The E-Health Bill, 2023
Status Timeline
Proposed
Active now
Public Review
Pending
Debate
Pending
Executive
Pending
Final
Pending
Practice Restricted to Licensed Providers
Under Clause 12 and 13, only healthcare providers and institutions holding valid licenses from their respective regulatory bodies are permitted to practice telemedicine or m-Health services. All providers must register in the prescribed manner and secure written, legal consent from patients before capturing or recording their health information.
Establishment of a National Health Identifier System
Clause 18 mandates the Cabinet Secretary, in collaboration with the Council of County Governors, to establish a unique national health identifier system. Every healthcare recipient, individual provider, and healthcare organization will be assigned a unique national health identifier to facilitate secure, patient-centered care.
KSh 5 Million Penalty for Unlicensed E-Waste Handling
Under Clause 28, individuals or entities are prohibited from directly or indirectly handling health-related e-waste unless licensed by the National Environmental Management Authority (NEMA). Violators face a fine of up to KSh 5 million, imprisonment for up to three years, or both.
Accreditation Requirements for Health Tourism
Clause 34 requires health facilities or providers engaged in health tourism to obtain accreditation from the Medical Practitioners and Dentists Council. Performing health tourism services without this accreditation is an offence carrying a fine of up to KSh 5 million, a prison term of up to three years, or both.
Bill No.
Senate Bills No. 32
Gazette No.
Supplement No. 117
Sponsor
Hamida Kibwana
Background
The E-Health Bill, 2023 is introduced to give legislative effect to Section 104 of the Health Act, 2017, which recognizes the importance of e-Health and requires dedicated legislation to enhance it. The Bill seeks to facilitate the integration of information and communication technologies (ICT) within Kenya's healthcare system to ensure affordable, equitable, and secure healthcare delivery.
Key Amendments
While the Bill is a standalone Act, it directly references and interacts with several existing statutes to construct its regulatory framework:
- The Health Act (No. 21 of 2017): Aligns the duties of e-Health providers with patient rights and general provider duties under the principal Health Act.
- The Data Protection Act (No. 24 of 2019): Clause 42 explicitly applies the provisions of the Data Protection Act to all collection, processing, and transmission of personal health data.
- Sustainable Waste Management Act (No. 31 of 2022) & Environmental Management and Co-ordination Act (No. 8 of 1999): Frameworks from these acts govern the licensing of e-waste handling by NEMA.
- Medical Practitioners and Dentists Act (Cap. 253): Empowers the Medical Practitioners and Dentists Council to oversee the accreditation and regulation of health tourism.
- Health Records and Information Managers Act (No. 15 of 2016): Integrates standards for county health registries and data stewardship.
New Obligations
For National and County Governments
- National Government Responsibilities: Must develop national standards, ethical frameworks, and ICT security guidelines for e-Health services.
- County Government Responsibilities: County Executive Committee (CEC) members must implement national standards, ensure infrastructure accessibility, and may establish a County Health Data Stewardship Committee to manage health data disclosure applications.
For Healthcare Providers
- Consent and Confidentiality: Providers must obtain written legal consent from patients before recording or capturing data.
- E-Health Databases: Each provider must maintain a confidential e-health database containing the patient's national health identifier, physical address, family medical history, and clinical details. Providers are expressly prohibited from displaying or requiring a patient's ethnicity.
- System Interoperability: Systems must be designed to safely share data across geographical and health sector boundaries using standard data structures.
For Specialized Operators
- E-Waste Handlers: Must secure a license from NEMA and submit monthly returns to the Ministry of Health. Licenses expire annually on June 30th.
- Health Tourism Operators: Must be accredited by the Medical Practitioners and Dentists Council and submit monthly returns to the Ministry of Health.
Penalties
- Unlicensed E-Waste Handling: Any person or entity handling health-related e-waste without a license from NEMA commits an offence and is liable on conviction to a fine not exceeding KSh 5 million, imprisonment for a term not exceeding three years, or both (Clause 28(4)).
- Unaccredited Health Tourism: Any health facility or provider conducting health tourism without accreditation from the Medical Practitioners and Dentists Council faces a fine not exceeding KSh 5 million, imprisonment for up to three years, or both (Clause 34(4)).
- General Complaints: Aggrieved patients may file complaints under the procedure established in Section 14 of the Health Act.
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