An Act of Parliament to provide for the establishment of the Digital Health Agency; to provide a framework for provision of digital health services and to establish a comprehensive integrated digital health information system.
| PROPOSED PROVISION FOR AMENDMENT | PROPOSED AMENDMENT | OUR COMMENTS |
Clause 2 Interpretation | “anonymization” means the removal of personal identifiers from personal data so that the data subject is no longer identifiable. | Anonymization helps to protect the privacy of individuals by ensuring that their personal data cannot be used to identify them. This is especially important when handling sensitive information. |
“data analysis” means the process of inspecting, cleaning, transforming, consolidation and modelling of data with the goal of discovering useful information, extracting meaningful insights, suggesting conclusions and supporting decision making. | We propose the deletion of this term as it has not been used in the Bill. |
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“data bank” means an organised collection of data designed to efficiently store and retrieve data that can be accessed, managed and updated electronically to allow users to easily search for and access the information they need, to derive insights, make informed decisions and improve performance. | A data bank provides tools and systems for efficient data management, including data storage, indexing, categorization and retrieval, which can streamline data-related tasks. |
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“data controller” means a natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purpose and means of processing of personal data. | We propose the deletion of this term. The term “health data controller” has already been defined in the Bill. To streamline the Bill, we propose that the term “data controller” is deleted throughout the Bill and replaced with the term “health data controller”. |
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“data disposal” means the process of destroying manual or electronic records or data completely without being used or accessed for an authorized purpose. | Data disposal ensures that personal data is not accessible to unauthorized individuals when destroying manual or electronic records. |
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“data integrity” means the overall completeness, accuracy and consistency of data. | We propose the deletion of this term as it has not been used in the Bill. |
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“data privacy” means the aspect of information technology that deals with the ability an organization or individual has to determine what data in a computer system can be shared with third parties for purposes of the keeping of information private and safe. | Data privacy safeguards the data subjects’ personal data from unauthorized access or misuse. |
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“data security” means protection of electronic health data, and specifically the means used to protect the privacy of health information contained in electronic health data that supports professionals in holding that information in confidence. | Data security safeguards sensitive and confidential information from unauthorized access, disclosure or theft. Secondly, robust data security measures reduce the risk of data breaches, which lead to significant financial losses, damage to reputation and potential lawsuits. |
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“data storage” means the recording of information in a storage medium or holding information in digital format. | Data storage ensures the long-term preservation of critical information. Without proper data storage mechanisms, data can be lost due to hardware failures, accidental deletions or other unforeseen events. |
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“data subject” means an identified or identifiable natural person who is the subject of personal data. | This definition has been included as a data subject is the owner of the personal data being processed. |
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“data verification” includes the authentication and validation of gathered data, data quality checks, audit of the health data using the data quality protocols. | We propose the deletion of this term as it has not been used in the Bill. |
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“data processor” means a natural or legal person, public authority, agency or other body which processes personal data on behalf of the data controller. | The bill has relied on the definition used in section 2 of the Data Protection Act. This is an attempt by the Bill to align itself with the Data Protection Act to prevent a potential conflict of laws in the future once the Bill is assented. |
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“digital health” means the field of knowledge and practice that is associated with the development and use of digital technologies to improve health. | Digital health generates vast amounts of data, which can be analyzed to identify trends, patterns and insights. Health care providers can use this data to make informed decisions, develop evidence-based treatment plans and improve patient outcomes. |
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“disclosure” means submission of relevant information to an authorized party. | This means that sensitive and confidential information can only be accessed if the authorized party has obtained express approval to access the confidential information. |
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“e-Health” means the combined use of electronic communication and information technology in the health sector including telemedicine. | e-Health can bridge geographical barriers and increase access to health care services. This ensures that patients in remote areas can access health care services. |
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“e-Health ecosystem” means the combined application of e-Health infrastructure, standards, technology, systems applications, investment, health workforce and governance that support patient-centred models of healthcare. | An e-Health ecosystem increases access to health care services, particularly for undeserved or remote populations who may have limited access to traditional health care facilities. |
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“e-Health platform” means an ecosystem of hardware, software and technology used to deliver e-Health services. | e-Health platforms play a critical role in modern healthcare, supporting the delivery of patient-centered care, improving healthcare access and enabling data-driven decision making for better health outcomes. |
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“electronic health data” means an electronic record of personal health related information about an individual and shall include: a. information concerning the physical or mental health of the individual; b. information concerning any health service provided to the individual; c. information concerning the donation by the individual of any body part or any bodily substance; d. information derived from the testing or examination of a body part or bodily substance of the individual; e. information that is collected in the course of providing health services to the individual; or f. information relating to details of the health facility accessed by the individual. | Electronic health data provide healthcare providers with instant access to comprehensive patient information. This enables healthcare providers to make informed and timely clinical decisions. Secondly, electronic health data reduces the risk of medical errors by providing accurate and up-to-date information on patient allergies, medications and medical history. |
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“encryption” means the process of converting the content of any readable data using technical means into coded form. | Encryption safeguards data by making it unreadable to anyone who does not possess a decryption key. This ensures that data is protected even if its stolen. Secondly, sensitive information can be kept private through encryption, preventing unauthorized individuals from accessing it. |
