The Kerala High Court on Wednesday issued a slew of directions to ensure patient welfare and to ensure effective implementation of the Kerala Clinical Establishments (Registration and Regulation) Act, 2018 (Act), key facility information, including bed categories, availability of ICU/OT, imaging and laboratory facilities and ambulance/contact details [Kerala Private Hospitals Association & anr v State of Kerala & ors and connected cases]
Among the directions, the Court ordered that hospitals should clearly display at the reception/admission desk and on its official website the list of services offered, baseline and package rates for commonly performed procedures.
The same should be done in Malayalam and English, the Court said.
Non-compliance with these guidelines shall attract regulatory action under the Kerala Clinical Establishments (Registration and Regulation) Act, 2018, including suspension or cancellation of registration and imposition of penalties, in addition to any civil, criminal, or constitutional remedies available to patients, the Court made it clear.
A Division Bench of Justice Sushrut Arvind Dharmadhikari and Syam Kumar VM passed these directions while upholding the Constitutional validity of the key provisions of the Kerala Clinical Establishments (Registration and Regulation) Act, 2018 (Act).
A single-judge of the High Court had earlier upheld the legality of the Act. This led to the appeal before the Division Bench
The Division Bench observed that the Act and its Rules constituted a lawful and reasonable regulatory framework aimed at safeguarding public health, ensuring transparency in billing and maintaining uniform healthcare standards across the state.
"The Act does not create new constraints; rather, it operationalizes these constitutional duties through a registration-cum- standards regime, a transparency mandate, and enforceable minimum requirements for emergency care and stabilization," the Court added.
The appellants had primarily challenged Sections 16(2), 39(2), 39(3) and 47 of the Act, which dealt with mandatory registration of clinical establishments, public display of treatment fees and package rates for the services that were offered and treatment of victims in emergencies.
They argued that these provisions were arbitrary, vague and impractical as they required hospitals to publish exhaustive employee data, display thousands of fee and package rates and imposed unrealistic obligations on smaller establishments which lacked infrastructure, manpower or transport facilities.
The Court, however, rejected the appellant's arguments on multiple grounds.
It first held that the state had full legislative competence to enact the Act as it fell under Entry 6 of the State List (List II) (regulation of public health, hospitals, and dispensaries) and that the Act was consistent with the constitutional guarantees under Article 21 (right to life) and Article 47 (Directive Principle mandating improvement of public health) of the Constitution.
The also Court rejected concerns about cancellation of registration or lack of a registration timeline, noting that the Act offered sufficient procedural safeguards, including notice by authorities, opportunity to show cause, appeal, revision and grievance redressal.
It next upheld the requirement for establishments to display fee rates and package rates clarifying that the Act did not impose uniform state fixed rates but only required hospitals to disclose their own charges to ensure transparency and to protect patients from unexpected billing.
With respect to life saving services, the Court found that the Act placed category-specific responsibilities across primary, secondary and tertiary institutions.
Addressing privacy concerns surrounding Form 2A, the Court clarified that most employee information was already available through the National Medical Registry and that all data submitted was securely stored by NIC, accessible only to authorised officials, further adding that inconvenience or speculative fears could not be grounds for invalidating a legislation.
"For all the reasons stated above, we hold that the validity of the impugned Sections 16, 39, and 47 of the Kerala Clinical Establishments (Registration and Regulation) Act, 2018, along with the allied Rules and Schedules, is intra vires and requires no interference. The provisions are neither vague nor disproportionate and are in conformity with global standards, as discussed in the preceding paragraphs," the Court added.
While dismissing the appeals, the Court also observed that although the Act had been in force for 7 to 8 years, many private hospitals had not taken steps to comply with the transparency and emergency care obligations.
Thus, it issued a comprehensive set of guidelines to ensure that the Act is effectively implemented:
Every clinical establishment must stabilise emergency patients within their capacity, ensure safe documented transfer, provide life-saving aid without insisting on advance payment, and hand over all investigation reports at discharge.
Clearly display services, rates, facilities, patient rights, and grievance contacts in Malayalam and English at reception areas and on their official websites.
A brochure and downloadable PDF must list services, rates, billing rules, insurance details, discharge procedures, emergency protocols, and grievance steps in English and Malayalam.
They must have a grievance desk, issue reference numbers, resolve complaints within seven days, escalate serious issues to the DMO, and maintain a monthly complaint register.
All displayed rates, brochures, and website information must remain accurate and updated, with every revision clearly dated for clarity.
At the time of discharge of a patient from the hospital, the hospital authorities shall ensure that, along with the discharge summary, all investigation reports pertaining to the treatment, such as ECG, X-ray, CT scan, and other test reports, are also handed over to enable the patient to maintain proper records.
A compliance undertaking must be filed within 30 days. District Authorities must verify compliance through audits within 60 days and act on any lapses.
Patients shall approach consumer forums, file police complaints, seek support from Legal Services Authorities and receive receipts for every payment and complaint.
All mandatory information must be provided in Malayalam and English, clearly visible at hospitals and easily accessible online for patients.
Failure to comply may lead to penalties, suspension or cancellation of registration, and possible civil or criminal liability.
District level grievance cells must function with time bound complaint handling and periodic compliance audits, especially on emergency care and excess billing
Regular training and drills on triage, stabilisation, infection control and safe transfer protocols must be conducted while following recognised guidelines.
The Court directed the Registrar to send the judgment to the Chief Secretary and State Police Chief to ensure strict enforcement of the Act and these guidelines. It also directed the S tate to publicise the key directions in print and visual media for a month and to file a compliance report.
The appellants were represented by Senior Counsel VV Asokan.
The State was represented by state attorney N Manoj Kumar
[Read Judgment]