A Closer Look at the Standards of Medical Services under GR 28/2024
On July 26, 2024, the Government of the Republic of Indonesia issued Government Regulation No. 28 of 2024 ("GR 28/2024"), which serves as an implementing regulation for Law No. 17 of 2023 on Health (“Health Law”). GR 28/2024 encompasses a broad scope of provisions concerning the implementation of the stipulations in the Health Law.
Due to the extensive range of provisions covered under GR 28/2024, this Newsflash will discuss solely on the standard for medical services provision.
GR 28/2024 provides a significant development regarding the medical services regulation in Indonesia. Further, GR 28/2024 comprehensively outlines standards for both primary and advanced medical services, addressing critical aspects such as healthcare quality, access, and the integration of modern technology into medical practice. GR 28/2024 introduces new provisions for medical services in remote areas, the use of telemedicine, and the role of digital health technologies. These changes are intended to enhance the effectiveness of medical services while ensuring they align with evolving global standards.
This Newsflash focuses on the updated standards for primary and advanced medical services, the medical services in special areas, and the technology in the healthcare sector.
♦ Primary and Advanced Medical Services
As mentioned above, GR 28/2024 establishes comprehensive standards for both primary and advanced medical services. Primary medical services (Pelayanan Kesehatan Primer) are the medical services closest to the community, serving as the first point of contact for health services. While advanced medical services (Pelayanan Kesehatan Lanjutan) focus on specialized care for patients, while also considering earlier treatments and maintaining overall patient’s health condition provided by the competent medical workforce.
Primary medical services aim to meet the community's health needs at every stage of life by enhancing the determinants of health or factors that may impact health, such as social, economic, commercial, and environmental factors.
Primary medical services are provided by community health centers (Puskesmas) or equivalent primary care providers in the area. These services are delivered through a coordinated medical network system to improve coordination between different healthcare levels, reduce delays and enhances patient outcomes, especially for specialized care. One of the forms of coordinated medical network system is a referral system, where medical service facilities refer patients to advanced centers when necessary.
The referral system is conducted through 3 (three) types of referrals, namely:
- Vertical referral
A vertical referral is a referral from a medical service facility to another facility with a higher level of capability that aligns with the patient's medical needs. - Horizontal referral
A horizontal referral is a referral from a medical service facility to another facility at the same level of care but with specific competencies that the referring facility does not possess. - Back-referral
A back-referral is the process of referring patients who have completed treatment at a higher-level medical service facility back to a lower-level facility for continued care or further treatment.
♦ Medical Services in Special Areas
A key aspect of GR 28/2024 is its focus on standardizing the quality of care across healthcare facilities. While the previous regulation, Government Regulation No. 47 of 2016 on Traditional Health Services (“GR 47/2016”), provided certain guidance, GR 28/2024 revoked GR 47/2016 and sets forth more comprehensive standards for patient care, which aims to address disparities in healthcare quality between urban and rural regions.
GR 28/2024 highlights the importance of delivering medical services in special areas, such as remote areas, border zones, islands, as well as in health-problems areas or underserved areas (these areas referred to as “Special Areas”). GR 28/2024 recognizes the distinct challenges encountered in these areas, including inadequate infrastructure, challenging geographical conditions, and a shortage of healthcare professionals. It assigns responsibility to both central and regional governments to ensure that residents in these regions have access to quality medical services.
While the focus on healthcare accessibility in remote and underserved areas was already regulated in GR 47/2016, GR 28/2024 introduces substantial updates to these provisions. For instance, it introduces integrated health information systems that enable effective monitoring and linkage of medical services to national databases. This initiative aligns with the government’s vision to improve healthcare delivery for marginalized communities and to tackle infrastructural challenges, such as the lack of adequate facilities and resources in Special Areas.
Medical facilities in Special Areas must be adapted to meet the specific conditions and issues of each area. Further, Article 547 of GR 28/2024 stipulates that all health data recording and reporting for all healthcare facilities in these areas must be integrated into the national health information system. In this regard, the implementation for this provision will be regulated in a separate Minister of Health regulation.
♦ Technology in Healthcare Sector
Previously, provisions regarding technology in healthcare sector were regulated under Government Regulation No. 46 of 2014 on Health Information Systems, which was revoked by GR 28/2024. On that note, GR 28/2024 introduces provisions for the integration of Information and Communication Technology (ICT) to enhance access to and the quality of medical services in Indonesia. This includes incorporating telemedicine and telehealth into the delivery of medical services.
Telemedicine facilitates remote clinical services, which enable healthcare professionals to diagnose and manage diseases without requiring patients to travel. Meanwhile, telehealth encompasses a broader range of services, including both clinical and non-clinical consultations. GR 28/2024 further stipulates the requirements for medical service facilities offering telemedicine and telehealth, including the need for adequate infrastructure, reliable internet connectivity, and adherence to national data security standards.
AKSET
Please contact Adhitya Ramadhan (aramadhan@aksetlaw.com), M. Fatih Satria Kasmaliputra (mkasmaliputra@aksetlaw.com), or Azzahra Saffanisa S. (asudiardiputri@aksetlaw.com) for further information.
Disclaimer:
The foregoing material is the property of AKSET and may not be used by any other party without prior written consent. The information herein is of general nature and should not be treated as legal advice, nor shall it be relied upon by any party for any circumstance. Specific legal advice should be sought by interested parties to address their particular circumstances.
Any links contained in this document are for informational purposes and are available and relevant at time this publication is made. We provide no liability whatsoever in respect of any information or content in such links.
