INTRODUCTION
1. The Petitioners present the Petition dated 18 th July 2024 and seek the following orders-
A. A DECLARATION that failure by the 1st, 2nd and 3rd Respondent to maintain a consent management register with respect to patients’ health data is a violation of the right to privacy as guaranteed under Article 31 of the Constitution of Kenya.
B. A DECLARATION that sharing of patients’ health data by healthcare providers on the 6th Respondent’s platform is a violation of the patient’s privacy rights as guaranteed under Article 31 of the Constitution of Kenya.
C. A DECLARATION that the administration of patients’ portable personal health records and data by the 6th Respondent within their platform before the establishment, ratification and implementation of guidelines and regulations anticipated under the Digital Health Act, the Data Protection Act and the prevailing regulatory provisions is unlawful.
D. An ORDER OF MANDAMUS issued to the 1 st and 2 nd Respondents to cancel the licenses/approvals issued to the 6 th Respondent with respect to the administration of patients’ portable personal health records and data within the 6th Respondent's digital platform and/or associated platforms.
E. AN ORDER OF PROHIBITION to restrain the 6 th Respondents from administering patients' portable personal health records and data within their platforms within the Republic of Kenya.
F. AN ORDER OF PROHIBITION be issued against healthcare providers within the Republic of Kenya from sharing patients’ portable personal health records and data
G. Costs to this Petition
SUMMARY OF THE PETITIONER’S CASE
1. The Petition before the Court is instituted by four medical practitioners—Dr. Gladys Mwango, Dr. Brian Bwombuna, Dr. Felister Wangari and Dr. Leonard Gikera—who sue as officials of the Kenya Association of Radiologists (KAR). They aver that they bring the Petition both in their own interest and in the public interest, asserting that the matters raised touch on the constitutional rights of millions of Kenyans. The Petitioners describe KAR as the national professional society for radiologists, mandated to safeguard standards in medical imaging.
2. The Petition is directed against six Respondents, including the Cabinet Secretary for Health, the Kenya Medical Practitioners and Dentists Council (KMPDC), the Digital Health Agency (DHA), the Data Protection Commissioner, the Attorney General, and Rology Medical Kenya Ltd—the latter being described as the local affiliate of “Rology Inc”, a foreign AIassisted teleradiology platform headquartered in Egypt. The Petitioners contend that the 6th Respondent purports to offer radiology services in Kenya without the requisite regulatory approvals.
3. The Petitioners assert that radiology is a highly specialised medical discipline whose diagnostic and interventional procedures carry significant medicolegal implications. They state that only trained and licensed radiologists may lawfully interpret medical images. They allege, however, that the 6th Respondent has been “exporting radiology images out of Kenya for reporting by foreigners and/or unknown persons”, without patient consent and without disclosure of the identities or qualifications of the persons generating the reports.
4. It is the Petitioners’ case that the 6th Respondent operates an artificialintelligenceassisted teleradiology platform that has not been validated, peerreviewed or certified in accordance with Kenyan law. They further allege that the platform facilitates unlawful data sharing, including the transfer of sensitive medical images and patient histories to foreign entities, contrary to the Data Protection Act and the Digital Health Act. They cite contractual clauses requiring hospitals to upload “all data, images and medical history” into the Rology application, which they say violates statutory safeguards for personal health information.
5. The Petitioners contend that the impugned platform exposes patients to grave risks, including misdiagnosis, loss of privacy, and lack of recourse in the event of malpractice. They highlight disclaimers in Rology’s service agreements stating that the company “shall not be liable for the correctness or accuracy of the information transferred” and does not guarantee the accuracy or completeness of its reports. They argue that such disclaimers leave patients without protection and unfairly shift liability to local hospitals.
6. The Petitioners further allege that the 6th Respondent’s operations undermine fair labour practices by creating a “gigeconomy akin to hawking and touting of radiological services”, thereby disadvantaging licensed radiologists who remain subject to strict regulatory oversight. They assert that this constitutes discrimination contrary to Article 27 of the Constitution.
7. The Petitioners accuse the 1st, 2nd and 3rd Respondents of regulatory inertia and dereliction of duty. They aver that, despite the commencement of the Digital Health Act on 2 November 2023, the Respondents have failed to establish the frameworks, guidelines, and consent management systems required to govern digital health services. They state that the Respondents have allowed unlicensed entities to operate unchecked, thereby violating Articles 21, 31, 43 and other constitutional provisions.
8. The Petitioners also fault the Data Protection Commissioner for failing to enforce statutory safeguards relating to the processing, transfer and storage of sensitive health data. They assert that the Commissioner has not acted on complaints lodged by KAR regarding the 6th Respondent’s alleged breaches of data protection law.
9. The Petition invokes a wide range of constitutional and statutory provisions, including Articles 19, 20, 21, 22, 23, 24, 27, 28, 31, 35, 41 and 43 of the Constitution; the Health Act; the Digital Health Act; the Data Protection Act; and the Consumer Protection Act. The Petitioners argue that the Respondents’ acts and omissions amount to violations of the rights to privacy, dignity, fair labour practices, consumer protection, and the highest attainable standard of health.
10. The Petitioners pray for declarations that the Respondents’ failure to maintain a consentmanagement register violates Article 31; that the sharing of patient data on the 6th Respondent’s platform is unconstitutional; and that the administration of patient health records by the 6th Respondent prior to the establishment of statutory guidelines is unlawful. They seek further orders restraining the Respondents from permitting unregulated digital health services and compelling compliance with the Digital Health Act and the Data Protection Act.
11. The Petition is supported by the Affidavit of Dr Gladys Mwango, the 1st Petitioner and Chair of the Kenya Association of Radiologists. She avers that the 6th Respondent, Rology Medical Kenya Ltd, offers unregulated and unlicensed AI ‑ assisted teleradiology services in Kenya. She states that the entity has been “exporting radiology images out of Kenya for reporting by foreigners and/or unknown persons” without patient consent, using an unvalidated platform and undisclosed radiologists.
12. She further depones that the 1st–5th Respondents have failed to regulate digital health systems, safeguard sensitive medical data, or act on complaints, thereby exposing patients to privacy breaches, misdiagnosis risks, and discriminatory practices.
