Court blocks Rology operations over health data compliance failures

Rology Medical Kenya Limited has suffered a major setback after the High Court ordered the immediate suspension of its operations in Kenya until it fully complies with the country's digital health and data protection laws.

In a landmark judgment delivered by Justice Patricia Mande Nyaudi at the Milimani Constitutional and Human Rights Division, the court directed the government and health regulators to halt the firm's activities and revoke any approvals relating to the handling of patients' digital health records.

"The operations of the 6th Respondent (Rology Medical Kenya) within the Republic of Kenya are hereby suspended forthwith until such time as they are duly registered and compliant with the provisions of the Data Protection Act, the Digital Health Act and the regulations thereunder, including the Digital Health (Data Exchange Component) Regulations 2025," Justice Nyaudi ordered.

The judge further issued an order compelling the Ministry of Health and the Kenya Medical Practitioners and Dentists Council (KMPDC) to withdraw any licences or authorisations granted to the company.

"An Order of Mandamus is hereby issued directing the 1st and 2nd respondents to forthwith cancel any licences, approvals, or authorisations issued to the 6th respondent in respect of the administration, handling, storage, or processing of patients' portable personal health records and data on its digital platform and/or any associated platforms," the court ruled.

The orders are to be served upon Health Cabinet Secretary Aden Duale, the Digital Health Agency and the Office of the Data Protection Commissioner.

The decision comes following a case filed by Conrad Law Advocates LLP on behalf of officials of the Kenya Association of Radiologists led by Dr Gladys Mwango, Dr Brian Bwombuna, Dr Felister Wangari and Dr Leonard Gikera, who challenged the legality of Rology's operations in Kenya.

According to court documents, the petitioners argued that Rology, a local affiliate of an Egyptian-based teleradiology company, was operating an artificial intelligence-assisted radiology platform without adequate regulatory oversight and in a manner that exposed sensitive patient information to unlawful processing and transfer.

In its judgment, the court found that the company's continued administration of patients' portable personal health records could not proceed outside the framework established under Kenya's digital health and data protection regime.

The petitioners had accused the firm of exporting radiology images outside Kenya without patient consent and facilitating the transfer of highly sensitive medical data to foreign entities.

Court records show the petitioners alleged that the platform enabled healthcare providers to upload patients' data, images and medical histories onto its system, raising concerns over privacy, informed consent and accountability.

The association further argued that patients faced significant risks because the company allegedly disclaimed responsibility for the accuracy of medical reports generated through its platform.

The petitioners maintained that the operations violated constitutional rights, including the right to privacy under Article 31, consumer protection rights and the right to the highest attainable standard of health.

Rology had opposed the petition, arguing that it was a duly incorporated Kenyan company providing tele-radiology services to address shortages of radiologists and improve access to healthcare.

The company told the court that its platform merely facilitated the secure transmission of medical images to qualified radiologists and that reports were subsequently reviewed by licensed Kenyan radiologists before release to hospitals.

Rology also argued that the system had served more than 60,000 patients and supported dozens of public health facilities across the country.

However, the court ultimately sided with the petitioners and granted orders suspending the firm's operations until it complies with the applicable legal and regulatory framework.

Justice Nyaudi also awarded costs of the petition against the Kenya Medical Practitioners and Dentists Council and Rology Medical Kenya Limited.