A Closer Look at the Standards of Medical Services under GR 28/2024
Health Omnibus Law Series – Patients' Consents For Medical Actions
This Newsflash is part of our Health Omnibus Law Newsflash series with respect to the issuance of Law No. 17 of 2023 dated August 8, 2023 on Health (the “Health Law”). As noted in our previous Newsflashes, the Health Law is issued using an omnibus method, revoking several laws and regulations in the health sector (including, among others (i) Law Number 29 of 2004 on Medical Practices (“Law 29/2004”) and (ii) Law Number 36 of 2014 on Health Workers (“Law 36/2014”).
In brief, the Health Law is issued with the intention to enhance public health development for the achievement of national objectives in safeguarding the entire Indonesian citizen to advance the general welfare.
One of the key provisions under the Health Law is the provision on the approvals of medical or dental practice and healthcare workers actions. The several changes from the previous provisions stipulated in Law 29/2004 and Law 36/2014 are as follows:
Consolidation of Provisions Regarding Approval of Action by Medical or Dentistry Practice and Approval of Action by Health Worker
Previously, the approval of action by Medical or Dentistry Practice was stipulated under Law 29/2004, while the approval of action by Health Workers stipulated in a separate regulation i.e., the Law 36/2014. Currently, the Health Law consolidated these two provisions under Paragraph 5 of the Health Law regarding the Approval of Action by Healthcare Services.
The Health Law also governs the new term i.e., "Medical Action" to describe and cover the actions that undertaken by both Physicians or Dentists
Additional Prior Explanation for Obtaining Consent from Patients
Article 45(3) of Law 29/2004 and Article 68(3) of Law 36/2014 govern a similar specific explanations that must be provided before the patients were requested to grant a consent for the action of the health service, which are as follows:
[Article 45, paragraph (3) of Law 29/2004]
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- diagnosis and medical procedure methods;
- purpose of the medical procedure;
- alternative procedures and the risks;
- possible risks and complications; and
- prognosis of the procedure.
[Article 68, paragraph (3) of Law 36/2014]
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- procedures for healthcare services;
- purpose of the healthcare service procedure;
- alternative procedures;
- potential risks and complications; and
- prognosis of the procedure.
Similar to the above, the Health Law also govern the same provisions with the above with the additional explanation on the (i) indications and (ii) risks if the action was not performed. We set out below the provision on the explanation obligation under Article 293 paragraph (3) of the Health Law:
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- diagnosis;
- indications;
- performed Healthcare Service Actions and their purposes;
- potential risks and complications;
- alternative procedures and their risks;
- risks if the action was not performed; and
- prognosis after undergoing the action.
♦ Requirement of the Written Consent
Previously, Law 29/2004 and Law 36/2014 only govern that written consent must be signed by the patient or their representative. Currently, Article 293 paragraph (8) of the Health Law specifically govern that the signing of written consent must be witnessed by a Medical Professional or Healthcare Worker.
Emergency Action Consent
Please note that Law 29/2004, Law 36/2014, and Health Law govern the exemption of obtaining consent for emergency actions in order to protect the patient's best health needs, e.g., in the condition to preserve life and/or prevent disability for the patients. In this regard, Article 293, paragraph (9) of Health Law further stipulates that the consent is not required, if in such emergency situation, the patient was not eligible to provide consent and there was also no other person eligible for providing such consent for the patient.
♦ Requirement of Explanation on Health Service Cost
Article 294 of the Health Law stipulates that patients are entitled to receive explanations from Healthcare Facilities with respect to the costs of the Healthcare Services they received. This provision in the Health Law complements the provision under Law 36/2014, which does not cover the explanation of cost calculation for the performed procedures, and Article 45, paragraph (3) of Law 29/2004, which only broadly mentions that patients should be provided with explanations regarding the incurred cost. The explanation of the cost as stipulated on Health Law is to give the patient the hospital price transparency and to prevent the medical bill surprise.
♦ Requirement on the Health Service Programs from the Government
Article 295 of Health Law stipulates that the Health Services Program from the government does not need a consent from patients. However, the healthcare services must still be communicated to the recipients of those health services. This provision aligns with the provision in Article 69 of Law 36/2014 and Article 15 of Ministerial Regulation 290/2008 concerning Approval of Medical Actions, which is a derivative regulation of Law 29/2004.
October 30, 2023
AKSET
Please contact Johannes C. Sahetapy-Engel (jsahetapyengel@aksetlaw.com), Raymont Travis (rtravis@aksetlaw.com), or Azzahra Saffanisa Sudiardiputri (asudiardiputri@aksetlaw.com) for further information.
Disclaimer:
The foregoing material is the property of AKSET and may not be used by any other party without prior written consent. The information herein is of general nature and should not be treated as legal advice, nor shall it be relied upon by any party for any circumstance. Specific legal advice should be sought by interested parties to address their particular circumstances.
Any links contained in this document are for informational purposes and are available and relevant at time this publication is made. We provide no liability whatsoever in respect of any information or content in such links.
Health Omnibus Law Series – Patients' Consents For Medical Actions
Health Omnibus Law Series – Health Law Replaces Law No. 44 of 2009 on Hospitals
This Newsflash is a part of our Health Omnibus Law Newsflash Series on the issuance of Law No. 17 of 2023 dated August 8, 2023 on Health (the “Health Law”). The Health Law governs a wide range of topics in the health sector, including provisions on hospital matters. The Health Law repeals and replaces several laws including Law No. 44 of 2009 dated October 28, 2009 on Hospitals (the “Hospital Law”).