SUMMARY OF THE 2 ND RESPONDENT’S CASE
13. The CEO of the 2 nd respondent has sworn an affidavit on 3rd June 2025 in opposition to the Petition. He avers that the Petition does not disclose or demonstrate the constitutional provisions alleged to have been violated, infringed, or threatened with violation or infringement. It is conceded that the 2 nd respondent is the agency mandated to regulate the practice of radiology in Kenya. In this regard, it is contended that the 2nd Respondent ensures that radiology practices adhere to ethical and safety guidelines and that practitioners have the necessary qualifications and experience, and that this extends to the practice of tele-radiology in the country.
14. The 2 nd Respondent avers further that regulation of virtual medical service was to fall under the Digital Health Agency but that the parent act, namely the Digital Health Act No. 15 of 2023 was declared unconstitutional by judgment delivered on 12 th July 2024 in Aura v Cabinet Secretary, Ministry of Health & 11 others; Kenya Medical Practitioners & Dentist Council & another (Interested Parties) [2024] KEHC 8255 (KLR)
15. The 2 nd respondent states that it has discharged its responsibility by issuing notice to all health facilities of the compliance requirement under the Data Protection Act, implemented through the office of the Data Protection Commissioner and that the issues raised in the Petition are in the sole mandate of the Data Protection Commissioner, the 4 th Respondent.
SUMMARY OF THE 6 TH RESPONDENT’S CASE
16. The 6 th respondent has filed a Notice of Preliminary Objection dated 25 th July 2024. The 6th Respondent objects to the Petition on grounds that it fails to plead, with the constitutionally required precision, the specific provisions allegedly violated and therefore discloses no justiciable constitutional cause. It is further contended that the issues raised fall within the exclusive statutory mandate of the Data Protection Commissioner under the Data Protection Act, 2019, rendering the Petition premature and offending the doctrines of ripeness, exhaustion, and constitutional avoidance. The 6th Respondent accordingly urges that the Petition be struck out at in limine .
17. In addition to the Preliminary Objection, the 6 th Respondent has filed a replying affidavit sworn on 25 th July 2024 by Judah Mutie Musyoka, a director of the 6th Respondent. He avers that the Petition and Application are misconceived, imprecise, and fail to disclose any constitutional violations with the degree of particularity required. He asserts that the issues raised fall within the exclusive jurisdiction of the Data Protection Commissioner under the Data Protection Act, and that the Digital Health Act, heavily relied upon by the Petitioners, was declared unconstitutional in Aura v Cabinet Secretary, Ministry of Health & 11 others; Kenya Medical Practitioners & Dentist Council & another (Interested Parties) (supra) , rendering it inapplicable.
18. He states that the 6th Respondent is a duly incorporated Kenyan company offering tele ‑ radiology services to enhance access to healthcare, particularly in light of the shortage of radiologists, high costs, and geographical barriers. He explains that the platform matches medical images uploaded by hospitals with qualified radiologists worldwide, whose reports are subsequently reviewed and validated by licensed Kenyan radiologists before release.
19. He denies that the platform uses artificial intelligence to generate diagnoses, stating instead that it merely facilitates secure transmission of images to human radiologists. He further asserts that the images transmitted “are not personal data capable of identifying the patient” and are accessible only to authorized radiology professionals. He adds that the platform has undergone rigorous quality assurance and is FDA ‑ cleared, demonstrating compliance with international standards.
20. The deponent highlights that the platform has served over 60,000 patients, supports 40 public health facilities, and engages numerous radiology professionals in Kenya. He contends that restraining the platform would cause grave harm to patients already onboarded, including potential loss of life due to delayed care. He further argues that the Petitioners’ actions reflect an attempt to “hoard the provision of health services” and resist technological advancement to the detriment of public interest.
21. He concludes that the Petitioners have not demonstrated a prima facie case or any public interest warranting the conservatory orders sought. He asserts that granting the orders would effectively determine the Petition prematurely and create an uncompetitive environment, contrary to societal progress. He therefore urges the Court to dismiss the Application and the Petition with costs.
SUMMARY OF THE PETITIONERS’ SUBMISSIONS
22. The Petitioner’s submissions are dated 5 th June 2025. It is submitted that the Petition is competent and that the Petitioners are entitled to the reliefs sought. It is submitted that, on account of the respondents' laxity, the patients' right to privacy is likely to be violated. Reference is made to the decisions in Kenya Human Rights Commission v Communications Authority of Kenya & 4 others [2018] eKLR and Centre for Human Rights and Democracy & another v the Judges and Magistrates vetting board & 2 others [2012]eKLR.
23. With regard to the Preliminary Objection, the Petitioner filed submissions dated 12 th August 2024.
24. The Petitioners oppose the 6th Respondent’s Preliminary Objection, arguing that it does not raise a pure point of law as required under Mukisa Biscuits Manufacturing Co. Ltd v West End Distributors Ltd [1969] EA 696. It is submitted that the Objection as framed does not raise a pure point of law and it should therefore fail. Refernce is made to the decision in Oraro v Mbaja [2005] eKLR.
25. They submit that the Petition clearly identifies the constitutional provisions allegedly violated as Articles 24, 27, 28, 31, 35, 41, 43 and 46, and sets out the factual matrix with precision in compliance with Rule 10 of the Mutunga Rules. Further, it is submitted that in line with Article 22(3)(b) of the Constitution, the Petition should not be dismissed, and reference is made to the decision in Michael Osundwa Sakwa v Chief Justice and President of the Supreme Court of Kenya & Anor [ 2016] eKLR .
26. They contend that the High Court has jurisdiction under Article 165(3)(b) to determine alleged violations of fundamental rights, and that the Data Protection Commissioner lacks constitutional interpretive authority. They further argue that the doctrines of ripeness, exhaustion and constitutional avoidance do not apply, as the Petition raises issues that can only be adjudicated through a constitutional petition The Petitioners therefore urge the Court to dismiss the Preliminary Objection with costs.
SUMMARY OF THE 2 nd RESPONDENT’S SUBMISSIONS
27. The Submissions of the 2 nd respondent are dated 24 th June 2025. Reference is made to the decisions in Anarita Karimi Njeru vs Republic (Supra) and Mumo Matemu vs Trusted Society of Human Rights Alliance & 5 Others [2013] eKLR on the failure of the Petition to disclose or demonstrate the constitutional provisions alleged to have been violated or infringed upon or threatened with infringement.
