The Government of Karnataka has issued the Karnataka Private Medical Establishments (Amendment) Rules, 2018 (“Amendment Rules”), amending the Karnataka Private Medical Establishments Rules, 2009 (“Principal Rules”).
The Amendment Rules are not yet effective and will come into force once the State Government notifies it.
Please note that although the document is dated 27th March, 2018, it has been made available in the public domain recently.
Key Highlights of the Amendment Rules:
- Revised categories of private clinical establishments:
The Amendment Rules have revised the scope of private clinical establishments and added certain new categories of establishments within that scope. Few such examples are medical diagnostic laboratory, diagnostic imaging centre, blood bank, health check-up centre etc. Previously these categories were not mentioned separately under the scope of private clinical establishments.
- Revision of registration and renewal fees:
The Amendment Rules have substituted Rule 4 of the Principal Rules thereby revising the fees for processing of registration or renewal of private clinical establishments. The revised fees will be enhanced by 25% rounded off to nearest hundred Rupees every 5 years from the date of commencement of the Amendment Rules.
- Electronic method adopted for registration/ renewal of registration of establishments:
The Procedure of registration and renewal of the same has now been made electronic. Applications have to be made online on the IT portal of Health and Family Welfare Department. If there is any change in the information provided at the time of registration or renewal, the concerned establishment has to update the information in Form A or Form B, as the case maybe, on the IT portal of Health and Family Welfare Department with Aadhaar based electronic signing within one month from such change.
Every private clinical establishment has to apply for renewal of their registration three months prior to the due expiry of its five-year registration validity period. Prior to this, there was no separate provision on renewal of registration though the application form and fees for renewal were present.
- Reporting of notified diseases:
The Amendment Rules have inserted a new provision Rule 7B which lays down that every private clinical establishment, shall be required, as part of its registration conditions, to furnish details of the incidence of notified diseases among its patients to the Commissioner of Health and Family Welfare Services, Karnataka.
- Standards of Infrastructure, Staffing Pattern and Qualification of Staff:
A new provision Rule 9A has been inserted which states that till the time the Karnataka Government specifies the minimum standards of infrastructure, staffing pattern and qualification of staff, the existing private clinical establishments have to abide by the minimum standards as recommended by the National Council under the Clinical Establishment (Registration and Regulation) Act, 2010. Existing establishments will be given one-year grace period to comply with such minimum standards.
- Disclosure of Information:
A new provision related to information disclosure has been inserted by the Amendment Rules. Every private clinical establishment has to display its details in Form C with Aadhaar based electronic signing on the IT Portal of the Health and Family Welfare Department and on its website, if available.
For a detailed read of the Amendment Rules, please refer to the hyperlinked document.