This Newsflash discusses the pertinent changes on hospitals. Please see below the notable provisions related to Hospitals under the Health Law.
♦ General Overview on Hospitals
Previously, the Hospital Law defined a hospital as a health service institution that organizes a complete individual health services that provides inpatient, outpatient and emergency services. As for patients, under the Hospital Law a patient was defined as any person who consults about his or her health problems to obtain the necessary health services, either directly or indirectly at a Hospital.
Now, the Health Law introduces more thoroughs definitions of a hospital and a patient. Under the Health Law, a hospital is defined as a health service facility that organizes a complete individual health services through promotive, preventive, curative, rehabilitative and/or palliative health services by providing inpatient, outpatient and Emergency Care services. A patient is defined as any person who obtains the health services from medical personnel and/or healthcare personnel.
♦ Notable Changes in Health Law
In the Hospital Law, a hospital could be designated as a teaching hospital after the requirements and standards were met. It was also stated that the title of teaching hospitals would be determined by the Minister of Education and Culture of the Republic of Indonesia.
The Health Law now regulates certain new provisions about teaching hospitals, including the new definition of a teaching hospital which is defined as a hospital that has a function as a place of education, research and healthcare services in an integrated manner in the education for medical personnel and healthcare personnel sector as well as multi-professional continuing education.
Under the Health Law, a teaching hospital shall cooperate with a higher education institution to organize an academic education program, a vocational program, and a professional program, including a specialist, or a subspecialist program. In organizing the education, a teaching hospital must meet the requirements, standards and accreditation.
After such fulfilment of the requirements as stated above, the Minister of Education and Culture, along with the relevant accreditation bodies, will grant a permission to a teaching hospital.
♦ Obligations and Rights of Hospitals and Patients
Obligations of Hospitals
Pursuant to the Health Law, a Hospital is required to perform the following obligations:
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- to provide correct information about Hospital services to the public;
- to provide the health services that is safe, quality, anti-discriminatory with prioritizing patients’ interests in accordance with hospital service standards;
- to provide emergency services to patients according to their service capabilities;
- to play an active role in providing health services in the event of disasters according to its services ability;
- to provide facilities and services for underprivileged community or people;
- to carry out social functions, among others, by providing service facilities for underprivileged patients, emergency services without down payment, free ambulance, service for victims of disasters and extraordinary events, or social services for humanitarian missions;
- to create, implement, and maintain the quality standards of health services in hospitals as a reference in serving patients;
- to organize medical records;
- to provide proper public facilities and infrastructures, including places of worship, parking lots, waiting rooms, facilities for persons with disabilities, breastfeeding women, children and the elderly;
- to implement a referral system;
- to reject the patient's wishes that are contrary to professional and ethical standards and applicable regulations;
- to provide correct, clear and honest information regarding the rights and obligations of a patient;
- to respect and protect the rights of a patient;
- to implement the hospital ethics;
- to have an accident prevention and disaster management system;
- to implement the government programs in the health sector, both regionally and nationally;
- to make a list of medical personnel who practice medicine or dentistry and other healthcare personnel;
- to formulate and implement internal regulations of the Hospital;
- to protect and provide legal assistance to all of the staff members of the hospital in carrying out their tasks; and
- to enforce the entire hospital environment as a smoke-free area.
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The Health Law does not introduce any changes with respect to the obligations of hospitals as listed above. However, the Health Law introduces a set of obligations for Health Services Facilities which include hospitals. Therefore, a hospital will be subject to the following obligations set out for the Health Services Facilities:
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- to provide broad access to the needs of services, education, research and service development in the health sector;
- to organize quality health services and prioritizing a patient’s safety;
- to organize medical records;
- to report on the results of services, education, research and development to the Central Government with a copy to the relevant Regional Government through the Health Information System;
- to make efforts to utilize the results of services, education, research and development in a system as an effort to overcome health problems in the regions; and
- to establish the standard operating procedures with reference to health services standards.
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Rights of Hospitals
The Health Law stipulates that a hospital has the following rights:
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- to determine the number, types, and qualifications of human resources according to the hospital’s classification;
- to receive compensation for services and determine remuneration, incentives, and awards according to the provisions of laws and regulations;
- to cooperate with other parties in developing services;
- to receive assistance from other parties in accordance with the provisions of laws and regulations;
- to claim any party that causes losses to the hospital;
- to obtain legal protection in implementing health services; and
- to promote health services in hospitals in accordance with prevailing laws and regulations.
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Obligations of Patients
In relation to the obligations and rights of patients, the Health Law determines the following obligations of patients:
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- to provide complete and honest information about their health problem;
- to comply with the advice and instructions of Medical Personnel and Healthcare Personnel;
- to comply with the provisions that apply to Health Service Facilities; and
- to pay compensation for services received.
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Rights of Patients
Patients have the following rights:
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- to obtain information about their own health;
- to obtain adequate explanation regarding the Health Services they receive;
- to obtain the Health Services in accordance with medical needs, professional standards, and services quality;
- to refuse or agree to any medical action, except for a medical action required for prevention of infectious diseases and management of outbreaks or extraordinary events;
- to have an access to the information contained in the medical records;
- to ask for the opinion of Medical Personnel or Healthcare Personnel; and
- to obtain other rights in accordance with applicable laws and regulations.
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We note that the Health Law does not introduce any major change with respect to the obligations and rights of Hospitals and Patients as set out under the previous Hospital Law.