28. With regard to the Doctrine of exhaustion, reference is made to the decisions in Geoffrey Muhinja & Anor vs Emmanuel Muguna Henry & 1756 Others [2015] eKLR; Kirima v Solar Panda Company & Anor [2024] KEHC 11499 (KLR); Speaker of the National Assembly v Karume [1992]KECA 42 (KLR)
SUMMARY OF THE 6 TH RESPONDENT’S SUBMISSIONS.
29. The 6 th Respondent has filed two sets of submissions. The first is dated 1 st August 2024, and the rejoinder submissions are dated 29 th September 2025. The issue framed for determination is whether the 6 th Respondent’s Preliminary objection is meritorious. In addition to the celebrated decision in Mukisa Biscuits case ( supra), the 6 th Respondent relies on the decision in Nitin Properties Ltd v Singh Kalsi & Anor [1995] eKLR on the legal threshold for a meritorious preliminary objection.
30. It is further submitted that the Petition has not met the requirement in Anarita case (Supra) and Mumo Matemu case ( Supra). It is submitted that the Petition should therefore be dismissed as was held in Jamlic Muriithi v Law Society Of Kenya & another; Mathew Nyabena & 4 others (Interested Parties) [2021] eKLR.
31. The Petition, it is submitted should be struck out for offending the Doctrine of Exhaustion and reference made to the decisions in Miano & others v Attorney General & others [2021] eKLR; United Millers Limited v Kenya Bureau of Standards, Director, Directorate of Criminal Investigations & 5 others [2021] eKLR; Mwangi & Another v Naivasha County Hotel t/a Sawela Lodges (Petition E003 of 2021) [2022] KEHC 10975 (KLR) (19 July 2022) (Ruling) and Albert Chaurembo Mumba & 7 others (sued on their own behalf and on behalf of predecessors and or successors intitle in their capacities as the Registered Trustees of Kenya Ports Authority Pensions Scheme) v Maurice Munyao & 148 others (suing on their own behalf and on behalf of the Plaintiffs and other Members/Beneficiaries of the Kenya Ports Authority Pensions Scheme) [2019] eKLR
32. In the rejoinder submissions, the 6th Respondent contends that the Petition reiterates that the Petition is fatally defective for want of jurisdiction, precision and procedural propriety It is argued that the Petitioners have adopted “a scattergun approach to constitutional citation… without establishing any clear nexus between specific constitutional provisions and particular factual allegations.”
33. The Respondent reiterated that the true gravamen of the dispute concerns alleged breaches of statutory duties under the Data Protection Act and Digital Health Act, matters that fall within the specialised mandates of the Data Protection Commissioner and the Kenya Medical Practitioners and Dentists Council. The Petition therefore runs afoul of exhaustion, ripeness and constitutional avoidance. It is submitted that the High Court must defer to statutory mechanisms where Parliament has provided an alternative forum, emphasising that “even if all facts pleaded… are accepted as true, they invoke statutory rather than constitutional jurisdiction in the first instance.”
34. The Respondent further submits that its Preliminary Objection raises pure points of law because jurisdiction is determined solely from the pleadings, relying on Kenya Tea Growers Association v AG [2022] KEELRC 4124 (KLR) and Gcaba v Minister for Safety and Security2010 (1) SA 238 (CC) . It rejects the Petitioners’ claim that it introduced new grounds, asserting that describing the Petition as “a civil claim… couched as a constitutional grievance” is merely a legal characterization flowing from the pleaded objection. The Respondent argues that the Petitioners have not demonstrated any exceptional circumstances to bypass the exhaustion doctrine and that permitting the Petition to proceed would undermine the statutory dispute ‑ resolution framework and encourage forum shopping. It therefore urges the Court to uphold the Preliminary Objection and strike out the Petition in limine with costs, submitting that the Petition “remains vague and imprecise… and improperly invokes the original jurisdiction of this Honourable Court.”
ANALYSIS AND DETERMINATION
35. Having considered the pleadings, the submissions of the parties, and the applicable law, I frame the following issues for determination:
1. Whether the Preliminary Objection is meritorious?
2. Whether this Court has jurisdiction, or whether the Petition is barred by the doctrines of exhaustion, ripeness, or constitutional avoidance?
3. Have the Petitioners established violations or threatened violations of constitutional rights?
4. If the answer to (3) is in the affirmative, what remedies are appropriate?
Whether the Preliminary Objection is meritorious?
36. In Independent Electoral & Boundaries Commission v Cheperenger & 2 Others [2015] KESC 2 (KLR ), the Supreme Court articulated the strict parameters governing preliminary objections in Kenya. The Court emphasised that a true preliminary objection serves two important purposes: it shields the objecting party from unnecessary expenditure of time and resources, and it preserves scarce judicial resources for matters that warrant full adjudication. It is not to be wielded as a tactical device to short ‑ circuit a dispute that properly requires resolution on the merits.
37. It is equally well established that a preliminary objection may be raised only on a pure point of law. As the Court stated in Oraro v Mbaja [2005] KEHC 3182 (KLR), a matter cannot qualify as a preliminary objection if it is entangled with contested facts or if its foundation depends on evidence that must be tested through ordinary evidentiary processes. A preliminary objection must stand or fall on the face of the pleadings alone.
38. The Preliminary Objection before this Court is intertwined with several contested factual issues, including whether patient data is exported, whether the platform employs artificial intelligence, whether the images constitute personal data, and whether the Digital Health Act applies to the impugned conduct. These are matters that cannot be resolved without evidence and therefore fall outside the narrow scope of a proper preliminary objection.
39. I therefore find that the Preliminary Objection does not meet the Mukisa Biscuit threshold and must be dismissed.
40. I would add that the 6th Respondent proceeds on the mistaken assumption that the Digital Health Act is suspended. The correct position is that the High Court’s decision in Aura v Cabinet Secretary, Ministry of Health & 11 Others; Kenya Medical Practitioners & Dentists Council & Another (Interested Parties) [2024] KEHC 8255 (KLR) was stayed by the Court of Appeal in Cabinet Secretary, Ministry of Health v Aura & 13 Others [2024] KECA 1195 (KLR). The effect of that stay is that the Digital Health Act remains in force.
Whether this Court has jurisdiction, or whether the Petition is barred by the doctrines of exhaustion, ripeness, or constitutional avoidance?
