The Bureau of Indian Standards (BIS) under the Department of Consumer Affairs has announced the scrapping of a series of health informatics standards. This step has been taken as part of the implementation of sub-rule (1) of rule (15) of the Bureau of Indian Standards Rules, 2018. These standards, which were previously adopted to guide various health informatics and medical device communication practices, will no longer apply as of March 19, 2025. The withdrawn standards cover a wide range of topics in health informatics, including medical device communications, electronic health records, data protection, and patient safety for health software. These standards were part of global efforts to ensure the smooth functioning and secure management of health-related data and devices.
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Implications for Health Informatics and Related Industries
The withdrawal of these standards could significantly impact manufacturers, healthcare providers, and developers involved in health informatics. Organizations that previously relied on these standards to guide their operations must now turn to BIS registration to ensure that their products and services meet the required quality and safety standards. With the cancellation of these standards, the focus may now shift toward obtaining updated BIS certifications or seeking alternative guidelines from BIS or other relevant regulatory bodies to ensure continued adherence to industry best practices and regulatory requirements.
Table of Withdrawn Standards
The following table lists the withdrawn standards along with their details:
| S.No. | No., Year & Title of the Indian Standard | Withdrawn Date |
| 1 | IS/ISO/IEEE 11073-30300 : 2004 Health Informatics -Point-of-Care Medical Device Communication Part 30300 Transport Profile -Infrared Wireless | 19th March 2025 |
| 2 | IS/ISO 12967-2 : 2009 Health Informatics -Service Architecture Part 2 Information Viewpoint | |
| 3 | IS/ISO 13606-1 : 2008 Health Informatics -Electronic Health Record Communication Part 1 Reference Model | |
| 4 | IS/ISO 13606-5 : 2010 Health Informatics -Electronic Health Record Communication Part 5 Interface Specification | |
| 5 | IS/ISO 17115 : 2007 Health Informatics -Vocabulary for Terminological Systems | |
| 6 | IS/ISO 17432 : 2004 Health Informatics -Messages and Communication -Web Access to DICOM Persistent Objects | |
| 7 | IS/ISO 22857 : 2013 Health Informatics -Guidelines on Data Protection to Facilitate Trans-border Flows of Personal Health Data | |
| 8 | IS/ISO/TS 25238 : 2007 Health Informatics -Classification of Safety Risks from Health Software | |
| 9 | IS/ISO/TR 27809 : 2007 Health Informatics -Measures for Ensuring Patient Safety of Health Software |
Next Step for the Stakeholders
As the health informatics landscape continues to evolve, stakeholders in the industry are encouraged to stay informed of updates and new standards being released by the BIS. It is critical for health technology-related organizations to adapt to changing regulatory requirements, to ensure compliance with any new guidelines that may replace or build on withdrawn standards.
The BIS plays an essential role in the standardization of products and services, and this recent update serves as a reminder of the importance of staying up to date with industry developments. The registration process will continue to be important for organizations to maintain high standards of quality, security, and compliance in the field of health informatics.
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