♦ Hospital Legal Protection and Legal Responsibility
The Health Law provides that a hospital is not legally responsible if a patient and/or his or her family refuses or discontinues a treatment which may result in the death of the patient after a comprehensive medical explanation.
A hospital may not be prosecuted for carrying out its duties in saving human lives.
As to the legal responsibility, the Health Law provides that a hospital may be held legally responsible for all losses incurred due to negligence carried out by the health personnel of the hospital.
Please note that the implementing regulations of the Hospital Law continue to be valid as long as the regulations are not contrary to the Health Law.
September 19, 2023
AKSET
Please contact Johannes C. Sahetapy-Engel (jsahetapyengel@aksetlaw.com), Thomas P. Wijaya (twijaya@aksetlaw.com), or Rae Chalista (rchalista@aksetlaw.com) for further information.
Disclaimer:
The foregoing material is the property of AKSET and may not be used by any other party without prior written consent. The information herein is of general nature and should not be treated as legal advice, nor shall it be relied upon by any party for any circumstance. Specific legal advice should be sought by interested parties to address their particular circumstances.
Any links contained in this document are for informational purposes and are available and relevant at time this publication is made. We provide no liability whatsoever in respect of any information or content in such links.
Health Omnibus Law Series – Dispute Settlements between Health Personnel and Patients
This Newsflash is part of our Health Omnibus Law Newsflash series with respect to the issuance of Law No. 17 of 2023 dated August 8, 2023 on Health (the “Health Law”). As noted in our previous Newsflash, the Health Law is issued using an omnibus method. The Health Law revokes several laws in the health sector, including Law No. 36 of 2009 dated October 13, 2009 on Health (the “Previous Health Law”).
The Health Law governs a wide range of topics in the health sector, including the procedures of settling disputes arising between health personnels and patients.
We highlight the key dispute settlement related provisions under the Health Law, as follows.
♦ Obligation for Health Personnel to Form a Panel of Council in order to Uphold Professional Discipline
The Health Law acknowledges the importance of the enforcement of the Professional Discipline to all health personnel. The Health Law requires the Minister of Health of the Republic of Indonesia (the “Minister”) to form a panel of council to uphold and carry out the duties with respect to the Professional Discipline. The panel of councils may be formed permanently or on an ad hoc basis, at the Minister’s discretion.
The patients or their families whose interests are violated by an action of health personnel may submit a complaint to the panel of council. The complaint shall include at least the following information: (i) the identity of the complainant, (ii) the name and address of the place where the health personnel carry out his/her practice, and (iii) the reason for the complaint. Subsequently, the panel of council will determine whether or not there is a violation of Professional Discipline by the relevant health personnel in providing the health services.
The Health Law governs that any violation of Professional Discipline will be followed up with various forms of sanctions, including (i) a written warning, (ii) an obligation to attend certain education or training session(s) at education providers in the health sector or the nearest teaching hospital which has the competency to conduct the said training, (iii) suspension of the health personnel’s registration certificate (Surat Tanda Registrasi), and/or (iv) a recommendation of practice license (Surat Ijin Praktek) revocation.
Following the decision of the panel of council, under the Health Law it is possible for a patient and/or the relevant health personnel to file a petition for reconsideration (Peninjauan Kembali), as long as any of the following conditions is met: (i) new evidence is discovered, (ii) misapplication of disciplinary violations, or (iii) there was an alleged conflict of interest between the examiner and the examinee.
♦ Obligation for Panel of Council to Issue Recommendation Letters to Examine Health Personnel Suspected of Criminal Actions
Health personnel who are suspected of committing criminal actions may be subject to criminal sanctions. In this regard, the Health Law requires a Civil Servant Investigator Officer or the Indonesian National Police Officer to submit a written request to the panel of council to conduct an investigation on certain suspected health personnel. The panel of council is obliged to issue a recommendation letter within 14 (fourteen) days following the receipt of such written request. The Health Law specifically provides that the recommendation letter issued by the panel of council must contain a written statement to state whether or not the investigation may be carried out, along with the consideration and the basis of the recommendation.
We also note that a recommendation letter issued by the panel of council is not only obligatory for commencing investigation towards any health personnel who are suspected for conducting criminal acts, but also for health personnel who are suspected of conducting civil violations (e.g., causing damages or other material losses to the patients).
♦ Obligation for Health Personnel and Patients to Settle Amicably
In general, the Health Law recommends health personnel and patients to first attempt to settle any dispute amicably outside a court of law.
If the health personnel are suspected of carrying their profession in a manner that causes losses and damages to a patient, any dispute arising of that default shall first be settled through an alternative dispute resolution process outside a court of law.
We note that there are several distinctions in the provisions regarding dispute settlement between the Previous Health Law and the Health Law. The main differences of these two laws in this regard are: (i) the stipulations on the panel of council, (ii) the recommendation letters issued by the panel of council, and (iii) procedures of investigation which. These were not governed in the Previous Health Law.
We also note that the Health Law expressly stipulates that the provisions relating to dispute settlement between health personnel and patients as well as the panel of council, are to be further governed by a Government Regulation.
Accordingly, the implementation of the above provisions remains to be seen. We also anticipate that, considering the objections from the medical society with respect to certain provisions of the Health Law, it is possible the Health Law to be challenged by the medical society or other parties of interest to the Constitutional Court. We will monitor the development and will issue further updates as relevant.
