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Healthcare Data

This is a collection of proposals, initiatives, and recommendations that shape Indian policy concerning healthcare data

Published onApr 02, 2020
Healthcare Data


Electronic Health Records Standards in India, 20161

These standards lay down the basic standards that need to be followed for identifications and demographics, patient identifiers, architecture requirements, functional requirements, reference model and composition, terminology, coding system, scanned or captured records, data exchange, discharge, treatment summary, e-prescription, personal healthcare and medical device interface, data privacy and security, information security management, privilege management and access control, data integrity, data encryption and digital certificate.

It also lay down interoperability standards, medical terminology and coding standards, data exchange standards, data ownership, data access and confidentiality, responsibility of healthcare providers, privileges of patient or personal representative, denial of information, electronic medical records preservation, patient identifying information, security of electronic health information , etc.

The Standard also lays down the ethical, legal, social issues (ELSI) guidelines which prescribes that only the patient shall have access to his own data. All recorded personally identifiable data will at all times be protected from any unauthorized access. It defines Protected Health Information (PHI) as any individually identifiable information whether oral or recorded in any form or medium.

The National Ethical Guidelines For Biomedical and Health Research Involving Human Participants by The Indian Council Of Medical Research 20172

These guidelines lay down the principles to be followed while conducting any research or experimentation on human participants. As a general principle, the privacy and confidentiality of potential participants, their identity and records must be kept confidential and the access is limited. However, under certain circumstances (suicidal ideation, homicidal tendency, HIV positive status, when required by court of law etc.) privacy of the information can be breached in consultation with the EC for valid scientific or legal reasons. Further, the principles of transparency and accountability must be followed throughout.

Any publication arising out of research should uphold the privacy of the individuals by ensuring that photographs or other information that may reveal the individual’s identity are not published. While conducting research with stored biological samples or medical records/data, coding or anonymization of personal information is important and access to both samples and records should be limited.

The Guidelines stipulate the regulations to be followed for data acquisition, management, sharing, data ownership, data to be used for research, quality of data, prior authorization for data collection, data protection and storage, and steps for responsible data handling. It lays prohibits research misconduct, which has been defined through the Regulations.

The Regulations also lay down the procedure for Registration with Clinical Trials Registry in India. The Clinical Trials Registry is a free and online public record system for registration of clinical trials. Trial registration in the CTRI was made mandatory by the Central Drugs Standard Control Organisation (CDSCO) for clinical trials that are registered under the Drugs and Cosmetics Act and its Rules. Registration with CTRI is voluntary for other biomedical and health research.

All clinical research involving human participants including any intervention such as drugs, surgical procedures, devices, biomedical, educational or behavioural research, public health intervention studies, observational studies, implementation research and preclinical studies of experimental therapeutics and preventives or AYUSH studies may be registered prospectively with the CTRI.

Trial registration involves providing information regarding the study, investigators, sites, sponsor, ethics committees, regulatory clearances, disease/condition, types of study, methodologies, outcomes, etc. Registration of research in CTRI ensures that such data for research is readily available publicly, in order to improve transparency, accountability and accessibility.

The Guidelines also lay down the ETHICAL REVIEW PROCEDURES and the information to be submitted for proposal. It stipulates in detail the informed consent process, and specific guidelines for vulnerable groups.

Further, the Guidelines lay down the rules for PUBLIC HEALTH RESEARCH. It stipulates the potential surveillance, programme monitoring data and programme evaluations. It enlists the data to be collected in terms of health status, risk factors, health service access and utilization, the data to be used by researchers, and screening the documents and observations.

Further, it lays a procedure to be followed for demographic surveillance sites and registries. The aim of a surveillance site is to provide an evidence base for improving the lives of people living in developing countries by informing and influencing existing as well as future health-related policy and practice. Appropriate EC review is required for research studies to be undertaken at these sites including data-set collection and its storage, with plans to maintain confidentiality. To safeguard the confidentiality of personally identifiable records, the collected data at demographic sites must be stored in an encrypted format with primary identifiers accessible only to restricted designated individuals who are bound by a confidentiality agreement.

Registries that are set-up as part of public health programmes by a national authority may be exempted from the ethical review process if the data is de-identified. It also lays down the use of administrative and other data sources for research. There is a shift in use of these data sets, from primarily managing and monitoring programmes and performing audits, to conducting research and informing policy. Large volume of data may be accessible from state health departments, national surveys, commercial sources and other data repositories and big data sources.

The Guidelines lay down the procedures to be followed for human genetics testing and research. It prescribes the rules for privacy and confidentiality of data, collection of information (including family history), non-disclosure of information, data storage, transfer/ sharing of biological material and data with laboratories, handling IPR, etc.

The Guidelines lay down the procedures to be followed for biological materials, biobanking and datasets. It stipulates the information collected, information storage, use of data and its potential for research. A biobank is an organized collection of human biological materials with usually associated dataset stored for years in appropriate facilities for research and potential commercial purposes with inbuilt policies for transparency. It involves governance of collection of biological material, processing, storage with associated data, and dissemination of samples and/or data through sharing. The Guidelines stipulate the size and use of data stored in the biobanks.

The Guidelines also lay down the procedure to be followed for protecting the privacy of the donor and confidentiality related to biological materials and/or data. It stipulates the storage of biospecimens and data with personal identifiers, informed consent, confidentiality, and re-consent, anonymization of data, degree of identifiability of data, data mining and other data science tools that can be employed, formats for storage of data and contingency plan for sustainability of the biobanks.

Good Clinical Practice by the Central Drugs Standard Control Organization

An Expert Committee set up by Central Drugs Standard Control Organisation (CDSCO) in consultation with clinical expert has formulated this Good Clinical Practice (GCP) guideline for generation of clinical data on drugs. 

The GCP Guidelines lay down rules to be followed for confidentiality, Quality Assurance (QA) , Quality Control (QC), rata Randomisation, raw data, source data,  pre-clinical supporting data, data handling and management, quality control and quality assurance , finance and insurance, ethical & safety considerations, ethical principles, principles of privacy and confidentiality, principles of accountability and transparency, study management, data handling and record keeping, maintenance of  records/reports, record keeping and data handling, documentation, correction,  electronic data processing, validation of electronic data processing systems, responsibilities of the investigator.

National Policy for Persons with Disabilities, 20063

The Policy emphasis on the need for regular collection, compilation and analysis of data relating to socioeconomic conditions of persons with disabilities. The National Sample Survey Organization has been collecting information on Socio-economic conditions of persons with disabilities on regular basis once in ten years since 1981. The Census has also been collecting information on persons with disabilities from the Census-2001.

The National Sample Survey Organization collects the following information on persons with disabilities: the socio- economic and cultural context, cause of disabilities, early childhood education methodologies and all matters connected with disabilities, at least once in five years. It also places limitations on the information collected, and limitations for use of information.

Developing Trauma Care Facilities in Government Hospitals in National Highways

This scheme was introduced to establish a network of trauma centres in order to reduce the incidence of preventable death due to road traffic accidents and to develop National Trauma Injury Surveillance and Capacity Building Centre for collection, compilation, analysis of information from the trauma centres for the use of policy formation, preventive interventions. The data collected is used for analysis on injury surveillance.

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