Checklist for Facilitators of Medical Assistance in India
If NGOs or companies are acting as mere facilitators for medical assistance—meaning they coordinate or support medical services without directly providing them—their compliance requirements will differ. However, they still need to adhere to several key regulations to ensure legal and operational security. Here’s a modified compliance checklist tailored to facilitators:
Compliance Checklist for Facilitators of Medical Assistance in India
1. Legal Entity and Registration
- Societies Registration Act, 1860 / Indian Trusts Act, 1882 / Companies Act, 2013: Ensure your organization is registered under the appropriate legal framework (Society, Trust, Section 8 Company).
- Foreign Contribution Regulation Act (FCRA), 2010: If receiving foreign funds, register under FCRA and comply with reporting requirements.
2. Funding and Financial Compliance
- Income Tax Act, 1961: Obtain relevant exemptions like 12A and 80G, if eligible, for tax benefits.
- Goods and Services Tax (GST): Register for GST, if applicable, and ensure correct filing of returns for any services provided.
3. Partnership and Contractual Compliance
- Indian Contract Act, 1872: Review all contracts, Memoranda of Understanding (MoUs), and agreements with healthcare providers, donors, and other stakeholders to ensure legal validity and protection.
- Service Level Agreements (SLAs): Define roles and responsibilities clearly in agreements to avoid liability.
4. Data Privacy and Information Security
- Information Technology Act, 2000, and IT Rules, 2011 (amended 2021): Ensure proper data security protocols for handling sensitive information, even if only as a facilitator.
- Confidentiality Agreements: Use Non-Disclosure Agreements (NDAs) with all parties involved to protect patient and operational data.
5. Coordination with Medical Providers
- Due Diligence: Conduct due diligence on medical providers to ensure they are licensed and compliant with healthcare regulations.
- Compliance with Clinical Establishments Act, 2010: Ensure partnered establishments meet national or state-level medical standards.
6. Governance and Accountability
- Board and Committee Governance: Maintain a functioning board or governing body to oversee operations, including ethical practices and regulatory compliance.
- Audit and Financial Controls: Implement internal financial controls and undergo periodic audits to ensure transparency.
7. Insurance and Indemnity
- Professional Indemnity Insurance: Secure insurance to protect against claims arising from facilitation errors or advice.
- Employee Insurance: Ensure coverage for employees and volunteers engaged in field activities.
8. Volunteer and Employee Compliance
- Volunteers Protection Act: Ensure volunteers have proper documentation, identification, and clear guidelines on their roles and responsibilities.
- Labor Laws: Adhere to relevant labor laws for any paid staff, including wage laws, social security, and workplace safety regulations.
9. Reporting and Transparency
- Maintain Accurate Records: Document all facilitation activities, including services coordinated, funds received and disbursed, and interactions with medical professionals or entities.
- Regular Reporting to Authorities: Comply with mandatory reporting requirements under laws applicable to your entity type (Society, Trust, Section 8 Company).
10. Ethical Standards and Community Engagement
- Adhere to Ethical Guidelines: Follow ethical standards for interacting with patients, communities, and medical providers.
- Community Involvement: Engage with local communities to ensure services are culturally sensitive and appropriate.
11. Marketing and Communication Compliance
- Compliance with Advertising Standards: Ensure that any promotion or communication about the services facilitated does not violate advertising guidelines or make false claims.
- Transparency in Communications: Clearly communicate the scope of services offered and the role as a facilitator, not a direct service provider.
12. Risk Management
- Identify and Mitigate Risks: Conduct risk assessments related to partnerships, data handling, and financial management.
- Crisis Management Plan: Develop a plan for managing incidents such as service failures, data breaches, or disputes.
13. Local Laws and Regulations
- State-specific Health and Safety Laws: Ensure that activities conform to local regulations regarding health and safety.
- Municipal and Panchayat Requirements: Obtain necessary local permissions or clearances, particularly for field operations.
14. Monitoring and Evaluation
- Impact Assessment: Regularly assess the impact of your facilitation activities on target communities and beneficiaries.
- Continuous Improvement: Use feedback and evaluations to improve processes and ensure compliance standards are met.
15. Digital and Online Presence
- Website and Social Media Compliance: Ensure that digital communication complies with national laws on privacy, consumer protection, and content regulations.
Additional Considerations:
- Stay updated on new regulations or amendments, especially those related to healthcare, NGOs, and data protection.
- Develop a compliance manual or guide specific to your role as a facilitator to ensure that all staff and volunteers understand their obligations.
16. Human Rights and Ethical Standards
- Compliance with Human Rights Norms: Ensure all facilitation activities respect human rights, particularly in sensitive contexts such as providing assistance to marginalized groups.
- Ethical Guidelines for Research or Data Collection: If conducting surveys or research as part of your facilitation role, obtain necessary ethical approvals and ensure compliance with research ethics.