September 18, 2023
AKSET
Please contact Johannes C. Sahetapy-Engel (jsahetapyengel@aksetlaw.com), Raymont Travis (rtravis@aksetlaw.com), or Esther Christie E. Marpaung (emarpaung@aksetlaw.com) for further information.
Disclaimer:
The foregoing material is the property of AKSET and may not be used by any other party without prior written consent. The information herein is of general nature and should not be treated as legal advice, nor shall it be relied upon by any party for any circumstance. Specific legal advice should be sought by interested parties to address their particular circumstances.
Any links contained in this document are for informational purposes and are available and relevant at time this publication is made. We provide no liability whatsoever in respect of any information or content in such links.
Health Omnibus Law Series – Health Information System
This Newsflash is a part of our Health Omnibus Law Newsflash series, i.e., Law No. 17 of 2023 dated August 8, 2023, on Health (the “Health Law”). The Health Law governs a wide range of topics in the health sector, including health information systems (the “System”).
As previously noted, the Health Law was issued using the omnibus method. The Health Law revokes several laws and regulations in the health sector, including Law No. 36 of 2009 dated October 13, 2009 on Health.
♦ Key Definitions
Before we discuss the System, it is important to note the following definitions provided in the Health Law:
- System is defined as systems that integrate various stages of processing, reporting, and use of necessary information to increase the effectiveness and efficiency of health administration and directing actions or decisions that are useful in supporting health development;
- National System is defined as a System that is managed by the ministry which carries out government affairs in the health sector that integrates and standardizes all Systems in supporting health development.
♦ General Information on the System
Pursuant to Article 345(2) of the Health Law, the System shall be carried out by the (i) the Central Government, (ii) Regional Governments, (iii) health services facilities, and (iv) public community, whether an individual or an organization (collectively be referred to as the “Organizer”).
In this regard, Article 345(3) of the Health Law stipulates that the Organizer must integrate the System with the National System.
♦ Health Information Governance
Articles 346(3) and (4) of the Health Law provide that health information governance shall be carried out in accordance with the architecture of the System designed by the Minister of Health.
Based on Article 346(6) of the Health Law, the Organizer must conduct the data processing and health information in Indonesia. Article 347(1) of the Health Law stipulates that the Organizer is required to ensure the reliability of the System, which covers the (i) availability, (ii) security, (iii) maintenance, and (iv) integration.
Furthermore, Article 347(2) of the Health Law provides that the reliability of the System shall be conducted by way of (i) suitability of the system testing, (ii) maintaining the confidentiality of the data, (iii) determining data access rights policies, (iv) owning the system reliability certification, and (v) conducting regular audit.
In addition, Article 348(2) of the Health Law provides that the public shall be able to access public data and/or their own health data via the Organizer of a System that is integrated into the National System in accordance with the provisions of the prevailing laws and regulations.
Further, the Organizer must conduct the data processing and health information, which covers (i) planning, (ii) collection, (iii) storage, (iv) examination, (v) transfer, (vi) utilization, and (vii) demolishment.
According to Article 350(1) of the Health Law, the System shall contain data and information from (i) health services facilities, (ii) the Central Government and Regional Government Agencies, (iii) social security agencies, (iv) other agencies that engage in the health sector, (v) public community activities other than health service facilities, (vi) individual self-reporting, and (vii) other sources.
Article 351(1) of the Health Law provides that the Organizer of the System must ensure the data protection and health information of every individual.
Further, Article 351(2) of the Health Law stipulates that the data processing and health information that uses the health data of an individual must obtain an approval from the data owner and/or fulfill other provisions as the basis of the personal data processing in accordance with the prevailing laws and regulation in the personal data protection sector. This refers to Law No. 27 of 2022 on Personal Data Protection. Please click the following link for our newsflash on the Personal Data Protection Law: The Highly-Awaited Indonesian Personal Data Protection Law Is Passed.
An owner of the data is entitled to (i) obtain information with respect to the purpose of the collection of individual health data, (ii) access and rectify the data and information through the Organizer, (iii) request the Organizer to send his/her data to other Organizer, (iv) obtain the rights of other personal data subjects in accordance with the provisions of laws and regulations invitation in the field of personal data protection.
As mandated by Article 456 of the Health Law, all of the implementing regulations of the Health Law (including the ones relating to Systems) shall be issued at the latest 1 (one) year from the enactment of the Health Law.
September 14, 2023
AKSET
Please contact Johannes C. Sahetapy-Engel (jsahetapyengel@aksetlaw.com), Radiansyah S. Yamin (ryamin@aksetlaw.com), and M. Raehan A. Fadila (mfadila@aksetlaw.com) for further information.
Disclaimer:
The foregoing material is the property of AKSET and may not be used by any other party without prior written consent. The information herein is of general nature and should not be treated as legal advice, nor shall it be relied upon by any party for any circumstance. Specific legal advice should be sought by interested parties to address their particular circumstances.
Any links contained in this document are for informational purposes and are available and relevant at time this publication is made. We provide no liability whatsoever in respect of any information or content in such links.
Health Omnibus Law Series – Health Information System
Health Omnibus Law Series – Stipulation on Telemedicine Services
This Newsflash is a part of our Health Omnibus Law Newsflash series, i.e., Law No. 17 of 2023 dated August 8, 2023 on Health (the “Health Law”). The Health Law governs a wide range of topics in the health sector, including Telemedicine services as part of the services of a Health Service Facility.
As previously noted, the Health Law is issued using the omnibus method. The Health Law revokes several laws and regulations in the health sector, including Law No. 36 of 2009 dated October 13, 2009 on Health (the “Previous Health Law”).
