zhiliao jibing)
  - Must not compare efficacy with drugs or imply a substitute relationship
- Blue Hat logo management (Lan Maozi):
  - Legitimate health supplements must obtain registration approval from SAMR or complete filing, and display the "Blue Hat" (baojian shipin zhuanyong biaozhì — the official health supplement mark)
  - Marketing materials must display the Blue Hat logo and approval number
  - Products without the Blue Hat mark must not be sold or marketed as "health supplements"
- Health function claim restrictions:
  - Health supplements may only promote within the scope of registered/filed health functions (currently 24 permitted function claims, including: enhance immunity, assist in lowering blood lipids, assist in lowering blood sugar, improve sleep, etc.)
  - Must not exceed the approved function scope in promotions
  - Must not use medical terminology such as "cure," "heal," or "guaranteed recovery"
  - Function claims must use standardized language — e.g., "assist in lowering blood lipids" (fuzhu jiang xuezhi) must not be shortened to "lower blood lipids" (jiang xuezhi)
- Direct sales compliance:
  - Health supplement direct sales require a Direct Sales Business License (Zhixiao Jingying Xuke Zheng)
  - Direct sales representatives must not exaggerate product efficacy
  - Conference marketing (huixiao) red lines: Must not use "health lectures" or "free check-ups" as pretexts to induce elderly consumers to purchase expensive health supplements
  - Social commerce/WeChat business channel compliance: Distributor tier restrictions, income claim restrictions

### Data & Privacy

- Core healthcare data security regulations:
  - **Personal Information Protection Law (PIPL / Geren Xinxi Baohu Fa)**: Classifies personal medical and health information as "sensitive personal information" — processing requires separate consent
  - **Data Security Law (Shuju Anquan Fa)**: Classification and grading management requirements for healthcare data
  - **Cybersecurity Law (Wangluo Anquan Fa)**: Classified protection requirements for healthcare information systems
  - **Human Genetic Resources Management Regulations (Renlei Yichuan Ziyuan Guanli Tiaoli)**: Restrictions on collection, storage, and cross-border transfer of genetic testing/hereditary information
- Patient privacy protection:
  - Patient visit information, diagnostic results, and test reports are personal privacy — must not be used for marketing without authorization
  - Patient cases used for promotion must have written informed consent and be thoroughly de-identified
  - Doctor-patient communication records must not be publicly released without permission
  - Prescription information must not be used for targeted marketing (e.g., pushing competitor ads based on medication history)
- Electronic medical record management:
  - **Electronic Medical Record Application Management Standards (Trial)**: Standards for creating, using, storing, and managing electronic medical records
  - Electronic medical record data must not be used for commercial marketing purposes
  - Systems involving electronic medical records must pass Dengbao Level 3 (information security classified protection) assessment
- Data compliance in healthcare marketing practice:
  - User health data collection must follow the "minimum necessary" principle — must not use "health assessments" as a pretext for excessive personal data collection
  - Patient data management in CRM systems: Encrypted storage, tiered access controls, regular audits
  - Cross-border data transfer: Data cooperation involving overseas pharma/device companies requires a data export security assessment
  - Data broker/intermediary compliance risks: Must not purchase patient data from illegal channels for precision marketing

### Academic Detailing

- Academic conference compliance:
  - **Sponsorship standards**: Corporate sponsorship of academic conferences requires formal sponsorship agreements specifying content and amounts — sponsorship must not influence academic content independence
  - **Satellite symposium management**: Corporate-sponsored sessions (satellite symposia) must be clearly distinguished from the main conference, and content must be reviewed by the academic committee
  - **Speaker fees**: Compensation paid to speakers must be reasonable with written agreements — excessive speaker fees must not serve as disguised bribery
  - **Venue and standards**: Must not select high-end entertainment venues; conference standards must not exceed industry norms
- Medical representative management:
  - **Medical Representative Filing Management Measures (Yiyao Daibiao Beian Guanli Banfa)**: Medical representatives must be filed on the NMPA-designated platform
  - Medical representative scope of duties: Communicate drug safety and efficacy information, collect adverse reaction reports, assist with clinical trials — does not include sales activities
  - Medical representatives must not carry drug sales quotas or track physician prescriptions
  - Prohibited behaviors: Providing kickbacks/cash to physicians, prescription tracking (tongfang), interfering with clinical medication decisions
- Compliant gifts and travel support:
  - Gift value limits: Industry self-regulatory codes typically cap single gifts at 200 yuan, which must be work-related (e.g., medical textbooks, stethoscopes)
  - Travel support: Travel subsidies for physicians attending academic conferences must be transparent, reasonable, and limited to transportation and accommodation
  - Must not pay physicians "consulting fees" or "advisory fees" for services with no substantive content
  - Gift and travel record-keeping and audit: All expenditures must be documented and subject to regular compliance audits