17. Emergency and Disaster Management
- Compliance with Disaster Management Act, 2005: Be prepared for emergencies by aligning with national disaster management protocols if facilitating medical aid in disaster-prone areas.
- Emergency Response Protocols: Develop and maintain protocols for emergency response, including evacuation plans, coordination with local authorities, and communication strategies.
18. Environmental Compliance
- Environmental Regulations: Ensure compliance with relevant environmental laws, particularly if involved in activities that may impact the local environment (e.g., waste disposal, water usage in medical camps).
- Sustainable Practices: Adopt sustainable practices in your facilitation activities, such as minimizing waste and using eco-friendly materials.
19. Cross-Border Regulations
- Regulations on Cross-Border Activities: If your facilitation involves cross-border medical supplies or coordination, ensure compliance with export/import regulations, customs laws, and international agreements.
- Coordination with Foreign Entities: Be aware of international laws and bilateral agreements that may affect partnerships with foreign medical entities or donors.
20. Adherence to International Standards
- Compliance with International Health Regulations (IHR, 2005): Align with international health standards and regulations, especially if your facilitation activities have cross-border implications or involve international stakeholders.
- Adherence to WHO Guidelines: Follow World Health Organization (WHO) guidelines for any health-related activities, particularly in emergencies or public health initiatives.
21. Local Community Engagement
- Community Consent and Buy-In: Ensure informed consent from local communities for any medical assistance or health programs you facilitate.
- Engagement with Local Health Workers: Collaborate with local health workers to ensure culturally appropriate and effective facilitation.
22. Compliance with Health and Safety at Events
- Permissions for Public Gatherings: Obtain necessary permissions for organizing health camps, workshops, or public gatherings as part of your facilitation activities.
- Safety Protocols for Events: Develop safety protocols, including first aid, emergency evacuation plans, and COVID-19 safety measures.
23. Transparency with Beneficiaries
- Clear Communication of Roles: Transparently communicate your organization’s role as a facilitator, not a direct provider, to all stakeholders, including beneficiaries.
- Disclosure of Fund Utilization: If funds are collected from the public or donors for specific facilitation activities, provide regular disclosures on fund utilization.
24. Compliance with Technology Laws
- Telemedicine Regulations: If facilitating telemedicine services, ensure compliance with the Ministry of Health and Family Welfare’s Telemedicine Practice Guidelines (2020).
- Electronic Health Records (EHR) Standards: Follow national standards for managing and transferring electronic health records securely.
25. Awareness and Training Programs
- Regular Compliance Training: Conduct training sessions for all staff and volunteers on relevant laws, regulations, and internal policies.
- Awareness Programs for Stakeholders: Organize awareness programs for partners, local communities, and medical professionals about legal obligations and ethical practices.
26. Cybersecurity Measures
- Data Breach Protocols: Develop and implement a response plan for potential data breaches, ensuring compliance with data protection laws.
- Cybersecurity Standards: Maintain cybersecurity protocols to protect sensitive information, particularly when facilitating digital health initiatives.
27. Intellectual Property Rights (IPR) Compliance
- Compliance with Copyright and Trademark Laws: Ensure that all educational materials, software, and resources used or developed during facilitation activities respect intellectual property rights.
- Protection of Proprietary Information: Secure any proprietary tools or methods your organization develops to support facilitation activities.
28. Anti-Corruption and Anti-Bribery Compliance
- Adherence to Prevention of Corruption Act, 1988: Ensure that all facilitation activities comply with anti-corruption laws.
- Anti-Bribery Policies: Develop and enforce strict anti-bribery policies for all employees, partners, and volunteers.
29. Conflict of Interest Policies
- Conflict of Interest Declarations: Require all staff and board members to disclose any potential conflicts of interest, particularly when partnering with medical entities or receiving funds.
- Policy for Managing Conflicts: Develop a policy to manage conflicts of interest transparently and ethically.
30. Use of Drones and Emerging Technologies
- Drone Regulations: If using drones for medical supply delivery or surveillance, comply with the Ministry of Civil Aviation’s Drone Rules, 2021.
- Ethical Use of AI and Emerging Technologies: Ensure the ethical use of AI or other technologies, particularly when handling sensitive health data.
31. Child Protection Compliance
- Compliance with Juvenile Justice (Care and Protection of Children) Act, 2015: Ensure that any activities involving children adhere to child protection laws.
- Child Protection Policies: Implement child protection policies, particularly for health camps or awareness programs involving children.
Conclusion:
Even as facilitators, NGOs and companies have several critical compliance obligations to manage. By adhering to these guidelines, they can avoid legal risks, protect their reputation, and ensure their activities align with both national and international standards. It’s essential to regularly review and update this checklist to reflect changes in laws and regulations.
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