Public Participation On Digital Health Act Regulations Begins Dec 9

The government is inviting the public to provide feedback on the proposed Digital Health Act regulations starting December 9.

Health Cabinet Secretary Deborah Barasa, in an announcement published in local newspapers, shared that the Ministry of Health and other national and county government stakeholders have developed three sets of draft regulations under the Digital Health Act.

The regulations being reviewed are: 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.

Public participation will run from December 9 to 19, 2024, in various regions across the country. The meetings will be held in two sessions each day.

“Additionally, and pursuant to the Statutory Instrument Act, 2013, the Cabinet Secretary and the Digital Health Agency plans to engage members of the public and stakeholders on the same through public hearings in two sessions,” the notice read.

The first session, from 9 am to 12 noon, will involve briefings on the provisions of the Digital Health Act, the draft regulations, and the regulatory statement. The second session, from noon to 5 pm, will allow members of the public and stakeholders to make oral submissions.

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This initiative follows President William Ruto’s signing of the Health Digital Act into law on October 19, 2023. The Act is designed to create a comprehensive digital health infrastructure, improve data governance, and foster innovation in healthcare delivery.

A central component of the Act is the establishment of the Digital Health Agency, which will oversee the provision of digital health services, ensure secure transfer of health data, and develop an integrated digital health information system. This agency will play a key role in improving the efficiency and integration of healthcare services in the country.

The Act is guided by principles that include recognizing health data as a national asset, ensuring the privacy and security of health data, and facilitating data sharing for informed decision-making. These principles are intended to ensure that digital health serves the healthcare sector equitably and progressively.

In addition to these key principles, the Act provides for the development of standards and guidelines for the e-Health platform, sets out regulations for e-waste management, and allows for the licensing of foreign facilities by equivalent regulatory authorities recognized in Kenya.

While the Digital Health Act holds significant promise for enhancing healthcare delivery and positioning Kenya as a leader in digital health, it also raises concerns regarding data privacy and security. Therefore, strict regulations and controls will be necessary to protect individuals’ health data, prevent data breaches, and ensure that the digital health ecosystem remains secure and effective.