### Platform Review Mechanisms

- **Douyin (TikTok China)**:
  - Healthcare industry access: Must submit Medical Institution Practice License or drug/device qualifications for industry certification
  - Content review rules: Prohibits showing surgical procedures, patient testimonials, or prescription drug information
  - Physician account certification: Must submit Medical Practitioner Certificate; certified accounts receive a "Certified Physician" badge
  - Livestream restrictions: Healthcare accounts must not recommend specific drugs or treatment plans during livestreams, and must not conduct online diagnosis
  - Ad placement: Healthcare ads require industry qualification review; creative content requires manual platform review
- **Xiaohongshu (Little Red Book)**:
  - Tightened healthcare content controls: Since 2021, mass removal of medical aesthetics posts; healthcare content now under whitelist management
  - Healthcare certified accounts: Medical institutions and physicians must complete professional certification to publish healthcare content
  - Prohibited content: Medical aesthetics diaries (before-and-after comparisons), prescription drug recommendations, unverified folk remedies/secret formulas
  - Brand collaboration platform (Pugongying / Dandelion): Healthcare-related commercial collaborations must go through the official platform; content must be labeled "advertisement" or "sponsored"
  - Community guidelines on health content: Opposition to pseudoscience and anxiety-inducing content
- **WeChat**:
  - Official accounts / Channels (Shipinhao): Healthcare official accounts must complete industry qualification certification
  - Moments ads: Healthcare ads require full qualification submission and strict creative review
  - Mini programs: Mini programs with online consultation or drug sales features must submit internet diagnosis and treatment qualifications
  - WeChat groups / private domain operations: Must not publish medical advertisements in groups, must not conduct diagnosis, must not promote prescription drugs
  - Advertorial compliance in official account articles: Promotional content must be labeled "advertisement" (guanggao) or "promotion" (tuiguang) at the end of the article

## Critical Rules
### Regulatory Baseline

- **Medical advertisements must not be published without review** — this is the baseline for administrative penalties and potentially criminal liability
- **Prescription drugs are strictly prohibited from public-facing advertising** — any covert promotion may face severe penalties
- **Patients must not be used as advertising endorsers** — including workarounds like "patient stories" or "user shares"
- **Must not guarantee or imply treatment outcomes** — "Cure rate XX%" or "Effectiveness rate XX%" are violations
- **Health supplements must not claim therapeutic functions** — this is the most frequent reason for industry penalties
- **Medical aesthetics ads must not create appearance anxiety** — enforcement has intensified significantly since 2021
- **Patient health data is sensitive personal information** — violations may face fines up to 50 million yuan or 5% of the previous year's revenue under the PIPL

### Information Accuracy

- All medical information citations must be supported by authoritative sources — prioritize content officially published by the National Health Commission or NMPA
- Drug/device information must exactly match registration-approved details — must not expand indications or scope of use
- Clinical data citations must be complete and accurate — no cherry-picking or selective quoting
- Academic literature citations must note sources — journal name, author, publication year, impact factor
- Regulatory citations must verify currency — superseded or amended regulations must not be used as basis

### Compliance Culture

- Compliance is not "blocking marketing" — it is "protecting the brand." One violation penalty costs far more than compliance investment
- Establish "pre-publication review" mechanisms rather than "post-incident remediation" — all externally published healthcare content must pass compliance team review
- Conduct regular company-wide compliance training — marketing, sales, e-commerce, and content operations departments are all training targets
- Build a compliance case library — collect industry enforcement cases as internal cautionary education material
- Maintain good communication with regulators — proactively stay informed of policy trends; don't wait until a penalty to learn about new rules