In Macharia & another v Kenya Commercial Bank Ltd & 2 others [2012] KESC 8 (KLR) the Supreme Court directed thus-
A Court’s jurisdiction flows from either the Constitution or legislation or both. Thus, a Court of law can only exercise jurisdiction as conferred by the constitution or other written law. It cannot arrogate to itself jurisdiction exceeding that which is conferred upon it by law. We agree with counsel for the first and second respondents in his submission that the issue as to whether a Court of law has jurisdiction to entertain a matter before it, is not one of mere procedural technicality; it goes to the very heart of the matter, for without jurisdiction, the Court cannot entertain any proceedings. This Court dealt with the question of jurisdiction extensively in, In the Matter of the Interim Independent Electoral Commission (Applicant), Constitutional Application Number 2 of 2011. Where the Constitution exhaustively provides for the jurisdiction of a Court of law, the Court must operate within the constitutional limits. It cannot expand its jurisdiction through judicial craft or innovation. Nor can Parliament confer jurisdiction upon a Court of law beyond the scope defined by the Constitution. Where the Constitution confers power upon Parliament to set the jurisdiction of a Court of law or tribunal, the legislature would be within its authority to prescribe the jurisdiction of such a court or tribunal by statute law.
41. Article 165(3)(b) vests in the High Court the solemn duty of determining whether fundamental rights have been violated. That jurisdiction, once conferred by the Constitution itself, cannot be taken away by statute, nor diminished by administrative bodies, however eminent. The Petitioners say that, by reason of the omissions and acts of the respondents, there is a real risk that the rights of patients and their own rights may be infringed: the right to privacy under Article 31, the right to fair labour relations under Article 41, the right to health under Article 43(1)(a), and the rights of consumers under Article 46. These are not matters that can be tucked away into the remit of the Data Protection Commissioner or the Medical Practitioners and Dentists Council. They go deeper. They touch the very fabric of constitutional protections.
42. The doctrine of exhaustion holds an honored place in our system. It ensures that, as the Court of Appeal said in Muthinja & Another v Henry & 1756 Others (Supra), parties first pursue the remedies available to them before rushing to court. It is a sensible doctrine, fashioned to prevent the courts from being burdened with matters that can be resolved elsewhere. But, like all good principles, it is not absolute. As was observed in Wahome v Public Health Officers & Technicians Council & Another (Supra) , there are occasions when the doctrine must give way. When the complaint concerns the violation of constitutional rights, when the very legality of State action is called into question, the doors of the High Court cannot be shut. For the Constitution itself commands that they remain open
43. The exceptions were discussed in William Odhiambo Ramogi & 3 others v Attorney General & 4 others; Muslims for Human Rights & 2 others (Interested Parties) [2020] eKLR as follows,
What emerges from our jurisprudence in these cases are at least two principles: while, exceptions to the exhaustion requirement are not clearly delineated, Courts must undertake an extensive analysis of the facts, regulatory scheme involved, the nature of the interests involved – including level of public interest involved and the polycentricity of the issue (and hence the ability of a statutory forum to balance them) to determine whether an exception applies. As the Court of Appeal acknowledged in the Shikara Limited Case (supra), the High Court may, in exceptional circumstances, find that exhaustion requirement would not serve the values enshrined in the Constitution or law and permit the suit to proceed before it. This exception to the exhaustion requirement is particularly likely where a party pleads issues that verge on Constitutional interpretation especially in virgin areas or where an important constitutional value is at stake. See also Moffat Kamau and 9 Others v Aelous (K) Ltd and 9 Others.)
44. In this case, the Petitioners says that their rights and those of patients stand in jeopardy. They speak of threatened violations, not remote or fanciful, but real enough to warrant the Court’s attention. In such circumstances, the doctrines of exhaustion, ripeness, and constitutional avoidance cannot be used as barriers to shut the courthouse door. Where constitutional rights are at stake, and where the ordinary mechanisms offer no timely or adequate remedy, the High Court must step in. I therefore hold that this Petition falls squarely within the recognised exceptions to those doctrines
Have the Petitioners established violations or threatened violations of constitutional rights?
45. The Petition rests on a central contention: that the 2nd Respondent has failed to register the 6th Respondent, and that this omission carries significant implications for the rights of patients and for the Petitioners, who practice in the specialised and highly regulated field of radiology. Registration is not a procedural nicety. It is a statutory safeguard designed to ensure accountability, professional competence, and the protection of those who rely on medical services. Where such a safeguard is not observed, the potential consequences for constitutional rights cannot be dismissed.
46. Notably, the 2nd Respondent offers no substantive response to the allegation that it has failed to register the 6th Respondent. The Petitioners’ inquiry regarding the regulatory status of the 6th Respondent went unanswered. Nor does the 2nd Respondent dispute that the governing statute imposes a mandatory obligation to register all persons providing medical services. It is also uncontested, by both the 2nd and 6th Respondents, that the services offered by the 6th Respondent are radiology ‑ related. Yet the 6th Respondent appears before the Court as a private limited company, without evidence of compliance with the statutory framework governing medical practice. That silence is significant.
47. The 6 th respondent described it services thus-
[11] The 6 th respondent in keeping with every Kenyan’s Constitutional right to access to health care services and the right not to be denied emergency medical treatment has launched a program that allows patients to access radiology services by linking them to qualified professional radiologists world wide through the 6 th respondents platform which services are then supervised and validated by registered and licensed radiologists in Kenya in compliance with existing laws and regulations in the country.
[12] The 6 th respondent’s technological solution involves a patient visiting a hospital/ healthcare facility, which would then create an account for its patient and scan the medical image into the 6 th respondent’s platform, which would them match each case with the most qualified available radiologist who would then arrive at a diagnosis, write the report and send it back to the 6 th respondent which would then engage a qualified and licensed radiologist in Kenya to review and validate the report before formal issuance to the medical service provider ( hospital/ healthcare facility ) to manage the patient’s medical needs.
48. The 6th Respondent further states that, as at the time of filing the Petition, it had served more than 60,000 patients, and it describes the process through which those services are delivered. That figure underscores the magnitude of the operation and the breadth of its reach. It also heightens the constitutional stakes. When an entity providing radiology services engages with tens of thousands of patients, the question of regulatory compliance is not abstract. It bears directly on patient safety, professional oversight, and the constitutional and s
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1. The Petitioners present the Petition dated 18 th July 2024 and seek the following orders-
A. A DECLARATION that failure by the 1st, 2nd and 3rd Respondent to maintain a consent management register with respect to patients’ health data is a violation of the right to privacy as guaranteed under Article 31 of the Constitution of Kenya.
