PUBLIC PARTICIPATION AND STAKEHOLDER ENGAGEMENT ON DRAFT REGULATIONS FOR THE DIGITAL HEALTH ACT, 2023 AND THE DRAFT REGULATORY IMPACT STATEMENT

The Digital Health Act No. 15 of 2023 was enacted on the 19th October,
2023. The Act confers upon the Cabinet Secretary for Health, in
consultation with the Digital Health Agency and the County Governments, the
power to make Regulations under section 60 for various matters required to
be prescribed under the Act, in particular, health information management
policies and procedures, the use of e-Health applications and technologies,
medical devices and innovations, data quality and data protection audits
and the establishment and implementation of the data exchange component as
per the Kenya Health Enterprise Architecture. To this end and pursuant to
section 60 of the Digital Health Act;

IT IS NOTIFIED for information of the general public that the Cabinet
Secretary for Health, in consultation with the Digital Health Agency and
the County Governments, through a Technical Working Group comprised of
officers from the Ministry of Health, the Council of Governors, County
Governments, the Digital Health Agency, the Office of the Attorney General
and Department of Justice, the Kenya Law Reform Commission and the National
Assembly, has developed the following three (3) sets of draft regulations
to the Digital Health Act:

1. The Digital Health (Health Information Management) Regulations, 2024
2. The Digital Health (Data Exchange) Regulations, 2024
3. The Digital Health (Use of e-Health Applications and Technologies)
Regulations, 2024

Link to the Notice:
health.go.ke/sites/default/files/2024-11/037DNC21112024.pdf

Lin to the Regulations: health.go.ke/social-health-regulations

The comments, views, representation and any written memoranda may be
forwarded to the Office of the Principal Secretary, State Department for
Medical Services, Nairobi; hand-delivered to the Office of the Principal
Secretary, State Department for Medical Services on Afya House 6th Floor,
Nairobi; or emailed to *[email protected]
<[email protected]>;* to be received on or before, *19th December,
2024, at 5:00 pm. *

Listers are encouraged to review and submit comments. You can share here
your views to be incorpoarated in the memorandum.

Regards,

*Victor Kapiyo*
Partner | *Lawmark Partners LLP*
*Nine Planet Apartments, Nairobi | **Web: www.lawmark.co.ke
<www.lawmark.co.ke/> *
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*“Your attitude, not your aptitude, will determine your altitude” Zig
Ziglar*