Licensing is a grant of permission issued to a Healthcare Establishment (HCE) by the Islamabad Healthcare Regulatory Authority (IHRA) under the IHR Act 2018 for the use of any premises or conveyance as a Healthcare Establishment.
Licensing is a mandatory process and no Healthcare Establishment can function or operate without obtaining license from the IHRA. Licensing focuses on the enforcement of quality healthcare service standards (QHSS) for delivery of healthcare services. It sets out standards that a Healthcare Establishment must observe and implement in order to operate and deliver quality healthcare services.
(Every license of a healthcare establishment shall specify the kind of healthcare establishment for which it is issued and the purposes of the healthcare establishment. A licensed healthcare establishment shall not be used for any purpose other than the purposes in respect of which the license is issued and purposes incidental to such purposes. Alongside, it is the responsibility of IHRA to maintain a register of all licensed healthcare establishments).
Note: A Healthcare Establishment (HCE) means any premises used or intended to be used for the provision of healthcare services, including but not limited to a hospital, teaching hospitals, surgical centers, maternity homes, nursing homes, clinics, dispensaries, dentistry, dental clinics, clinical laboratories, x-ray laboratories, diagnostic centers, ambulatories, cosmetic centers, psychiatric hospitals, burn units. psychiatric nursing home, community mental health center, hemodialysis center, dialysis center, patient rehabilitation center, slimming clinic or center, hair transplant clinic, domiciliary care, home based services and such other healthcare or health-related premises as the Federal Government may, by notification in the official Gazette, specify.
LICENSING IS MANDATORY
All HCEs in ICT, both in the public and private sectors, are required to obtain a license from the IHRA. If a Healthcare Establishment fails to be licensed under the IHR Act 2018 within a required period of time, the IHRA may impose a fine which may extend to Rs. 1,000,000 or order the closing down of the Healthcare Establishment.
Whoever himself or by any other person on his behalf establishes any healthcare establishment without registration or a license shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to one million Rupees or with both:
Note: “Presently we are only registering healthcare establishments, provisionally & not issuing Licenses, due to administrative issues”.
IHRA has a well-defined and transparent process for licensing of HCEs, which is initiated, when the HCE is registered with IHRA.
- The Authority shall, on receipt of an application, invite HCE to nominate staﬀ for training on QHSS, intended to facilitate HCE staﬀ in the implementation of standards.
- The Authority, before issuing the license, carries out a pre-assessment of the healthcare establishment which is to be licensed, where IHRA inspection team further assist HCE staﬀ in identifying and eliminating gaps in QHSS implementation.
- After allowing HCEs a reasonable period of time to ensure implementation of QHSS, a formal inspection assessing the HCE’s eligibility for license constitutes the final step in the licensing process, where an HCE is deemed eligible upon demonstration of desired compliance levels to the QHSS.
- In near relevance, a license that is issued by IHRA, under the mentioned section, shall be in such form; as may be prescribed, alongside, shall be valid for a period of 5 year, and may be renewed upon expiry.
At the time of Licensing, a Healthcare Establishment is required to pay a non-refundable fee to the IHRA depending upon the type of Healthcare Establishment.
RENEWAL OF LICENSE
The license shall be valid for a period of five years and may be renewed upon expiry. The healthcare establishment shall make a request for the renewal of its License prior to the expiration date. A renewed License shall not be issued unless the License fee is received by the IHRA. The license will not be renewed if the IHRA regulations and/or requirements are not met.
REVOCATION AND SUSPENSION OF LICENSE
A License granted to a HCE can be suspended or revoked or refused for renewal if it fails to comply with the standards set forth in the QHSS, violates provisions of the IHR Act 2018, involved in instances of serious medical negligence and system failures, indulges in fraud or misrepresentation to obtain a License, refuses to undergo inspection and/or fails to comply with the Licensing Regulations of the IHRA.