B. A DECLARATION that sharing of patients’ health data by healthcare providers on the 6th Respondent’s platform is a violation of the patient’s privacy rights as guaranteed under Article 31 of the Constitution of Kenya.
C. A DECLARATION that the administration of patients’ portable personal health records and data by the 6th Respondent within their platform before the establishment, ratification and implementation of guidelines and regulations anticipated under the Digital Health Act, the Data Protection Act and the prevailing regulatory provisions is unlawful.
D. An ORDER OF MANDAMUS issued to the 1 st and 2 nd Respondents to cancel the licenses/approvals issued to the 6 th Respondent with respect to the administration of patients’ portable personal health records and data within the 6th Respondent's digital platform and/or associated platforms.
E. AN ORDER OF PROHIBITION to restrain the 6 th Respondents from administering patients' portable personal health records and data within their platforms within the Republic of Kenya.
F. AN ORDER OF PROHIBITION be issued against healthcare providers within the Republic of Kenya from sharing patients’ portable personal health records and data
G. Costs to this Petition
SUMMARY OF THE PETITIONER’S CASE
1. The Petition before the Court is instituted by four medical practitioners—Dr. Gladys Mwango, Dr. Brian Bwombuna, Dr. Felister Wangari and Dr. Leonard Gikera—who sue as officials of the Kenya Association of Radiologists (KAR). They aver that they bring the Petition both in their own interest and in the public interest, asserting that the matters raised touch on the constitutional rights of millions of Kenyans. The Petitioners describe KAR as the national professional society for radiologists, mandated to safeguard standards in medical imaging.
2. The Petition is directed against six Respondents, including the Cabinet Secretary for Health, the Kenya Medical Practitioners and Dentists Council (KMPDC), the Digital Health Agency (DHA), the Data Protection Commissioner, the Attorney General, and Rology Medical Kenya Ltd—the latter being described as the local affiliate of “Rology Inc”, a foreign AIassisted teleradiology platform headquartered in Egypt. The Petitioners contend that the 6th Respondent purports to offer radiology services in Kenya without the requisite regulatory approvals.
3. The Petitioners assert that radiology is a highly specialised medical discipline whose diagnostic and interventional procedures carry significant medicolegal implications. They state that only trained and licensed radiologists may lawfully interpret medical images. They allege, however, that the 6th Respondent has been “exporting radiology images out of Kenya for reporting by foreigners and/or unknown persons”, without patient consent and without disclosure of the identities or qualifications of the persons generating the reports.
4. It is the Petitioners’ case that the 6th Respondent operates an artificialintelligenceassisted teleradiology platform that has not been validated, peerreviewed or certified in accordance with Kenyan law. They further allege that the platform facilitates unlawful data sharing, including the transfer of sensitive medical images and patient histories to foreign entities, contrary to the Data Protection Act and the Digital Health Act. They cite contractual clauses requiring hospitals to upload “all data, images and medical history” into the Rology application, which they say violates statutory safeguards for personal health information.
5. The Petitioners contend that the impugned platform exposes patients to grave risks, including misdiagnosis, loss of privacy, and lack of recourse in the event of malpractice. They highlight disclaimers in Rology’s service agreements stating that the company “shall not be liable for the correctness or accuracy of the information transferred” and does not guarantee the accuracy or completeness of its reports. They argue that such disclaimers leave patients without protection and unfairly shift liability to local hospitals.
6. The Petitioners further allege that the 6th Respondent’s operations undermine fair labour practices by creating a “gigeconomy akin to hawking and touting of radiological services”, thereby disadvantaging licensed radiologists who remain subject to strict regulatory oversight. They assert that this constitutes discrimination contrary to Article 27 of the Constitution.
7. The Petitioners accuse the 1st, 2nd and 3rd Respondents of regulatory inertia and dereliction of duty. They aver that, despite the commencement of the Digital Health Act on 2 November 2023, the Respondents have failed to establish the frameworks, guidelines, and consent management systems required to govern digital health services. They state that the Respondents have allowed unlicensed entities to operate unchecked, thereby violating Articles 21, 31, 43 and other constitutional provisions.
8. The Petitioners also fault the Data Protection Commissioner for failing to enforce statutory safeguards relating to the processing, transfer and storage of sensitive health data. They assert that the Commissioner has not acted on complaints lodged by KAR regarding the 6th Respondent’s alleged breaches of data protection law.
9. The Petition invokes a wide range of constitutional and statutory provisions, including Articles 19, 20, 21, 22, 23, 24, 27, 28, 31, 35, 41 and 43 of the Constitution; the Health Act; the Digital Health Act; the Data Protection Act; and the Consumer Protection Act. The Petitioners argue that the Respondents’ acts and omissions amount to violations of the rights to privacy, dignity, fair labour practices, consumer protection, and the highest attainable standard of health.
10. The Petitioners pray for declarations that the Respondents’ failure to maintain a consentmanagement register violates Article 31; that the sharing of patient data on the 6th Respondent’s platform is unconstitutional; and that the administration of patient health records by the 6th Respondent prior to the establishment of statutory guidelines is unlawful. They seek further orders restraining the Respondents from permitting unregulated digital health services and compelling compliance with the Digital Health Act and the Data Protection Act.
11. The Petition is supported by the Affidavit of Dr Gladys Mwango, the 1st Petitioner and Chair of the Kenya Association of Radiologists. She avers that the 6th Respondent, Rology Medical Kenya Ltd, offers unregulated and unlicensed AI ‑ assisted teleradiology services in Kenya. She states that the entity has been “exporting radiology images out of Kenya for reporting by foreigners and/or unknown persons” without patient consent, using an unvalidated platform and undisclosed radiologists.
12. She further depones that the 1st–5th Respondents have failed to regulate digital health systems, safeguard sensitive medical data, or act on complaints, thereby exposing patients to privacy breaches, misdiagnosis risks, and discriminatory practices.
