Kinds of Clinical Business License, Promising Health Business
“Health facility services (fasyankes) are always sought after by the community. One type of health facility is a clinic.”
The community’s need for health services is a need that will never end. Even from 2020 to 2021, the transaction value of the health sector will reach IDR 490 trillion. That is the data expressed by the Minister of Health Budi Gunadi Sadikin.
The high transaction value in the health sector proves that both the government, the private sector, and the public are willing to spend more to live up to health needs.
It is not surprising that health-related businesses look so promising. One type of business working in the health sector is a clinic business.
Definition and Classification of Clinical Business
Based on the Regulation of the Minister of Health Number 9 of 2014 concerning Clinics (Permenkes Number 9 of 2014) and its amendments, clinics are health facilities that provide individual health services that provide basic and/or specialist medical services.
In simple terms, a clinic is a business that provides health service facilities (fasyankes).
Referring to the Regulation of the Minister of Health Number 14 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector (Permenkes Number 14 of 2021), clinics have three business groups, including:
- Service Ability
- Pratama clinic is a clinic that provides basic medical services
- The main clinic is a clinic that provides specialized medical services or basic and specialist medical services (for example special maternity clinics, skin and beauty clinics, and so on)
- Service Implementation
- Outpatient clinic; and/or
- Inpatient clinic
- Capital ownership
- Domestic investment clinic (PMDN)
- Foreign investment clinic (PMA)
Parties who can run a clinical business can come from various groups, both government, local government, and the community. For business actors from the community, including those established by the health workers themselves, it is called a private clinic business.
Risk-Based Business Licensing for Private Clinical Businesses
Determination of Indonesia Standard Industrial Classification (KBLI) is the first step that should be considered by every business actor who establishes a business activity, including a clinical business.
The KBLI that allows for private clinics is indicated by code 86105 entitled “Private Clinic Activities.” The business group in this activity includes health care and physical treatment managed by the private sector, both outpatient and inpatient care.
Businesses belonging to KBLI 86105 could be established by all categories of business activities, from small, micro, mediate, to large businesses. All of these categories have a medium-high risk level.
Based on Government Regulation Number 5 of 2021 concerning the Implementation of Risk-Based Business Licensing (PP Number 5 of 2021), business licensing with a medium to high-risk level includes:
- Business Registration Number (NIB)
- Standard Certificate
NIB is proof of registration and identity for business actors in carrying out their business activities. NIB could be managed through the Online Single Submission (OSS) system.
Meanwhile, the standard certificate is the legality to carry out business activities. The standard certificate document is in the form of a statement by business actors to meet the relevant business standards provided through the OSS System.
It should be remembered that standard certificates for businesses with medium to high categories must be verified first by the central government, regional governments, and/or related certification bodies before they can be issued (PP Number 5 of 2021).
Standards of Clinical Business Activities
Based on the Regulation of the Minister of Health Number 26 of 2018 concerning Electronically Integrated Business Licensing Services for the Health Sector (Permenkes Number 26 of 2018), business actors are required to obtain an operational permit before carrying out their business activities.
The operational permit in question is in the form of a standard certificate for related business activities. Therefore, private clinic business actors are required to meet the business standards set by the government.
Clinical business standards (including private clinics), which must be met, include (Attachment to Permenkes Number 14 of 2021):
- General requirement:
- Private clinics with outpatient services can take the form of:
- Individuals;
- Business entity; or
- Legal entity
- Private clinics with inpatient services can take the form of:
- Business entity; or
- Legal entity
- Clinics with PMA can only be in the form of a limited liability company
- Document letter from the district/city Health Office regarding the consideration of approval for the establishment of a clinic
- Clinical profile documents, including:
- Full name and address
- Vision and mission
- Organizational structure
- Clinic run time
- Clinical self-assessment
- Clinical self-assessment documents, including:
- Clinical service capabilities
- Medical support services (pharmaceutical and laboratory)
- Fulfillment of facilities and infrastructure requirements
- Equipment
- Human Resources (HR)
- The duration of standard fulfillment by business actors for new permits is three months from the date of issuance of the NIB
- Private clinics with outpatient services can take the form of:
- Specific Requirements:
- List of facilities, infrastructure, buildings, equipment, and list of medicines and consumables
- List of HR by the authority and competence and organizational structure
- List of types of health services at the clinic
- Practice License Document (SIP) for all health workers who work in clinics
- Document of a cooperation agreement on hazardous and toxic waste disposal (B3)
- Permit Document Employing Foreign Workers (IMTA), if the clinic employs Foreign Workers (TK-WNA)
- Fulfill the facilities under what has been determined
- Has an organizational structure and HR, which includes:
- The primary clinic consists of at least:
- 2 general practitioners
- 2 specialist doctors in primary care
- 2 dentists
- Main Clinic, has at least 2 specialist doctors
- The primary clinic consists of at least:
- Services, namely the following:
- Standard scope of service
- Service time
- Form of service
- The type of service is following what has been determined and is provided by taking into account the principles of patient safety
- Product/process/service requirements
Health services provided at the clinic must be under service standards and professional standards of health workers set/ratified by the Minister of Health. - Business Management System
Following what has been determined by the Minister of Health.
Verification of Compliance with Business Standard Commitments
As mentioned earlier, private clinical business activities are classified as businesses with a medium to high-risk level, so standard certificates that have been fulfilled by business actors are required to be verified by the central government, regional governments, and/or certification bodies.
Therefore, business actors are required to submit and report complete business standard requirements documents to the central government, regional governments, and/or certification bodies so that they could be verified.
Verification of the fulfillment of clinical business standards regulated in the Minister of Health Regulation Number 14 of 2021 is as follows:
- The verification mechanism is carried out by:
- Administrative verification could be done through the Application (Electronic system); and
- Field Verification carried out through field visits
- No later than 10 days after the business actor submits the complete required documents, the Ministry of Health/Regency/City Health Office evaluates the completeness of the required documents and field visits.
- Based on the results of the evaluation, no later than 10 days after the field visit, the Ministry of Health/Regency/City Health Office will provide notification of approval or improvement of standard compliance through the OSS system.
- The validity period of the Clinical Business Standard Certificate is valid for five years and can be extended again as long as it meets the requirements
Responsibilities of Business Actors
After fulfilling the requirements for business licensing, private clinic business actors also have several obligations, including (OSS Institution – Investment Coordinating Board):
- Registering clinics through the Health Service Facility Registration application belonging to the Ministry of Health
- Organizing clinical health services according to applicable standards
- Reporting the results of clinical health service activities by applicable regulations
- Do update data if there is a change in clinical data
Do you still confused about how to manage the legality of a private clinic business? Don’t hesitate to consult us, Prolegal!
Author: Faiz Azhanzi Yazid
Editor: Bidari Aufa Sinarizqi
Translator: Angelie Kartika Putri