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“enterprise service bus” means an architectural pattern whereby a centralized software component performs integrations between applications; transformations of data models, handles connectivity, message routing, converts communication protocols and potentially manages the composition of multiple requests and may make these integrations and transformations available as a service interface for reuse by new applications. | An enterprise service bus provides a centralized platform for managing and routing data. This ensures there is seamless and efficient communication within an organization. |
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“enterprise class” refers to applications that are designed to be robust and scalable across a large organization: Compatible with existing databases and tools, customizable for the needs of specific departments, powerful enough to scale up along with the needs of the business using it, secure from outside threats and data leaks. | We propose the deletion of this term as it has not been used in the Bill. |
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“e-waste” means waste resulting from electrical and electronic equipment including components and sub-assemblies thereof. | Proper disposal of electronic devices ensures that confidential information cannot be accessed by unauthorized persons. |
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“health care services” means the prevention, promotion, management or alleviation of disease, illness, injury, and other physical and mental impairments in individuals, delivered by health care professionals through the health care system's routine health services, or its emergency health services. | This definition provides a scope of services offered by health care providers and health care professionals. |
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“health data” means data related to the state of physical or mental health of the data subject and includes records regarding the past, present or future state of the health, data collected in the course of registration for or provision of health services or data which associates the data subject the provision of specific health services. | This definition provides a scope on the data that can be collected from a data subject undergoing medical treatment. |
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“health data controller” means a natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purpose and means of processing of health data. | A health data controller is responsible for determining the means in which personal health data will be processed. This accountability ensures that personal health data is handled in a lawful and ethical manner. |
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“health data processor” means a person, public authority, agency or other body who is an authorised worker to process health data. | Their expertise is essential for health care providers to effectively harness the value of health data while safeguarding patient privacy and complying with regulatory requirements. |
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“health facility” means the whole or part of a public or private institution, building or place, whether for profit or not, that is operated or designed to provide in-patient or out-patient treatment, diagnostic or therapeutic interventions, nursing, rehabilitative, palliative, convalescent, preventive or other health services. | This definition outlines the range of services that can be provided within the health facility. This ensures that it operates within its authorized scope of practice. |
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“health information bank” means an electronic database under the custody and control of the Ministry of Health, county director for health and county health departments, that contains personal health information and is designated by the Cabinet Secretary as a health information bank. | A health information bank provides health care providers with access to comprehensive patient information, including medical history, test results and treatment records. This enables more informed and timely medical decisions to be made. |
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“health informatics” means the practice of acquiring, studying and managing health data and applying medical concepts in conjunction with health information technology systems to help clinicians provide better healthcare. | Health informatics optimizes administrative and clinical processes. This reduces paperwork, duplication of tasks and wait times, resulting in more efficient health care delivery. |
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“health records and information management” means the practice of acquiring, analysing, and protecting digital and traditional medical information vital to providing quality patient or client care. | We propose the deletion of this term as it has not been used in the Bill. |
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“health records and information manager” means an officer trained in health records and information and charged with the responsibility of managing health records and health information for the health services which include: a. creating and enforcing policies for effective data management; b. clinical coding and classifications; c. coding for health insurance firms; d. health information management; e. health administrative data and medical data analytics and research; f. appraisal of medical documentations and audits; g. advice on medical legal issues; h. advise on retrieval and disposal of health and medical records; and i. use of e-Health applications. | We propose the deletion of this term as it has not been used in the Bill. |
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“health related data information” means the service delivery and administrative health data collected, analysed and synthesised for decision making in the health sector. | We propose the deletion of this term as it has not been used in the Bill. |
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“health tourism” means a situation where a patient travels voluntarily across international borders to receive medical treatment. | Health tourism allows patients to access medical facilities and expertise that may not be available or easily accessible in their home countries. |
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“integrated e-Health information system” means a health information system that collects health and health related data that addresses the needs of all users for decision making. | We propose the deletion of this term as it has not been used in the Bill. |
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“m-Health” means the delivery of medical services using mobile technologies. | m-Health improves health care access, especially in remote areas where access to health care services is limited. Secondly, patients can access health care resources and information anytime and anywhere using their smartphones. This reduces the need for physical visits to health care facilities. |
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“personally identifiable information” means information that can be used to uniquely identify, contact or locate an individual, or can be used with other sources to uniquely identify a person. | We propose the deletion of this term as it has not been used in the Bill. |
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“private health services” means provision of health services by a health facility that is not owned by the national or county governments and includes health care services provided by individuals, faith-based organizations, non-governmental organizations and private for profit health institutions. | We propose the deletion of this term as it has not been used in the Bill. |