SUMMARY OF THE 2 ND RESPONDENT’S CASE
13. The CEO of the 2 nd respondent has sworn an affidavit on 3rd June 2025 in opposition to the Petition. He avers that the Petition does not disclose or demonstrate the constitutional provisions alleged to have been violated, infringed, or threatened with violation or infringement. It is conceded that the 2 nd respondent is the agency mandated to regulate the practice of radiology in Kenya. In this regard, it is contended that the 2nd Respondent ensures that radiology practices adhere to ethical and safety guidelines and that practitioners have the necessary qualifications and experience, and that this extends to the practice of tele-radiology in the country.
14. The 2 nd Respondent avers further that regulation of virtual medical service was to fall under the Digital Health Agency but that the parent act, namely the Digital Health Act No. 15 of 2023 was declared unconstitutional by judgment delivered on 12 th July 2024 in Aura v Cabinet Secretary, Ministry of Health & 11 others; Kenya Medical Practitioners & Dentist Council & another (Interested Parties) [2024] KEHC 8255 (KLR)
15. The 2 nd respondent states that it has discharged its responsibility by issuing notice to all health facilities of the compliance requirement under the Data Protection Act, implemented through the office of the Data Protection Commissioner and that the issues raised in the Petition are in the sole mandate of the Data Protection Commissioner, the 4 th Respondent.
SUMMARY OF THE 6 TH RESPONDENT’S CASE
16. The 6 th respondent has filed a Notice of Preliminary Objection dated 25 th July 2024. The 6th Respondent objects to the Petition on grounds that it fails to plead, with the constitutionally required precision, the specific provisions allegedly violated and therefore discloses no justiciable constitutional cause. It is further contended that the issues raised fall within the exclusive statutory mandate of the Data Protection Commissioner under the Data Protection Act, 2019, rendering the Petition premature and offending the doctrines of ripeness, exhaustion, and constitutional avoidance. The 6th Respondent accordingly urges that the Petition be struck out at in limine .
17. In addition to the Preliminary Objection, the 6 th Respondent has filed a replying affidavit sworn on 25 th July 2024 by Judah Mutie Musyoka, a director of the 6th Respondent. He avers that the Petition and Application are misconceived, imprecise, and fail to disclose any constitutional violations with the degree of particularity required. He asserts that the issues raised fall within the exclusive jurisdiction of the Data Protection Commissioner under the Data Protection Act, and that the Digital Health Act, heavily relied upon by the Petitioners, was declared unconstitutional in Aura v Cabinet Secretary, Ministry of Health & 11 others; Kenya Medical Practitioners & Dentist Council & another (Interested Parties) (supra) , rendering it inapplicable.
18. He states that the 6th Respondent is a duly incorporated Kenyan company offering tele ‑ radiology services to enhance access to healthcare, particularly in light of the shortage of radiologists, high costs, and geographical barriers. He explains that the platform matches medical images uploaded by hospitals with qualified radiologists worldwide, whose reports are subsequently reviewed and validated by licensed Kenyan radiologists before release.
19. He denies that the platform uses artificial intelligence to generate diagnoses, stating instead that it merely facilitates secure transmission of images to human radiologists. He further asserts that the images transmitted “are not personal data capable of identifying the patient” and are accessible only to authorized radiology professionals. He adds that the platform has undergone rigorous quality assurance and is FDA ‑ cleared, demonstrating compliance with international standards.
20. The deponent highlights that the platform has served over 60,000 patients, supports 40 public health facilities, and engages numerous radiology professionals in Kenya. He contends that restraining the platform would cause grave harm to patients already onboarded, including potential loss of life due to delayed care. He further argues that the Petitioners’ actions reflect an attempt to “hoard the provision of health services” and resist technological advancement to the detriment of public interest.
21. He concludes that the Petitioners have not demonstrated a prima facie case or any public interest warranting the conservatory orders sought. He asserts that granting the orders would effectively determine the Petition prematurely and create an uncompetitive environment, contrary to societal progress. He therefore urges the Court to dismiss the Application and the Petition with costs.
SUMMARY OF THE PETITIONERS’ SUBMISSIONS
22. The Petitioner’s submissions are dated 5 th June 2025. It is submitted that the Petition is competent and that the Petitioners are entitled to the reliefs sought. It is submitted that, on account of the respondents' laxity, the patients' right to privacy is likely to be violated. Reference is made to the decisions in Kenya Human Rights Commission v Communications Authority of Kenya & 4 others [2018] eKLR and Centre for Human Rights and Democracy & another v the Judges and Magistrates vetting board & 2 others [2012]eKLR.
23. With regard to the Preliminary Objection, the Petitioner filed submissions dated 12 th August 2024.
24. The Petitioners oppose the 6th Respondent’s Preliminary Objection, arguing that it does not raise a pure point of law as required under Mukisa Biscuits Manufacturing Co. Ltd v West End Distributors Ltd [1969] EA 696. It is submitted that the Objection as framed does not raise a pure point of law and it should therefore fail. Refernce is made to the decision in Oraro v Mbaja [2005] eKLR.
25. They submit that the Petition clearly identifies the constitutional provisions allegedly violated as Articles 24, 27, 28, 31, 35, 41, 43 and 46, and sets out the factual matrix with precision in compliance with Rule 10 of the Mutunga Rules. Further, it is submitted that in line with Article 22(3)(b) of the Constitution, the Petition should not be dismissed, and reference is made to the decision in Michael Osundwa Sakwa v Chief Justice and President of the Supreme Court of Kenya & Anor [ 2016] eKLR .
26. They contend that the High Court has jurisdiction under Article 165(3)(b) to determine alleged violations of fundamental rights, and that the Data Protection Commissioner lacks constitutional interpretive authority. They further argue that the doctrines of ripeness, exhaustion and constitutional avoidance do not apply, as the Petition raises issues that can only be adjudicated through a constitutional petition The Petitioners therefore urge the Court to dismiss the Preliminary Objection with costs.
SUMMARY OF THE 2 nd RESPONDENT’S SUBMISSIONS
27. The Submissions of the 2 nd respondent are dated 24 th June 2025. Reference is made to the decisions in Anarita Karimi Njeru vs Republic (Supra) and Mumo Matemu vs Trusted Society of Human Rights Alliance & 5 Others [2013] eKLR on the failure of the Petition to disclose or demonstrate the constitutional provisions alleged to have been violated or infringed upon or threatened with infringement.