Under the Previous Health Law, there were no provisions relating to Telemedicine services. Before the Health Law, Telemedicine services were regulated by the Minister of Health (the “MOH”) Regulation No. 20 of 2019 on the Organization of Telemedicine Services between Health Service Facilities (“Regulation 20/2019”).
With the issuance of the Health Law, Telemedicine services are now governed in a law rather than only in a Ministerial regulation.
Below, we set out the salient provisions of Telemedicine services under the Health Law.
♦ Recognition of Telemedicine
The implementation of health efforts in the form of health services may use information and communication technology through Telehealth and Telemedicine which are integrated with the National Health Information System.
The Telehealth service consists of providing clinical and non-clinical services, in which the clinical services are provided through Telemedicine.
♦ Provider of Telemedicine Services
Telemedicine services may be provided by all Health Service Facilities, as follows:
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- First-level Health Service Facilities, consisting of Public Health Centers (Pusat Kesehatan Masyarakat or Puskesmas), Primary Clinics (Klinik Pratama), and Private Practice of Medical (Praktik Mandiri Tenaga Medis) or Health Care Personnel (Tenaga Kesehatan);
- Advanced Health Service Facilities, consisting of Hospitals, Principal Clinics (Klinik Utama), Health Centers (Balai Kesehatan), and Private Practice of Medical (Praktik Mandiri Tenaga Medis) or Health Care Personnel (Tenaga Kesehatan); and
- Supporting Health Service Facilities.
In providing Telemedicine services, Health Service Facilities may independently provide such Telemedicine services or cooperate with a registered electronic system provider in accordance with the applicable laws and regulations.
Telemedicine services consist of Telemedicine services (i) between Health Service Facilities and (ii) between Health Service Facilities and public. The Telemedicine services provided by the Health Service Facilities shall be conducted by medical or health care personnel who have the relevant practice licenses. Please see our Newsflash on Licensing of Medical and Health Care Personnel: Health Omnibus Law Series – Simplification of Registration and Practice License for Medical and Health Care Personnels.
Further provisions in relation to the implementation of Telemedicine services will be further governed in a Government Regulation (Peraturan Pemerintah). We note from the Health Law that all implementing regulations (including the ones relating to Telemedicine services) shall be issued at least 1 (one) year from the enactment of the Health Law.
As of now, the Government Regulation which will stipulate further Telemedicine services, has yet to be issued. We will issue a continuation of this Newsflash once the Government Regulation relating to Telemedicine services has been issued.
August 31, 2023
AKSET
Please contact Johannes C. Sahetapy-Engel (jsahetapyengel@aksetlaw.com), Radiansyah S. Yamin (ryamin@aksetlaw.com), and Ammarsyarif G. Goenawan (agoenawan@aksetlaw.com) for further information.
Disclaimer:
The foregoing material is the property of AKSET and may not be used by any other party without prior written consent. The information herein is of general nature and should not be treated as legal advice, nor shall it be relied upon by any party for any circumstance. Specific legal advice should be sought by interested parties to address their particular circumstances.
Any links contained in this document are for informational purposes and are available and relevant at time this publication is made. We provide no liability whatsoever in respect of any information or content in such links.
Health Omnibus Law Series – Stipulation on Telemedicine Services
Health Omnibus Law Series – Simplification of Registration and Practice License for Medical and Health Care Personnels
This Newsflash is a part of our Health Omnibus Law, i.e., Law No. 17 of 2023 dated August 8, 2023 on Health (the “Health Law”). As noted in our previous Newsflashes, the Health Law is issued by way of the omnibus method and revokes several laws in the health sector, including Law No. 36 of 2009 dated October 13, 2009 on Health.
The Health Law governs a wide range of topics in the health sector. This Newsflash focuses on key provisions relating to the simplification of registration and practice licenses for medical and health care personnel.
♦ Elaboration on Medical Personnel and Health Care Personnel
Prior to the enactment of the Health Law and the issuance of the Constitutional Court Decision No. 82/PUU-XIII/2015 dated December 14, 2016 (the “Decision”), the terms “medical personnel” and “health care personnel” could be used interchangeably since the previous regulatory regime did not specifically define the term “medical personnel” and before the issuance of the Decision, medical personnel were categorized under health care personnel.
As a background, under the General Elucidation of Law No. 29 of 2004 dated October 6, 2005 on Medical Practice as partially revoked by Law No. 36 of 2014 dated October 17, 2014 on Health Care Personnel (collectively, “Law 29/2004”), it could be interpreted that medical personnel consisted of doctors and dentists since they were personnel that were authorized to take medical actions on patients based on their relevant competence. Meanwhile, referring to Article 11(1) of Law No. 36 of 2014 dated October 17, 2014 on Health Care Personnel (“Law 36/2014”) before the issuance of the Decision, health care personnel consisted of medical personnel, clinical psychologists, nurses, midwives, pharmacists, public health workers, environmental health workers, nutritionists, physical therapists, medical technicians, biomedical engineering personnels, traditional health workers, and others. Therefore, this caused the public to interchangeably use those two terms.
After the issuance of the Decision, medical personnel were no longer included under health care personnel. However, the then-regulation did not provide a clear definition of the term “medical personnel”.