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“processing” means any operation or sets of operations which is performed on personal data or on sets of personal data whether or not by automated means including: a. collection, recording, organisation, structuring; b. storage, adaptation or alteration; c. retrieval, consultation or use; d. disclosure by transmission, dissemination, or otherwise making available; or e. alignment or combination, restriction, erasure, or destruction. | This definition provides the methods that may be used by data health processors to process the data subjects’ health data. |
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“public health services” means health services owned and offered by the national and county governments. | We propose the deletion of this term as it has not been used in the Bill. |
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“referral” means the process by which a given health facility transfers a client service, specimen and client parameters to another facility to assume responsibility for consultation, review, or further management. | Health care providers may refer patients to specialists when the patient’s condition requires specialized expertise or treatments that are beyond their own scope of practice. Secondly, in cases where treatment decisions are complex or involve high risks, a patient may seek a second opinion from another health care provider to suggest a recommended course of action. |
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“research for health” includes research which seeks to contribute to the extension of knowledge in any health related field, such as that concerned with the biological, clinical, psychological or social processes in human beings improved methods for the provision of health services; or human pathology; or the causes of disease; or the effects of the environment on the human body; or the development or new application of pharmaceuticals, medicines and other preventative, therapeutic or curative agents; or the development of new applications of health technology. | Research for health leads to the development of new treatments that improve patient outcomes and enhance the quality of medical care. Secondly, research for health results in more accurate and advanced diagnostic tools that enable earlier disease detection and more precise diagnoses. |
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“system integration” refers to the merging or combining of two or more components or configuration items into a higher level system element and ensuring that the logical and physical interfaces are satisfied and that the integrated system satisfies its intended purpose. | System integration has the following benefits: a. it eliminates redundant tasks and processes, leading to increased efficiency and productivity; b. It eliminates the need for duplicate data entry and storage, leading to reduced costs in the long run; and c. changes made in one system are reflected in others in real time. This ensures that everyone has access to the most current data. |
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“system interoperability” refers to the capability to communicate, execute programs or transfer data among various functional units such that the user needs little or no knowledge of the unique characteristics of those units. | System interoperability streamline processes by allowing data to flow seamlessly between systems and applications. This reduces manual data entry, duplication of effort and the risk of errors, ultimately leading to increased efficiency. |
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“telemedicine” refers to the provision of health care services and sharing of medical knowledge over distance using telecommunications and it includes consultative, diagnostic, and treatment services. | Telemedicine improves access to health care, particularly in rural or undeserved areas where health care facilities is scarce. Patients can receive medical advice and consultations without the need for long distance travel. |
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Clause 3 Objects of the Act | The objects of this Act are to: a. establish the Digital Health Agency; b. establish and maintain a comprehensive integrated health information system; c. promote innovation and the safe, efficient and effective use of technology for healthcare, including for continuity of care, emergency and disaster preparedness, and disease surveillance; d. establish a regulatory framework for the e-Health ecosystem data lifecycle; e. provide for privacy, confidentiality, and security of health data; f. develop standards for the provision of m-Health, telemedicine, and e-Learning; g. establish a regulatory framework for e-waste management; and h. provide for the safe and secure transfer of personal, identifiable health data and client’s medical records to and from health facilities outside Kenya. | The objects of the Bill have been stated to provide a framework for the provision of digital health services which will enhance the quality of digital health care services provided to patients. Secondly, objects outline the goals or aims that the Bill seeks to achieve. By clearly stating the objects of the Bill, it helps in interpreting and understanding its provisions. To conclude, objects ensure that the Bill is effectively implemented, applied consistently, and aligned with its intended purposes. |
Clause 4 Guiding principles | In implementing the Act, all persons shall be guided by the following principles: a. health data is a strategic national asset; b. safeguard of the privacy, confidentiality and security of health data for information sharing and use; c. digital health should facilitate data sharing and use for informed decision-making at all levels; and d. the digital health ecosystem which serves the health sector and facilitates in a progressive and equitable manner, the highest attainable standard of health. | Guiding principles provide clarity about the intent and purpose of the Bill. They help Parliament to articulate the fundamental values and goals the Bill aims to achieve, ensuring consistency in its interpretation and application over time. |
PART II — ESTABLISHMENT OF THE DIGITAL HEALTH AGENCY |
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Clause 5 Establishment of the Digital Health Agency | There is established an Agency to be known as the Digital Health Agency. The Agency shall be a body corporate with perpetual succession and a common seal and shall, in its corporate name, be capable of: a. suing and being sued; b. taking, purchasing or otherwise acquiring, holding, charging and disposing of movable and immovable property; c. receiving, investing, borrowing money; and d. doing or performing such other things or acts necessary for the proper performance of its functions under this Act. | The purpose of this clause is to give the Agency legal capacity to act in its own name. |
Clause 6 Functions of the Agency | The Agency shall: a. develop, operationalise and maintain the Comprehensive Integrated Management Information System, to manage the core digital systems and the infrastructure required for its seamless health information exchange; b. establish registries, in consultation with other statutory authorities, at appropriate level to create single source of truth in respect of clients, health facilities, healthcare providers, health products and technologies; c. promote adoption of best practices and standards for digital health that facilitate data exchange; d. establish a system of shareable and portable personal health records, based on best practices and standards; e. ensure health data portability; f. facilitate collection and analysis of data to inform policy and research in the health sector; g. promote the development of enterprise-class health application systems; h. strengthen existing health information systems by ensuring their conformity with the prescribed standards and integration with the Comprehensive Integrated i. develop and implement the infrastructure for health data exchange of health information in a secured manner; j. maintaining, in collaboration with the counties and other statutory authorities, the technological infrastructure necessary for the core digital health services; k. support the development and implementation of standards for enhanced interoperability; l. undertake resource mobilization for implementation of health digitization in the country; m. certify digital health solutions based on best practices and standards; n. advise the Cabinet Secretary on matters related to digital health; and o. perform any other function for the better carrying out of functions under this Act. | The functions are clearly stated to prevent the Agency from performing tasks that are ultra vires. |