28. With regard to the Doctrine of exhaustion, reference is made to the decisions in Geoffrey Muhinja & Anor vs Emmanuel Muguna Henry & 1756 Others [2015] eKLR; Kirima v Solar Panda Company & Anor [2024] KEHC 11499 (KLR); Speaker of the National Assembly v Karume [1992]KECA 42 (KLR)
SUMMARY OF THE 6 TH RESPONDENT’S SUBMISSIONS.
29. The 6 th Respondent has filed two sets of submissions. The first is dated 1 st August 2024, and the rejoinder submissions are dated 29 th September 2025. The issue framed for determination is whether the 6 th Respondent’s Preliminary objection is meritorious. In addition to the celebrated decision in Mukisa Biscuits case ( supra), the 6 th Respondent relies on the decision in Nitin Properties Ltd v Singh Kalsi & Anor [1995] eKLR on the legal threshold for a meritorious preliminary objection.
30. It is further submitted that the Petition has not met the requirement in Anarita case (Supra) and Mumo Matemu case ( Supra). It is submitted that the Petition should therefore be dismissed as was held in Jamlic Muriithi v Law Society Of Kenya & another; Mathew Nyabena & 4 others (Interested Parties) [2021] eKLR.
31. The Petition, it is submitted should be struck out for offending the Doctrine of Exhaustion and reference made to the decisions in Miano & others v Attorney General & others [2021] eKLR; United Millers Limited v Kenya Bureau of Standards, Director, Directorate of Criminal Investigations & 5 others [2021] eKLR; Mwangi & Another v Naivasha County Hotel t/a Sawela Lodges (Petition E003 of 2021) [2022] KEHC 10975 (KLR) (19 July 2022) (Ruling) and Albert Chaurembo Mumba & 7 others (sued on their own behalf and on behalf of predecessors and or successors intitle in their capacities as the Registered Trustees of Kenya Ports Authority Pensions Scheme) v Maurice Munyao & 148 others (suing on their own behalf and on behalf of the Plaintiffs and other Members/Beneficiaries of the Kenya Ports Authority Pensions Scheme) [2019] eKLR
32. In the rejoinder submissions, the 6th Respondent contends that the Petition reiterates that the Petition is fatally defective for want of jurisdiction, precision and procedural propriety It is argued that the Petitioners have adopted “a scattergun approach to constitutional citation… without establishing any clear nexus between specific constitutional provisions and particular factual allegations.”
33. The Respondent reiterated that the true gravamen of the dispute concerns alleged breaches of statutory duties under the Data Protection Act and Digital Health Act, matters that fall within the specialised mandates of the Data Protection Commissioner and the Kenya Medical Practitioners and Dentists Council. The Petition therefore runs afoul of exhaustion, ripeness and constitutional avoidance. It is submitted that the High Court must defer to statutory mechanisms where Parliament has provided an alternative forum, emphasising that “even if all facts pleaded… are accepted as true, they invoke statutory rather than constitutional jurisdiction in the first instance.”
34. The Respondent further submits that its Preliminary Objection raises pure points of law because jurisdiction is determined solely from the pleadings, relying on Kenya Tea Growers Association v AG [2022] KEELRC 4124 (KLR) and Gcaba v Minister for Safety and Security2010 (1) SA 238 (CC) . It rejects the Petitioners’ claim that it introduced new grounds, asserting that describing the Petition as “a civil claim… couched as a constitutional grievance” is merely a legal characterization flowing from the pleaded objection. The Respondent argues that the Petitioners have not demonstrated any exceptional circumstances to bypass the exhaustion doctrine and that permitting the Petition to proceed would undermine the statutory dispute ‑ resolution framework and encourage forum shopping. It therefore urges the Court to uphold the Preliminary Objection and strike out the Petition in limine with costs, submitting that the Petition “remains vague and imprecise… and improperly invokes the original jurisdiction of this Honourable Court.”
ANALYSIS AND DETERMINATION
35. Having considered the pleadings, the submissions of the parties, and the applicable law, I frame the following issues for determination:
1. Whether the Preliminary Objection is meritorious?
2. Whether this Court has jurisdiction, or whether the Petition is barred by the doctrines of exhaustion, ripeness, or constitutional avoidance?
3. Have the Petitioners established violations or threatened violations of constitutional rights?
4. If the answer to (3) is in the affirmative, what remedies are appropriate?
Whether the Preliminary Objection is meritorious?
36. In Independent Electoral & Boundaries Commission v Cheperenger & 2 Others [2015] KESC 2 (KLR ), the Supreme Court articulated the strict parameters governing preliminary objections in Kenya. The Court emphasised that a true preliminary objection serves two important purposes: it shields the objecting party from unnecessary expenditure of time and resources, and it preserves scarce judicial resources for matters that warrant full adjudication. It is not to be wielded as a tactical device to short ‑ circuit a dispute that properly requires resolution on the merits.
37. It is equally well established that a preliminary objection may be raised only on a pure point of law. As the Court stated in Oraro v Mbaja [2005] KEHC 3182 (KLR), a matter cannot qualify as a preliminary objection if it is entangled with contested facts or if its foundation depends on evidence that must be tested through ordinary evidentiary processes. A preliminary objection must stand or fall on the face of the pleadings alone.
38. The Preliminary Objection before this Court is intertwined with several contested factual issues, including whether patient data is exported, whether the platform employs artificial intelligence, whether the images constitute personal data, and whether the Digital Health Act applies to the impugned conduct. These are matters that cannot be resolved without evidence and therefore fall outside the narrow scope of a proper preliminary objection.
39. I therefore find that the Preliminary Objection does not meet the Mukisa Biscuit threshold and must be dismissed.
40. I would add that the 6th Respondent proceeds on the mistaken assumption that the Digital Health Act is suspended. The correct position is that the High Court’s decision in Aura v Cabinet Secretary, Ministry of Health & 11 Others; Kenya Medical Practitioners & Dentists Council & Another (Interested Parties) [2024] KEHC 8255 (KLR) was stayed by the Court of Appeal in Cabinet Secretary, Ministry of Health v Aura & 13 Others [2024] KECA 1195 (KLR). The effect of that stay is that the Digital Health Act remains in force.
Whether this Court has jurisdiction, or whether the Petition is barred by the doctrines of exhaustion, ripeness, or constitutional avoidance?