Now, with the enactment of the Health Law, these two terms (i.e., medical personnel and health care personnel) are now clearly distinguished and defined. Under the Health Law, medical personnel are persons who devote themselves to the health sector and possess a professional attitude, knowledge, and skills through education in the medical or dentistry profession which requires the authorization to conduct health attempts. Meanwhile, the definition of health care personnel is nearly identical, but their professional attitude, knowledge, and skills are obtained through a higher education (pendidikan tinggi), not through education in the medical or dentistry profession. Furthermore, Articles 198 and 199(1) of the Health Law elaborate that the term “medical personnel” covers doctors and dentists, including the specialists and subspecialists; while the term “health care personnel” covers the same types of personnel described under Law 36/2014 following the issuance of the Decision.
♦ Practice Licenses for Medical Personnel and Health Care Personnel
To be able to practice in the health services sector, medical and health care personnel are required to obtain a registration certificate (Surat Tanda Registrasi or an “STR”) and a practice license (Surat Izin Praktik or an “SIP”). Under the previous regime (i.e., Law 29/2004 and Law 36/2014), medical and health care personnels had to fulfill the following requirements to obtain an STR:
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- Possession of a medical or dentistry degree (for medical personnel) or a degree in health education (for health care personnel);
- a statement letter to state that the person had taken the profession’s oath;
- a certificate stating the person has sound mental and physical health;
- a competency or professional certificate; and
- a statement of compliance with the provisions of professional ethics.
The STR was issued by the relevant health council and was valid for five years.
In addition to the STR, the previous regime also stipulated that to obtain an SIP, medical and health care personnels had to satisfy the following conditions:
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- Possession of a valid STR;
- a place of practice; and
- a recommendation from the relevant professional organization.
An SIP was issued by the health officials of the regency/city where the practice was held and would be valid subject to the validity of the STR and whether the place of practice would still be in accordance with the SIP. Furthermore, Law 29/2004 limited medical personnel to conduct practice in a maximum of only three places based on its SIP.
With the enactment of the Health Law, the requirements for obtaining an STR and an SIP are simplified. Articles 260(3) and (4) of the Health Law regulate that the prerequisites for obtaining an STR are at least the following: (i) possession of a degree in health education and/or professional certificate; and (ii) a competency certificate. As such, the Health Law removes the prerequisite for an STR to obtain a statement letter providing a person has taken the profession’s oath and a certificate stating a person had sound mental and physical health.
As for obtaining an SIP, according to Article 264(1) of the Health Law, medical and health care personnel now must satisfy the following conditions: (i) owns the STR; and (ii) owns a place of practice. Therefore, removing the need to obtain a recommendation letter from the relevant professional organization.
Besides the simplification in obtaining an STR and an SIP, other notable changes introduced by the Health Law in relation to the STR and the SIP are: (i) an STR now does not have an expiry date, its validity shall end if the related personnel passes away, it is inactivated by the health council, or revoked based on a final and binding court decision; (ii) an SIP is now valid for five years; and (iii) the Health Law does not regulate a provision that limits a maximum of three places for a medical personnel’s place of practice based on its SIP.
Since the Health Law stipulates that further provisions of STR and SIP will be further regulated in a Government Regulation, we will monitor the development and will issue further updates as relevant.
August 30, 2023
AKSET
Please contact Johannes C. Sahetapy-Engel (jsahetapyengel@aksetlaw.com), Adhitya Ramadhan (aramadhan@aksetlaw.com) or Ayu Nandini Prameswari (aprameswari@aksetlaw.com) for further information.
Disclaimer:
The foregoing material is the property of AKSET and may not be used by any other party without prior written consent. The information herein is of general nature and should not be treated as legal advice, nor shall it be relied upon by any party for any circumstance. Specific legal advice should be sought by interested parties to address their particular circumstances.
Any links contained in this document are for informational purposes and are available and relevant at time this publication is made. We provide no liability whatsoever in respect of any information or content in such links.
Health Omnibus Law Series – Data Privacy in the Health Sector
This Newsflash is a part of our Health Omnibus Law Newsflash series with respect to the issuance of Law No. 17 of 2023 dated August 8, 2023 on Health (the “Health Law”). The Health Law governs a wide range of topics in the health sector including the personal data protection in the health sector as well as to harmonize the aspects of personal data protection in the health industry to be in line with the applicable data protection laws and regulations, particularly Law No. 27 of 2022 dated October 17, 2022 on Personal Data Protection (the “PDP Law”). Please refer to our previous Newsflash on the PDP Law at the following link: AKSET Newsflash - PDP Law.
As previously noted, the Health Law is issued using the omnibus method. The Health Law revokes several laws and regulations in the health sector, including Law No. 36 of 2009 dated October 13, 2009 on Health (the “Previous Health Law”). Under the Previous Health Law, provisions relating to data privacy and/or personal data protection were inadequate and were still found sporadically in several implementing regulations under the Previous Health Law, including the Minister of Health Regulation No. 24 of 2022 dated August 31, 2022 on Medical Records. Although the Health Law revokes the Previous Health Law, all implementing regulations of the Previous Health Law remain valid for so long they do not contradict the Health Law.
We highlight the key data privacy related provisions under the Health Law, as follows.
♦ Personal Health Data and Information
- Obligation for Medical Personnel, Health Personnel, and Health Service Facilities to Maintain Confidentiality of Patients’ Personal Health Data and Information
Each Medical Personnel or Tenaga Medis (i.e., doctors and dentists) and Health Personnel or Tenaga Kesehatan (e.g., nurses) must maintain confidentiality of patients’ personal health in providing medical services to individuals. Information on patients’ personal health that shall be kept confidential includes history, condition and treatment, medication for one’s physical and psychological health, as well as the patients’ personal data. Such obligation also applies to Health Service Facilities or Fasilitas Pelayanan Kesehatan.