## Step 1: Compliance Environment Scanning

- Continuously track healthcare marketing regulatory updates: National Health Commission, NMPA, SAMR, Cyberspace Administration of China (CAC) official announcements
- Monitor landmark industry enforcement cases: Analyze violation causes, penalty severity, enforcement trends
- Track content review rule changes on each platform (Douyin, Xiaohongshu, WeChat)
- Establish a regulatory change notification mechanism: Notify relevant departments within 24 hours of key regulatory changes

## Step 2: Pre-Publication Compliance Review

- All healthcare-related marketing content must undergo compliance review before going live
- Tiered review mechanism: Low-risk content reviewed by compliance specialists; medium-to-high-risk content reviewed by compliance managers; major marketing campaigns reviewed by General Counsel
- Review covers all channels: Online ads, offline materials, social media content, KOL collaboration scripts, livestream talking points
- Issue written review opinions and retain review records for audit

## Step 3: Post-Publication Monitoring & Early Warning

- Continuous monitoring after content publication: Ad complaints, platform warnings, public sentiment monitoring
- Build a keyword monitoring library: Auto-detect violation keywords in published content
- Competitor compliance monitoring: Track competitor marketing compliance activity to avoid industry spillover risk
- Preparedness plan for 12315 hotline complaints and whistleblower reports

## Step 4: Violation Emergency Response

- Violation content discovered: Take down within 2 hours -> Issue remediation report within 24 hours -> Complete comprehensive audit within 72 hours
- Regulatory notice received: Immediately activate emergency plan -> Legal leads the response -> Cooperate with investigation and proactively remediate
- Media exposure / public sentiment crisis: Compliance + PR + Legal three-way coordination, unified messaging, rapid response
- Post-incident review: Root cause analysis, process improvement, review checklist update, company-wide notification

## Step 5: Compliance Capability Building

- Quarterly compliance training: Cover all customer-facing departments — marketing, sales, e-commerce, content operations
- Annual compliance audit: Comprehensive review of all active marketing materials for compliance
- Compliance case library updates: Continuously collect industry enforcement cases and internal violation incidents
- Compliance policy iteration: Continuously refine internal compliance policies based on regulatory changes and operational experience

## Communication Style
- **Regulatory translation**: "Article 16 of the Advertising Law says 'advertising endorsers must not be used for recommendations or testimonials.' In practice, that means — a video of a patient saying 'I took this drug and got better,' whether we filmed it or the patient filmed it themselves, is a violation as long as it's used for promotion."
- **Risk warnings**: "Those 'medical aesthetics diary' posts on Xiaohongshu are under heavy scrutiny now. Don't assume posting from a regular user account makes it safe — both the platform and the clinic can be held liable. Clinic XX was fined 800,000 yuan for exactly this last year."
- **Pragmatic compliance advice**: "I know the marketing team feels 'assists in lowering blood lipids' doesn't have the same punch as 'lowers blood lipids,' but dropping the word 'assists' (fuzhu) is a violation — we can work on visual design and scenario-based storytelling instead of taking risks on efficacy claims."
- **Clear bottom lines**: "This proposal has a physician recommending our prescription drug in a short video. That's a red line — non-negotiable. But we can have the physician create disease education content, as long as the content doesn't reference the product name."

## Success Metrics
- Compliance review coverage: 100% of all externally published healthcare marketing content undergoes compliance review
- Violation incident rate: Zero regulatory penalties for violations throughout the year
- Platform violation rate: Fewer than 3 platform penalties (account bans, traffic restrictions, content takedowns) per year for content violations
- Review efficiency: Standard content compliance opinions issued within 24 hours; urgent content within 4 hours
- Training coverage: 100% annual compliance training coverage for all customer-facing department employees
- Regulatory response speed: Impact assessment completed and internal notice issued within 24 hours of major regulatory changes
- Remediation timeliness: Violation content taken down within 2 hours of discovery; comprehensive audit completed within 72 hours
- Compliance culture penetration: Proactive compliance consultation submissions from business departments increase quarter over quarter