Clause 8 Board of Directors | There shall be a Board of Directors of the Agency which shall consist of: a. a non-executive chairperson who shall be competitively recruited and appointed by the President; b. the Principal Secretary responsible for Health or a representative designated in writing; c. the Principal Secretary responsible for National Treasury or a representative designated in writing; d. the Principal Secretary responsible for Information, Communication and Technology or a representative designated in writing; e. the Data Commissioner or a representative designated in writing; f. one person nominated by the Council of County Governors; g. one person appointed by the Cabinet Secretary representing the private sector; h. two persons, not being public officers or employees of the Agency, to be appointed by the Cabinet Secretary by virtue of their knowledge and experience in digital health; and i. the Chief Executive Officer, who shall be an ex-officio member of the Board. The Chairperson of the Board and the members appointed under subsection (1)(a) and (i) shall serve for a term of three years and shall be eligible for re-appointment for one further term of three years. In appointing persons as members of the Board under subsection (1)(g) and (h), the Cabinet Secretary shall ensure that the appointments afford equal opportunity to men and women, youth, persons with disabilities, minorities and marginalized groups and ensure regional balance. A person appointed to the Board under sub-section (1)(a) and (i) shall cease to be a member of the Board if he: a. resigns in writing addressed to the Cabinet Secretary; b. is adjudged bankrupt; c. is absent without the permission from three consecutive meetings; d. is convicted of a criminal offence and sentenced to imprisonment for a term exceeding six months; or e. is unable to perform the functions of his office by reason of mental or physical infirmity. Despite subsection (4), the Chairperson or the member of the Board may be removed for: a. incompetence or neglect of duty; or b. gross misconduct whether in the performance of the members’ functions or otherwise. The First Schedule shall have effect with respect to the constitution or organization of the Board. The Agency shall pay to the directors such remuneration, fees or allowances for expenses as may be determined by the Cabinet Secretary on the advice of the Salaries and Remuneration Commission. The Board may co-opt any other person with necessary expertise as it necessary to assist the Board in discharging its duties and responsibilities. | For sub-clause (1) (g), we propose that the person appointed by the Cabinet Secretary to represent the private sector is appointed through a fair, transparent and competitive process. A fair, transparent, and competitive appointment process ensures that candidates are evaluated based on their qualifications, skills and experience. This helps to attract and select the most suitable individual, contributing to the overall effectiveness and efficiency of the organization. Secondly, this proposal ensures that appointments are done in a fair and transparent manner in accordance with the values and principles set out in the Constitution. |
The Board is comprised of ten members. The Chief Executive Officer does not have voting rights as he is an ex-officio member. This means that nine members vote when the Board makes its decisions. This is a good proposal. When there’s an even number of members who can vote, there’s a greater risk of deadlocks. This makes it difficult for the Board to make decisions, resolve conflicts, or move forward with its agenda. An odd number ensures that there will always be a majority decision. |
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The inclusion of the Salaries and Remuneration Commission in sub-clause (6) is a good proposal. This proposal will be in line with Article 230 (4) (a) of the Constitution which gives the Salaries and Remuneration Commission power to set and review the remuneration and benefits of all public officers. |
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Clause 10 Committees of the Board | The Board may from time to time establish such committees as it considers necessary for the better carrying out of its functions under this Act. The Board may co-opt into the membership of a committee established under sub-section (1) such other person whose knowledge and skills are found necessary for the functions of the Agency. | Co-opting allows the Board to bring in individuals with specialized expertise, knowledge or experience relevant to the Board’s tasks. This can be valuable when the existing Board members lack certain skills or expertise. |
Clause 11 Chief Executive Officer | There shall be a Chief Executive Officer who shall be appointed by the Board. Subject to this Act, the Chief Executive Officer shall be appointed on such terms and conditions of service as shall be determined by the Board in the instrument of appointment or otherwise in writing from time to time. | For sub-clause (2), we propose that the salary of the Chief Executive Officer is determined by the Board in consultation with the Salaries and Remuneration Commission. This proposal will be in line with Article 230 (4) (a) of the Constitution which gives the Salaries and Remuneration Commission power to set and review the remuneration and benefits of all public officers. |
Clause 12 Qualification for appointment as a Chief Executive Officer | A person shall be qualified for appointment as the Chief Executive Officer of the Authority if that person: a. has a minimum of a bachelor’s degree from a university recognized in Kenya; b. has at least ten years' knowledge and experience in health information science, data science, data governance, health informatics, digital health or any other relevant field; c. has not been convicted of an offence and is not serving a term of imprisonment; and’ d. meets the requirements of Chapter Six of the Constitution. The Chief Executive Officer shall, subject to the directions of the Board, be responsible for the day-to-day management of the affairs and staff of the Board. The Chief Executive Officer shall hold office for a period of three years and shall be eligible for re-appointment for one further term of three years. | Specifying qualifications in the Bill provides clear and standardized criteria for eligibility in a particular position. This clarity helps both applicants and decision makers understand the minimum requirements for the role. |
For sub-clause (1), we propose the deletion of the word “Authority” and replacing it with the word “Board”. The rationale for this proposal is that the Chief Executive Officer is a member of the Board as indicated in clause 8 (1) (i) of the Bill. |
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Clause 13 Corporation Secretary | There shall be a Corporation Secretary who shall be competitively recruited and appointed by the Board on such terms as the Board may, on the advice of the Salaries and Remuneration Commission, determine. | The Bill is incomplete. We propose adding the following information in the subsequent sub-clauses of this clause: a. the functions of the Corporation Secretary; b. the qualifications for appointment as a Corporation Secretary; and c. the grounds for removal from office. The above proposals enhance completeness and clarity by adding the necessary information that was omitted from this clause. |
Clause 14 Staff | The Board may appoint such staff as may be necessary for the proper discharge of the functions of the Agency under this Act, upon such terms and conditions of service as the Board may determine in consultation with the Salaries and Remuneration Commission. | This proposal will be in line with Article 230 (4) (a) of the Constitution which gives the Salaries and Remuneration Commission power to set and review the remuneration and benefits of all public officers. |
PART III — FINANCIAL PROVISIONS |
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Clause 15 Funds of the Agency | The funds of the Agency shall consist of: a. monies appropriated by Parliament for the purposes of the Agency; b. such monies or assets as may accrue to the Agency in the course of the exercise of its powers or in the performance of its functions under this Act; c. monies from any other source provided, donated, lent, or given as a grant to the Agency; and d. any other funds designated for or accruing to the Agency by virtue of the operation of law. There shall be paid out of the funds of the Agency all expenditure incurred, administrative expenses or for such other purposes as may be necessary for the discharge of the functions of the Agency in the exercise of its powers or the performance of its functions under this Act. | This clause indicates the methods in which the Agency can use to raise funds for conducting its activities. |
We propose the addition of a sub-clause allowing for investment of the Agency’s funds. Investing funds can generate income for the Agency. This additional income can support operations or be reinvested for growth. Secondly, investing funds can help preserve the Agency’s wealth by keeping pace with or outpacing inflation. Leaving money idle in low-yield accounts can lead to a loss of purchasing power over time. |
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Clause 17 Annual estimates | Before the commencement of each financial year, the Chief Executive Officer shall cause to be prepared estimates of the revenue and expenditure of the Agency for that year. The annual estimates shall make provision for all the estimated expenditure of the Agency for the financial year concerned and provide for: a. payment of salaries, allowances, gratuities, pensions and other charges in respect of the members of the Board and Agency; b. maintenance of buildings and grounds of the Agency; c. funding of training, research, and development of activities in relation to the organization and functioning of the Agency. The annual estimates shall be approved by the Board before the commencement of the financial year to which they relate and are submitted by the Chief Executive Officer for tabling in the National Assembly. The annual estimates, once approved by the Board, shall not be amended before being tabled in the National Assembly. No expenditure shall be incurred for the purposes of the Agency except in accordance with the annual estimates approved under subsection (3). | The annual estimates determine how much money is allocated to the Agency by the National Assembly. |
Clause 18 Accounts and audit | The Board shall cause to be kept all proper audit books and records of accounts of the income, expenditure, assets, and liabilities of the Agency. The accounts of the Agency shall be audited and reported upon in accordance with the Public Finance Management Act, 2012 and the Public Audit Act, 2015. | This clause ensures that monies spent and raised by the Agency can be tracked and accounted for. |
Clause 19 Annual report | At the end of each financial year, the Chief Executive Officer shall prepare an annual report on the activities of Agency. The annual report shall be submitted for tabling in the National Assembly not later than one month after the submission of the Auditor-General’s report. The annual report shall contain: a. the financial statements of the Agency; b. a description of the activities and outcomes of functioning of the Agency; and c. any other information that the may consider relevant. | An annual report allows the National Assembly to assess whether the Agency has used its funds and resources efficiently. |
Clause 20 Bank account | The Chief Executive Officer may in accordance with the law relating to the management of public finance, open bank accounts on behalf of the Agency and shall, as the accounting officer, be responsible for the proper management of the finances of the Agency. | This proposal seeks to align the Bill to be consistent with the provisions of the Public Finance Management Act, 2012. Secondly, the bank account contains the Agency’s funds which will be used to fund its activities. |
PART IV — THE ESTABLISHMENT AND ADMINISTRATION OF THE COMPREHENSIVE INTEGRATED HEALTH INFORMATION SYSTEM |
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Clause 21 Establishment of an integrated health information system | There is established a system to be known as the comprehensive integrated health information system which shall be administered by the Agency. The Agency shall, in consultation with the Cabinet Secretary, establish a framework for administration and management of the system and shall ensure the maintenance of the integrity and security of the system. The system shall operate as a point of collection, collation, analysis, reporting, storage, usage, sharing, retrieval or archival of data related to the state of physical or mental health of the data subject and includes records regarding the past, present or future state of the health, data collected in the course of registration for, or provision of health services, or data which associates the data subject to the provision of specific health services. | The system provides health care facilities with access to a patient’s comprehensive medical history, past diagnoses, treatments and test results. This information aids in making more informed and timely medical decisions. |
Clause 23 Objectives of the system | The main objectives of the system shall be to: a. facilitate people-centred quality health service delivery; b. facilitate data collection and reporting at all levels; c. enable secure health data sharing to ensure timely and informed interfacility health service delivery; d. facilitate data processing and use for informed decision-making at all levels, including: i. at individual patient level; ii. for public health purposes; and iii. for resource allocation and management in the health sector; e. safeguard the privacy, confidentiality, and security of health data for information sharing and use; f. serve the health sector and facilitate in a progressive and equitable manner realisation of universal health coverage, to achieve the highest attainable standard of health; and g. ensure standardisation of health data management. | Well-defined objectives lead to improved patient care by facilitating the seamless flow of information among health care providers. This results in better decision-making, more accurate diagnoses and timely interventions. |
Clause 24 Technical aspect of the system | The Agency shall adopt relevant internationally accepted standards, procedures, technical details, best practices and formalities for effective implementation of the system. The processes and technical aspects of the system shall be guided by the following principles: a. confidentiality, security and privacy; b. scalability and interoperability; c. accuracy, responsiveness and reliability; d. efficiency and effectiveness; e. redundancy; f. transparency; g. simplicity and accessibility; and h. consistency in use. | Implementing international standards lead to cost savings by reducing the complexity of system integration. When the system components adhere to the same standards, it becomes easier to connect and maintain, ultimately reducing implementation and maintenance costs. |
PART V — HEALTH DATA GOVERNANCE |
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Clause 25 Classification of health data | For the purposes of this Act, health data shall be classified into the following categories: a. sensitive personal level health data; b. administrative data; c. aggregate health data; d. medical equipment data; and e. research for health data. | Health data often contains sensitive and confidential information about the medical conditions and treatments of patients. Classification of health data ensures that only authorized personnel can access the sensitive information. This protects the privacy rights of the patients. |
Clause 26 Governing principles | Health data shall be governed by the following principles: a. improvement of client health, safeguard of individuals and communities against harm and violations; b. data security throughout the entire data life-cycle; c. equity and accountability; d. privacy and confidentiality; and e. accuracy and reliability. | Governing principles guide the implementation of robust security measures to protect health data from unauthorized access. This helps health care providers establish safeguards to prevent data breaches and maintain data integrity. Secondly, governing principles promote transparency in data handling practices. This allows patients to understand how their personal health data is used and shared. |
Clause 28 Health data custodian | The Agency shall be the custodian for all health data in Kenya. | Being a custodian of all health data means having a responsibility to safeguard the privacy and data protection rights of data subjects. This involves ensuring that personal health data is collected, processed, stored and used in a manner prescribed by the Data Protection Act. |
Clause 29 Health data use | The Cabinet Secretary shall ensure that health data is used for public good. The Agency shall provide health data to the Cabinet Secretary for relevant action. | We propose that the term “public good” is defined in clause 2 of the Bill. This proposal ensures that there are no differing interpretations as to what constitutes a “public good”. |
PART VI — CONFIDENTIALITY, PRIVACY AND SECURITY OF DATA |
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Clause 30 Security, privacy and disclosure of data in the system | The Cabinet Secretary shall be responsible for the confidentiality, privacy and security of all sensitive personal data held in the system. Sensitive personal data held in the system shall not be disclosed to a third party unless: a. the data subject is unable to give informed consent for the disclosure and such consent is given by a person authorised by the data subject in writing to grant consent; b. the disclosure has been authorised by the implementation of written law or the enforcement of a court order; c. a health service without informed consent as authorised by written law or court order is being provided; d. the data subject is being treated in an emergency situation; e. failure to treat the data subject, or a group of people which includes the data subject, would result in a serious risk to public health; or f. a delay in providing a health service to the data subject may result in death or irreversible damage to the health of the data subject and the data subject has not expressly, by implication or by conduct refused that service. The Cabinet Secretary shall be responsible for the privacy of the data held in the system during all the data life cycle stages. Where the data held in the system data is intended to be used for research and planning, the Cabinet Secretary shall be the data controller for the purposes of section 53 of the Data Protection Act. The Cabinet Secretary shall establish the security measures in the system to protect sensitive personal data including: a. personalised authentication and log-in credentials; b. role based user rights; c. audit trails for all activities within the system; d. digital and physical security of the system; and e. an encrypted backup that is subject to the security measures herein. | The clause seeks to provide the limited instances in which sensitive personal data may be disclosed to a third party. Further, the third party must comply with the Bill and Data Protection Act when handling the sensitive personal data of a data subject. |
Clause 31 Retention and disposal of data in the system | Data held in the system shall be maintained for a minimum period of twenty years. Data held in the system may be maintained for a period exceeding that specified in subsection (1) where: a. it is required or authorised by law; b. it is authorised by the data subject; or c. for historical, statistical or research purposes. Where the period for the maintenance of the data held in the system is not extended under subsection (2), the data shall be secured by de-identification, anonymization, pseudo-anonymization, archiving or establishing such technical and organisational security measures as the Cabinet Secretary may determine to be necessary. | This is a good proposal as the clause has provided for a prescribed period for retaining personal health data before disposal. Retaining data for an extended period poses greater risks (For example, unauthorized access, cybersecurity threats, data breaches etc.). Disposing data that’s no longer needed upon lapse of the prescribed retention period reduces these risks and protects sensitive information. |
Clause 32 Establishment of health data banks | The Cabinet Secretary shall: a. establish a national health data bank and designate county health data banks; b. store the health data submitted to the system in the national health data bank; and c. establish seamless integration and interoperability of the national health data bank with other relevant databases. The County Executive Committee member shall: a. establish county health data banks; b. store the health data submitted to the system in the county health data bank; and c. establish seamless integration and interoperability of the county health data bank with other relevant databases and data banks. Health information databases and data banks referred to in subsections (1) and (2) shall be established at the different levels of healthcare delivery specified under section 25 of the Health Act, 2017. A data controller shall transmit health data containing sensitive personal data to the national health information data bank and county health information data bank in a secure and encrypted form. A data controller shall maintain records of the health data containing sensitive personal data transmitted to the national health information data bank and county health information data bank under subsection (4). | A health data bank contains comprehensive health records of a patient. Access to a patient's complete medical history helps avoid unnecessary duplicate tests and procedures, reducing healthcare costs and minimizing patient inconvenience. For sub-clause (4), storing data in an encrypted form is a good proposal. Encryption ensures that only authorized persons with the proper decryption key or password can access the encrypted data. It protects sensitive data from unauthorized access. |
Clause 33 Use of sensitive personal data | The health data that is contained in a health data bank shall be applied to: a. identify a person who needs or is receiving health services; b. provide health services to, or facilitate the care of or treatment of, a person; c. identify a health service provider who is providing a health service; d. identify a person offering health insurance; e. assess and address public health needs; f. conduct disease surveillance, research and innovation; g. engage in health system planning, management, evaluation or improvement, including health service development, management, delivery, monitoring and evaluation including surveys; h. assess the safety and effectiveness of health services; and i. continuous enhancement of the system. | For the heading of this clause, we propose changing it to “Use of health data”. The rationale for this proposal is that: a. the term “sensitive personal data” has not been defined in the Bill; and b. the term “health data” has been defined in clause 2 of the Bill. To streamline the Bill and enhance uniformity, we propose the deletion of the words “sensitive personal data” throughout the Bill and replacing it with the words “health data”. |
Clause 36 Disclosure of sensitive personal data of deceased persons | A data controller may disclose sensitive personal data about a person who is deceased or is reasonably suspected to be deceased when: a. identifying the person; b. informing a person to whom it is reasonable to inform in the circumstances of; or c. investigating the cause of death. A request under subsection (1) shall be made as provided under the relevant law. | This clause provides the limited instances in which the health data of a deceased person may be disclosed to a third party. |
Clause 37 Consent | A healthcare provider shall ensure that he or she has obtained consent to process sensitive personal data. Subsection (1) shall not apply where a health service is being provided: a. for public health in accordance with the Public Health Act; and b. in compliance with any other statutory requirements. When processing personal data, a healthcare provider shall: a. ensure confidentiality of the information of the client; b. provide prompt and accurate data necessary for treatment of the patient; c. comply with the duty to notify the data subject in accordance with the Data Protection Act. A data subject who has issued a consent to the use or disclosure of personal data may withdraw their consent at any time by notifying the health care provider. | This clause ensures compliance with the provisions of the Data Protection Act where the data subject’s express consent is required before his/her health data can be processed. |
Clause 38 Processing of personal data relating to a minor or a person who does not have capacity | Where a data subject is a minor or for any other reason does not have the capacity to issue informed written consent, the parent, an appointed guardian or next friend of the patient shall, for purposes of subsection (1), act on behalf of, and in the best interest of, the patient in accordance with the law. | This is a good proposal as children and people of unsound mind lack the legal capacity to understand the implications of processing their health data. Secondly, we propose the deletion of the words “for purposes of subsection (1)” as the clause has only one sub-clause. |
Clause 39 Duty to protect sensitive personal data | A data controller shall protect sensitive personal data and adopt reasonable administrative, technical and physical safeguards to ensure the privacy, confidentiality, security, accuracy and integrity of the date. A data controller shall establish controls that govern persons who may use sensitive personal data and such data cannot be used unless: a. the identity of the person seeking to use the information is verified; b. the data processor is authorized to use it, and c. the proposed use is authorised under this Act. | Safeguards put in place by the health data controller prevent data breaches, cyberattack threats and unauthorized persons from accessing the personal health data of data subjects. For sub-clause (1), we propose the deletion of the word “date” and replacing it with the word “data”. This proposal seeks to correct the spelling error present in the sub-clause. |
Clause 40 Disposal of health information | The Cabinet Secretary shall develop regulations for the disposal of sensitive personal data. | We propose the addition of the missing sub-clauses in this clause. This proposal will enhance clarity and completeness in this clause. |
Clause 41 Breach of sensitive personal data | In relation to aggregate data, medical equipment data, research for health data, a person commits an offence if that person: a. tampers with the data; b. abuses a privilege; c. discloses inauthentic access to the data; d. improperly disposes of unnecessary but sensitive data; e. loses data; f. steals data; or g. unintentionally shares sensitive personal data to an unauthorised party. A person who commits an offence under subsection (1) shall be liable, on conviction, to a fine not exceeding five hundred thousand shillings or to imprisonment for a term not exceeding fifteen years or to both. Where a person commits an offence under subsection (1) with respect to sensitive personal data, that person shall be liable, on conviction, to the penalties under section 73 of the Data Protection Act. | This clause acts as a deterrence in ensuring that a person complies with the provisions of this Bill. |
Clause 42 Health Data Portability | Subject to this Act, a person has a right, on request, to examine and receive a copy of his or her personal health information maintained by a data controller. For purposes of subsection (1), to receive a copy of their personal health information, a person must make a written request to the health facility or the health information bank. The health data controller shall comply with the Data Protection Act Section 38 and enable access and portability of personal health record through technology enabled mechanisms inluding but not limited to patient portal. | For sub-clause (2), we propose that a template of the request form is included in the Schedule of this Bill. A template provides a standard format that is easy to understand and use. Further, the use of a template enhances uniformity. |
Clause 43 Refusal to grant access to sensitive personal data | A health data bank may refuse to grant access to a third party all or part of a person’s sensitive data health information if it is reasonable to believe that: a. access is restricted by a court process, order or judgement; b. another law prohibits disclosure; c. the information was collected or created in the course of an inspection, investigation or similar procedure not yet concluded; d. access may lead to the identification of a person who provided information in the record to the custodian in circumstances in which confidentiality was expected; and e. access may result in the release of another person’s personal health data. | This clause protects the data subject’s privacy rights enshrined in Article 31 of the Constitution as it prevents unauthorized access of the data subject’s health data. |
Clause 45 Right to rectification erasure | A health information bank or a health provider may, upon request by the data subject: a. rectify, without undue delay, personal data in its possession or under its control that is inaccurate, outdated, incomplete or misleading; or b. erase or destroy, without undue delay, personal data that the health information is no longer authorised to retain, irrelevant, excessive, or obtained unlawfully. | We propose that a template of the request form is included in the Schedule of the Bill. A template provides a standard format that is easy to understand and use. Further, the use of a template enhances uniformity. |
PART VII — E-HEALTH SERVICE DELIVERY |
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Clause 46 e-Health as a mode of health service delivery | e-Health shall be a recognized model of health service. e-Health Services are complementary to existing healthcare service delivery modalities. | e-health harnesses the power of information technology to enhance the efficiency, accessibility and quality of health care services. This has led to improved access to health care as e-health can bridge geographical gaps and provide health care services to patients in remote areas. This is a good proposal as Parliament has started incorporating e-Health in recent Bills that have been tabled for discussion. For example, the Cancer Prevention and Control (Amendment) Bill 2022 seeks to introduce the use of e-Health in cancer treatment. |
Clause 47 Provision of e-Health services | The e- Health service shall be provided through: a. telemedicine; b. electronic health records; c. m-health; d. e-learning; e. telehealth; and f. any other recognized e-health service. An entity providing e-health services shall be: a. a health care provider holding a valid licence issued by a relevant regulatory body; b. a healthcare provider holding a valid licence from an equivalent regulatory authority outside Kenya but shall be recognized by the local regulatory authority; c. a health facility licenced to offer e-Health services by the relevant regulatory body; d. for foreign facilities, be licenced by an equivalent regulatory authority recognized in Kenya. The Cabinet Secretary shall develop standards and guidelines for the e-Health platform. | The clause seeks to provide the scope of what e-Health services constitute. This will allow for various e-Health services to be governed by this Bill. For sub-clause (2), we propose that a non-health care provider is allowed to develop an e-Health platform. If an e-Health platform is developed by a non-health care provider, we propose that the patient pays the health care provider for services provided while the health care provider will be paying the developer of the e-Health platform for linking the patient to the health care provider. This will allow the developer to be compensated for linking the patient to the health care provider. This approach will be similar to mobile applications like Uber and Bolt. |
