The Regulatory Compliances

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The regulatory compliances/rules required by e-health aggregators:

1. Registration under the Ministry of Corporate Affairs. The registration process


involves incorporating the business under the Companies Act, 2013 for Indian
companies (Section 3(1), The Companies Act 2013.)
2. Compulsory registration under the Central Goods & Service Tax Act, 2017 [Section
24(ix), (x) and (xi), The Central Goods and Service Tax, 2017.]
3. Consumer Protection Act 2019- Section 2(47), Section 2(6)(viii), Section 6 and 8,
Section 2(9)(ii)
4. Competition Act, 2002- Section 3, Section 4, Section 5
5. Telemedicine Practice Guidelines issued by the Board of Governors in Supersession
of the Medical Council of India
6. Compliance with the upcoming Digital Personal Data Protection Bill, 2022 and IS
17428 Standard, - Section 4.2.3, Part I : IS 17428 ; Section 5, Digital Personal Data
Protection Bill, 2022.

Section 4.2.2, Part I: IS 17428, Section 6, Digital Personal Data Protection Bill, 2022.

Section 5.9, Part I: IS 17428

7. E-commerce entities are obligated to comply with the Information Technology


(Reasonable security practices and procedures and sensitive personal data or
information) Rules, 2011, which governs provisions relating to processing, collection
and usage of personal information and sensitive personal information.
8. Payment gateway operators must obtain necessary authorisations, comply with
security standards such as PCI DSS, and monitor transactions for fraudulent
activities.They need to have effective dispute-resolution mechanisms, comply with
Know Your Customer (KYC), Anti Money Laundering (AML) and Combating
Financing of Terrorism (CFT) requirements, and adhere to settlement timelines and
data localisation rules.

https://rbidocs.rbi.org.in/rdocs/notification/PDFs/NT17460E0944781414C47951B6D
79AE4B211C.PDF
Section 1.2 and 1.5, Annexure 2, Section 10., Section 5.3, Section 6, Section 8.4
9. IPR and Marketing Legal Compliances- Section 18, The Trade Marks Act, 1999,
Section 45, The Copyright Act, 1957, Section 3, The Patent Act, 1970.
10. Compliance with advertising standards set by the Advertising Standards Council of
India (ASCI)

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