Important Government Digital Healthcare Policies, Regulations and Initiatives You Should Know:

Digital Health and Digital Healthcare are rapidly transforming the healthcare landscape in India. Digital health India initiatives, backed by the government and embraced by the healthcare industry, are paving the way for a more personalized, accessible, and efficient healthcare system. This blog introduces the digital healthcare in India, exploring initiatives, policies, healthcare industry regulations and standards like the National Digital Health Mission (NDHM), Personal Health Records (PHRS), and Electronic Health Records Standards (EHRS).

Digital Healthcare

National Digital Health Mission (NDHM):

Launched in 2020, this flagship program aims to create a nationwide digital health ecosystem. It includes:

  • Ayushman Bharat Health Account (ABHA):

    A unique digital health ID for every citizen, allowing them to store and access their health records online.

  • Health Facility Registry (HFR):

    A registry of all healthcare providers in the country.

  • Health Professional Registry (HPR):

    A registry of all healthcare professionals.

  • Personal Health Records (PHRs):

    A repository of individual health data controlled by the user.

  • e-Pharmacy:

    A platform for online purchase of medicines.

Telemedicine Practice Guidelines (TPG):

Issued in 2020, these guidelines regulate the practice of telemedicine in India, ensuring quality and ethical care.

Digital Health Mission (DHM):

This scheme aims to create a network of telemedicine hubs in rural and remote areas, providing access to specialist consultations regardless of location.

National Health Stack (NHS):

This framework outlines the architecture and standards for the digital health ecosystem, ensuring interoperability and data security.

Health Data Management Policy (HDMP):

This policy establishes principles for data privacy and security in the digital health ecosystem.

DISHA Bill:

This proposed legislation aims to regulate the collection, storage, and use of digital health data, providing a legal framework for data protection.

Other Initiatives:

  • Government is promoting the development of affordable EHR/EMR systems for smaller healthcare providers.
  • Incentives are being offered to encourage EHR/EMR adoption and telemedicine usage.
  • Training programs are being conducted to improve digital literacy among healthcare professionals.

Standards and Regulations related to Health and Medical records:

Healthcare providers should be aware of standards and best practices for managing EHRs.

Electronic Health Record (EHR) Standards for India:

These standards, published by the Ministry of Health and Family Welfare, specify:

  • Data elements: The minimum set of data elements that should be included in an EHR.
  • Data format: The format in which the data should be stored (e.g., HL7 FHIR).
  • Security: The security measures that should be implemented to protect patient data.
  • Interoperability: The requirements for EHR systems to exchange data with other systems.

Clinical Establishment (Registration and Regulation) Act (2010):

This Act requires healthcare facilities to maintain medical records in a prescribed format, which can be electronic.

Drugs and Cosmetics Act (1940):

This Act regulates the storage and transmission of electronic patient records containing information about prescribed drugs.

Indian Penal Code (IPC):

This code includes provisions for penalties related to data breaches and unauthorized access to electronic records.

Meaningful Use Stage 3 (MU3):

This program, while not directly applicable in India, outlines best practices for using EHRs to improve patient care.

HIMSS Electronic Health Record Adoption Model (EHRA Model):

This model provides a framework for assessing the maturity of EHR adoption and implementation.

SNOMED CT:

This standardized terminology is used to represent medical concepts in EHRs, ensuring consistency and accuracy.

By adhering to these standards and best practices, healthcare providers can ensure their EHR systems are secure, reliable, and interoperable, ultimately improving patient care and outcomes.  Below are some reference links and other important resources for all healthcare providers and patients to know.  Should you require any assistance, our expert team is ready to help. Contact us today to ensure your digital health solutions are compliant. 

Useful Resources:

National Digital Health Mission (NDHM):

Telemedicine Practice Guidelines (TPG):

Digital Health Mission (DHM):

National Health Stack (NHS):

Health Data Management Policy (HDMP):

DISHA Bill:

Resources related to Electronic Health Records:

Electronic Health Record (EHR) Standards for India:

Clinical Establishment (Registration and Regulation) Act (2010):

Drugs and Cosmetics Act (1940):

Indian Penal Code (IPC):

Meaningful Use Stage 3 (MU3):

(While not directly applicable in India, it offers valuable best practices)

HIMSS Electronic Health Record Adoption Model (EHRA Model):

SNOMED CT:

Personal Data Protection Bill (2022): 

(Proposed law, important to keep an eye on updates) 

Additional Resources: