NAIROBI, Kenya, June 15 – The High Court has suspended the operations of health technology firm Rology Medical Kenya pending compliance with medical licensing, data protection and digital health regulations.
Justice Patricia Nyaundi Mande ordered the immediate suspension, citing risks to patient rights and gaps in regulatory oversight.
The ruling stems from a petition filed by officials of the Kenya Association of Radiologists (KAR), who challenged the legality of the company’s AI-assisted teleradiology services and the transfer of patient medical data through its platform.
The court found that the Kenya Medical Practitioners and Dentists Council (KMPDC) had failed to adequately regulate the company despite its provision of radiology-related services to thousands of patients.
The judgment marks a key legal test for Kenya’s emerging digital health sector, which has attracted growing investment as healthcare providers increasingly adopt telemedicine, remote diagnostics and digital patient management systems.
According to court documents, Rology Medical Kenya said it had served more than 60,000 patients and supported over 40 public health facilities through a platform that connects hospitals with radiologists globally before reports are reviewed and validated by licensed Kenyan practitioners.The company argued that the platform helps address shortages of radiologists, lowers healthcare costs and expands access to specialised medical services, particularly in underserved areas.However, the petitioners argued that the platform was operating without sufficient regulatory approvals and exposed patients to privacy risks through the handling and transfer of sensitive medical information.The court agreed that the absence of clear registration and oversight mechanisms raised concerns relating to healthcare quality, consumer protection and patient privacy.Justice Mande noted that registration of medical service providers is not merely a procedural requirement but a safeguard intended to ensure accountability, professional competence and public protection.”When an entity providing radiology services engages with tens of thousands of patients, the question of regulatory compliance is not abstract,” the judge said.”It bears directly on patient safety, professional oversight, and the constitutional and statutory obligations designed to protect the public.”The court further held that regulators could not rely on delays in implementing digital health regulations to justify a lack of oversight.While the judgment does not outlaw digital health services, it reinforces the requirement that technology-driven healthcare providers comply with existing medical licensing and data protection laws before offering services to patients.The court ordered the suspension of Rology Medical Kenya’s operations until it complies with the Kenya Medical Practitioners and Dentists Act, the Data Protection Act, the Digital Health Act and related regulations.It also directed the Ministry of Health and KMPDC to cancel any licences, approvals or authorisations issued to the company relating to the administration and processing of patients’ health records on its platform.The petitioners were awarded costs, payable by KMPDC and Rology Medical Kenya.