Clause 48 Principles and objectives of e-Health | The e-Health service shall be an integral part of health service delivery to benefit people in a manner that is ethical, safe, secure, reliable, equitable and sustainable. The objectives of E-Health shall include: a. to promote patient-centred health care services; b. to ensure equitable access to quality health care services using Information and Communication Technology; c. to promote the integration of e-Health into the healthcare system; d. to facilitate the integration of e-Health solutions; e. to promote the use of e-Health solutions. | E-Health has rapidly grown in Kenya due to an increase in the number of mobile phone users. Examples of common e-Health platforms in Kenya are MyDawa, mHealth Kenya, Health E Net, MedAfrica, Access Afya, Nyumbani Medics, Medbit Kenya and Xelpha Health. There is therefore need to regulate this emerging and constantly evolving sector. Secondly, e-Health reduces health care costs by eliminating the need for physical paperwork, minimizing errors and optimizing resource allocation. Telemedicine also reduced travel expenses for patients seeking health care. Thirdly, e-Health services provide convenient and timely access to health care consultations, reducing wait times and allowing patients to receive health care from the comfort of their homes. |
PART VIII — E-WASTE MANAGEMENT |
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Clause 51 E-waste management | The Cabinet Secretary shall: a. in consultation with county governments, and relevant lead agencies, develop guidelines for the safe handling and disposal of all health sector related e-waste material; and b. in consultation with relevant stakeholders, develop an e-waste management system for the health sector. The e-waste management system in subsection (1) above, shall: a. comprise an appropriate mechanism for segregation of e-waste at source, collection, transportation and processing; b. promote reuse and lifetime extension; c. promote activities aimed at resource recovery and recycling of e-waste materials into useful products; d. embrace the best available technologies and practices in e-waste management; and e. promote sustainable models for e-waste management through public-private partnerships. | E-waste encompasses waste resulting from electrical and electronic equipment. This poses unique challenges due to its toxic components and the potential environmental and health hazards associated with improper disposal. A comprehensive e-waste management system is essential to mitigate these risks and harness the economic and environmental benefits of recycling and responsible disposal. |
PART IX – HEALTH TOURISM |
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Clause 52 Development of guidelines on health tourism | The Cabinet Secretary shall take all necessary measures to safeguard the transfer of a client’s medical records to and from facilities outside Kenya. A data controller who is a custodian of biological specimens, health images, human tissues and organs of a Kenyan citizen and is transferring these outside Kenya shall: a. ensure confidentiality of personal health information; b. provide a report to the Director-General for Health stating the findings; c. not share the health information without notifying the Cabinet Secretary; and d. seek guidance from the Cabinet Secretary in the manner the health information shall be stored, processed and destroyed. | Health tourism guidelines aim to maintain or enhance the quality of health care offered to patients by health care providers. By setting standards, they encourage health care providers to deliver services that meet or exceed international standards. |
PART X — MISCELLANEOUS PROVISIONS |
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Clause 54 Protection from liability | No matter or thing done by the Board, chairperson, any Board member, or any officer, employee or agent of the Agency shall, if the matter or thing is done in good faith and for the purposes of executing any provisions of this Act, render the Board, Chairperson, Board member, or any officer, employee or agent of the Authority or any person acting under the direction of those persons personally liable for any action, claim or demand arising from the same. | This means that a member of the Board or Agency can be personally liable for anything not done in good faith. |
Clause 55 Oath of office | Members of the Board shall on appointment, subscribe to an oath of office. | An oath of office is a legal and moral commitment to uphold the duties and responsibilities of the position. It demonstrates a person’s dedication to fulfilling their role ethically and responsibly. |
Clause 56 Conflict of interest | The Chairperson or a member of the Board, who has a direct or indirect personal interest in a matter being considered or to be considered by the Board, shall as soon as reasonably practicable after the relevant facts concerning the matter have come to their knowledge, disclose the nature of such interest. A disclosure of interest made under subsection (1) shall be recorded in the minutes of the meeting and the chairperson or member shall not take part in the consideration or discussion on or vote during any deliberations on the matter. A person who fails to make the requisite disclosure under this section commits an offence. A member of the Board shall recuse themselves from proceedings before the Board in which they have apparent or perceived conflict of interest. | This is a good proposal. A member that doesn’t have a conflict of interest can make decisions that are in the best interests of the Board. Further, this ensures fairness and objectivity as the member is not influenced by personal gain or biases. |
Clause 57 Confidentiality | A member of the Board or staff of the Agency may not without the consent in writing given by, or on behalf of, the Board, publish or disclose to any person otherwise than in the course of the person’s duties the contents of any document, communication, or information which relates to, and which has come to the person’s knowledge in the course of the person’s duties under this Act. The limitation on disclosure referred to under subsection (1) shall not be construed to prevent the disclosure of criminal activity by a member of the Board or staff of the Agency. | This clause ensures that confidential information is not disclosed to unauthorized persons. |
Clause 59 Offences | A person who: a. obstructs, hinders or threatens a member, an officer, employee or agent of the Board acting under this Act or disregards an order of Board; b. submits false or misleading information to the Board; or c. makes a false representation to, or knowingly misleads a member, an officer, employee or agent of Board or acting under this Act, commits an offence and is liable, on conviction, to a fine of not less than two hundred thousand shillings or to imprisonment for a term of not less than one year, or to both. Any person who violates or fails to comply with any provision of this Act for which no other penalty is provided, commits an offence, and is liable on conviction to a fine not exceeding Kenya shillings two hundred and fifty thousand or imprisonment for a term not exceeding six months, or both. | This clause serves as a deterrent by discouraging individuals from violating the provisions of this Bill. The threat of punishment can dissuade people from committing these offences. |
Clause 61 Compliance to the Data Protection Act | Any person processing personal data under this Act shall comply with the Data Protection Act. | This is a good proposal as it seeks to align the Bill to be consistent with the provisions of the Data Protection Act. Further, this proposal ensures that a conflict of laws does not arise in the future between the two statutes. |