In Macharia & another v Kenya Commercial Bank Ltd & 2 others [2012] KESC 8 (KLR) the Supreme Court directed thus-
A Court’s jurisdiction flows from either the Constitution or legislation or both. Thus, a Court of law can only exercise jurisdiction as conferred by the constitution or other written law. It cannot arrogate to itself jurisdiction exceeding that which is conferred upon it by law. We agree with counsel for the first and second respondents in his submission that the issue as to whether a Court of law has jurisdiction to entertain a matter before it, is not one of mere procedural technicality; it goes to the very heart of the matter, for without jurisdiction, the Court cannot entertain any proceedings. This Court dealt with the question of jurisdiction extensively in, In the Matter of the Interim Independent Electoral Commission (Applicant), Constitutional Application Number 2 of 2011. Where the Constitution exhaustively provides for the jurisdiction of a Court of law, the Court must operate within the constitutional limits. It cannot expand its jurisdiction through judicial craft or innovation. Nor can Parliament confer jurisdiction upon a Court of law beyond the scope defined by the Constitution. Where the Constitution confers power upon Parliament to set the jurisdiction of a Court of law or tribunal, the legislature would be within its authority to prescribe the jurisdiction of such a court or tribunal by statute law.
41. Article 165(3)(b) vests in the High Court the solemn duty of determining whether fundamental rights have been violated. That jurisdiction, once conferred by the Constitution itself, cannot be taken away by statute, nor diminished by administrative bodies, however eminent. The Petitioners say that, by reason of the omissions and acts of the respondents, there is a real risk that the rights of patients and their own rights may be infringed: the right to privacy under Article 31, the right to fair labour relations under Article 41, the right to health under Article 43(1)(a), and the rights of consumers under Article 46. These are not matters that can be tucked away into the remit of the Data Protection Commissioner or the Medical Practitioners and Dentists Council. They go deeper. They touch the very fabric of constitutional protections.
42. The doctrine of exhaustion holds an honored place in our system. It ensures that, as the Court of Appeal said in Muthinja & Another v Henry & 1756 Others (Supra), parties first pursue the remedies available to them before rushing to court. It is a sensible doctrine, fashioned to prevent the courts from being burdened with matters that can be resolved elsewhere. But, like all good principles, it is not absolute. As was observed in Wahome v Public Health Officers & Technicians Council & Another (Supra) , there are occasions when the doctrine must give way. When the complaint concerns the violation of constitutional rights, when the very legality of State action is called into question, the doors of the High Court cannot be shut. For the Constitution itself commands that they remain open
43. The exceptions were discussed in William Odhiambo Ramogi & 3 others v Attorney General & 4 others; Muslims for Human Rights & 2 others (Interested Parties) [2020] eKLR as follows,
What emerges from our jurisprudence in these cases are at least two principles: while, exceptions to the exhaustion requirement are not clearly delineated, Courts must undertake an extensive analysis of the facts, regulatory scheme involved, the nature of the interests involved – including level of public interest involved and the polycentricity of the issue (and hence the ability of a statutory forum to balance them) to determine whether an exception applies. As the Court of Appeal acknowledged in the Shikara Limited Case (supra), the High Court may, in exceptional circumstances, find that exhaustion requirement would not serve the values enshrined in the Constitution or law and permit the suit to proceed before it. This exception to the exhaustion requirement is particularly likely where a party pleads issues that verge on Constitutional interpretation especially in virgin areas or where an important constitutional value is at stake. See also Moffat Kamau and 9 Others v Aelous (K) Ltd and 9 Others.)
44. In this case, the Petitioners says that their rights and those of patients stand in jeopardy. They speak of threatened violations, not remote or fanciful, but real enough to warrant the Court’s attention. In such circumstances, the doctrines of exhaustion, ripeness, and constitutional avoidance cannot be used as barriers to shut the courthouse door. Where constitutional rights are at stake, and where the ordinary mechanisms offer no timely or adequate remedy, the High Court must step in. I therefore hold that this Petition falls squarely within the recognised exceptions to those doctrines
Have the Petitioners established violations or threatened violations of constitutional rights?
45. The Petition rests on a central contention: that the 2nd Respondent has failed to register the 6th Respondent, and that this omission carries significant implications for the rights of patients and for the Petitioners, who practice in the specialised and highly regulated field of radiology. Registration is not a procedural nicety. It is a statutory safeguard designed to ensure accountability, professional competence, and the protection of those who rely on medical services. Where such a safeguard is not observed, the potential consequences for constitutional rights cannot be dismissed.
46. Notably, the 2nd Respondent offers no substantive response to the allegation that it has failed to register the 6th Respondent. The Petitioners’ inquiry regarding the regulatory status of the 6th Respondent went unanswered. Nor does the 2nd Respondent dispute that the governing statute imposes a mandatory obligation to register all persons providing medical services. It is also uncontested, by both the 2nd and 6th Respondents, that the services offered by the 6th Respondent are radiology ‑ related. Yet the 6th Respondent appears before the Court as a private limited company, without evidence of compliance with the statutory framework governing medical practice. That silence is significant.
47. The 6 th respondent described it services thus-
[11] The 6 th respondent in keeping with every Kenyan’s Constitutional right to access to health care services and the right not to be denied emergency medical treatment has launched a program that allows patients to access radiology services by linking them to qualified professional radiologists world wide through the 6 th respondents platform which services are then supervised and validated by registered and licensed radiologists in Kenya in compliance with existing laws and regulations in the country.
[12] The 6 th respondent’s technological solution involves a patient visiting a hospital/ healthcare facility, which would then create an account for its patient and scan the medical image into the 6 th respondent’s platform, which would them match each case with the most qualified available radiologist who would then arrive at a diagnosis, write the report and send it back to the 6 th respondent which would then engage a qualified and licensed radiologist in Kenya to review and validate the report before formal issuance to the medical service provider ( hospital/ healthcare facility ) to manage the patient’s medical needs.
48. The 6th Respondent further states that, as at the time of filing the Petition, it had served more than 60,000 patients, and it describes the process through which those services are delivered. That figure underscores the magnitude of the operation and the breadth of its reach. It also heightens the constitutional stakes. When an entity providing radiology services engages with tens of thousands of patients, the question of regulatory compliance is not abstract. It bears directly on patient safety, professional oversight, and the constitutional and s
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