The High Court has ordered the suspension of operations of a digital radiology firm that connected Kenyan hospitals with radiologists across the globe, citing concerns over the use of artificial intelligence and telemedicine services without adequate regulatory oversight.
In a landmark ruling that could influence the future regulation of AI-powered healthcare technologies and cross-border medical services in Kenya, the court found that government regulators had failed to ensure that Rology Medical Kenya Ltd complied with licensing requirements and data protection laws.
The company had previously stated that it had served more than 60,000 patients and supported radiology services in 40 public health facilities across the country.
The court held that existing oversight mechanisms contained significant gaps that could expose patients to risks relating to privacy, safety and constitutional rights. It further ruled that courts have the authority to intervene where emerging digital health technologies pose potential harm, even before any actual injury is demonstrated.
As a result, the judge directed the company to immediately stop its operations until it fully complies with the provisions of the Kenya Medical Practitioners and Dentists Act, the Data Protection Act, the Digital Health Act and other regulations governing digital healthcare services.
The ruling also instructed the Ministry of Health and the Kenya Medical Practitioners and Dentists Council to revoke any licences, approvals or authorisations granted to the company concerning the collection, storage and processing of patients’ medical records through its digital platforms.
The case was brought by four officials from the Kenya Association of Radiologists, who argued that the company’s operations exposed patients to privacy risks, weakened professional oversight and created an uneven playing field for locally licensed radiologists who operate under strict regulatory standards.
At the centre of the dispute was whether the company, described in court documents as the Kenyan affiliate of an Egyptian-founded teleradiology platform, had been operating lawfully while facilitating the interpretation of medical scans by radiologists located outside Kenya.
The petitioners claimed that patients’ radiological images and medical histories were being transmitted abroad without informed consent and without sufficient disclosure regarding the identities, qualifications and locations of the professionals preparing diagnostic reports. They argued that such practices infringed constitutional protections relating to privacy, consumer rights, fair labour practices and access to quality healthcare.
Rology rejected the allegations.
In documents submitted to the court, the company maintained that its platform helps address shortages of radiologists by connecting healthcare facilities with qualified specialists worldwide. It further stated that all reports generated through its system undergo review and validation by licensed Kenyan radiologists before being released to hospitals.
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The firm also disputed claims that artificial intelligence was responsible for generating diagnoses. According to the company, its technology functions primarily as a matching platform that links uploaded medical images with qualified radiologists across its global network, while Kenyan specialists retain responsibility for reviewing and approving reports before they are formally issued.
In its decision, the court emphasised that the issues raised extended beyond routine administrative matters that could be handled solely by regulators such as the Office of the Data Protection Commissioner. The judge observed that the petition raised fundamental constitutional questions touching on privacy, patient safety and accountability in the use of emerging healthcare technologies, making judicial intervention necessary.
