On November 21, 2024, the Ministry of Health announced that it had launched a public consultation on three draft regulations to the Digital Health Act, namely the Digital Health (Health Information Management) Regulations 2024, the Digital Health (Data Exchange) Regulations 2024, and the Digital Health (use of e-Health Applications and Technologies) Regulations 2024.

The Digital Health (Health Information Management) Regulations 2024 (the Health Information Management Regulations)

The Health Information Management Regulations apply to the management of health information and health data, processing of personal health data, and handling of complaints arising from the use, access, and management of health information. Specifically, the Health Information Management Regulations provide requirements and obligations for the management, security, privacy, archiving, migration, access, and sharing of health data, as well as the management of complaints related to these processes.

The Digital Health (use of e-Health Applications and Technologies) Regulations 2024 (the e-Health Regulations)

The e-Health Regulations provide for the use of e-health applications and technologies, including digital health solutions in the provision of e-health. Among other things, the e-Health Regulations require that a digital health solution used in the provision of healthcare services must be certified by the Digital Health Agency. The Regulations further provide that a health data controller or a health data processor using or accessing the Comprehensive Integrated Health Information System established under Section 15(1)(a) of the Digital Health Act, No. 15 of 2023, shall only use a digital health solution that has been certified by the Digital Health Agency based on the Certification Framework developed and published by the Digital Health Agency every two years.

The Digital Health (Data Exchange) Regulations 2024 (the Data Exchange Regulations)

The Data Exchange Regulations set out:

• the administration and management of the Comprehensive Integrated Health Information System (CIHIS);
• the exchange of health information within the CIHIS; and
• the roles and responsibilities of the Digital Health Agency and other users of the CIHIS, including health data controllers, health data processors, patients or clients, and digital health solution providers.

Additionally, the Data Exchange Regulations require health data controllers who have been using or managing health data using a digital health solution to, within six months upon the coming into force of the Data Exchange Regulations, be onboarded into the CIHIS.

Comments can be submitted to [email protected] until December 19, 2024.

You can read the press release here, the Health Information Management Regulations here, the e-Health Regulations here, and the Data Exchange Regulations here.