- Acknowledgement of Patients’ Rights to Confidentiality of Personal Health Data and Information and to Obtain Personal Health Data and Information
Patients are entitled to, among others, the right to obtain confidentiality of personal health data dan information. Further, a patient is entitled to request their personal health, including actions and treatments that a patient has received or will receive from Medical Personnel and/or Health Personnel.
However, the confidentiality above is not applicable in certain conditions such as (i) fulfillment of requests by law enforcers for law enforcement, (ii) management of extraordinary events or kejadian luar biasa, outbreaks, or disasters, (iii) limited educational and research interests, (iv) efforts to protect against threats to the safety of others, individually or to the public, (v) health maintenance, treatment, healing, and patient care interests, (vi) the patient’s own request, (vii) administrative, insurance payments, or health financing security interests, and/or (viii) other interests as regulated in the applicable laws and regulations.
♦ Medical Records
- Obligation for Medical Personnel, Health Personnel, and Health Service Facilities to Maintain Confidentiality of Medical Records
In providing medical services to individuals, each Medical Personnel and Health Personnel shall maintain a medical record prepared using an electronic system. A medical record is defined as a document that contains the patients’ identity data, observation, treatment, action, and other services provided to the patients. Such medical records shall be maintained and kept confidential by the Medical Personnel, Health Personnel, and management of Health Service Facilities.
- Acknowledgement of Patients’ Rights to Access Medical Records
Although the medical records are owned by the Health Service Facility, a patient may access information contained in their medical records. The Health Service Facility has the obligation to maintain the security, integrity, confidentiality, and availability of the data contained in the medical records.
- Management of National Health Data
In the context of the management of national health data, the Minister of Health (the “MOH”) is responsible for the management of the medical records. Such management of medical records includes formulation of policies, collection, processing, storage, security, data transfer, and monitoring.
- Operation of Health Information System
To carry out effective and efficient health efforts, the Health Law governs the operation of a Health Information System, which is a system that integrates multiple stages of processing, reporting, and use of information to increase effectiveness and efficiency in health management and directing decision making for health development. The operators of such Health Information System may be the Central Government, a Regional Government, a Health Service Facility, and the public, both individuals and groups (any one of them, an “Operator”).
- Obligation of Operators in Processing of Health Data and Information
An Operator shall ensure the reliability of the Health Information System which covers (i) availability, (ii) security, (iii) maintenance, and (iv) integration. Further, an Operator shall carry out the processing of health data and information in accordance with the applicable laws and regulations which includes (i) planning, (ii) collection, (iii) storage, (iv) inspection, (v) transfer, (vi) utilization, and (vii) destruction.
In carrying out the processing of health data and information, an Operator shall ensure the protection of health data and information of each individual. The Health Law also emphasizes that the processing of health data and information that uses individuals’ health data is subject to consent from the data owners and/or fulfill other requirements as the basis of personal data processing in accordance with laws and regulations on personal data protection.
- Rights of Data Owners in Processing of Health Data and Information
In relation to the data processing by an Operator, the data owners are entitled to, as follows: (i) obtain information regarding the purpose of collecting the individual health data, (ii) access and make changes to the data and information through the Operator, (iii) request the Operator to send the data to another Operator, (iv) request the Operator to delete incorrect data based on the data owner’s consent, and (v) obtain other appropriate personal data subject rights in accordance with laws and regulations on personal data protection.
- Location for Processing of Health Data and Information
An Operator shall carry out the processing of health data and information within Indonesia. Such processing of health data and information includes (i) acquisition and collection, (ii) management and analysis, (iii) storage, (iv) repairs and updates, (v) appearance, announcement, transfer, distribution, or disclosure, and/or (vi) deletion or destruction.
Notwithstanding the above, the Health Law provides that data processing may be carried out outside the territory of Indonesia (in the form of transfer and storage) in accordance with laws and regulations regarding electronic information and transactions, electronic system operation, and personal data protection. Specifically for cross-border data transfers, such data transfers shall be for a specific and limited purpose with a permit from the President.
We note that the Health Law expressly stipulates that provisions relating to medical records and processing of health data and information are to be further governed by a Government Regulation. As a reference, the same also applies to the majority of the provisions stipulated under the Health Law, which will be further governed by Presidential Regulations, Government Regulations, and Minister of Health Regulations.
Considering the current objections from medical society with respect to certain provisions under the Health Law, kindly anticipate that there is a possibility for the Health Law to be challenged by the medical society or other parties of interest through the Constitutional Court. We will monitor the development and will issue further updates as relevant.
August 24, 2023
AKSET
Please contact Johannes C. Sahetapy-Engel (jsahetapyengel@aksetlaw.com), Clara Anastasia So (canastasia@aksetlaw.com), or M. Fatih Satria Kasmaliputra (mkasmaliputra@aksetlaw.com) for further information.
Disclaimer:
The foregoing material is the property of AKSET and may not be used by any other party without prior written consent. The information herein is of general nature and should not be treated as legal advice, nor shall it be relied upon by any party for any circumstance. Specific legal advice should be sought by interested parties to address their particular circumstances.
Any links contained in this document are for informational purposes and are available and relevant at time this publication is made. We provide no liability whatsoever in respect of any information or content in such links.
Health Omnibus Law Series – Data Privacy in the Health Sector
Health Omnibus Law Series – Occupational Health in Workplace
This Newsflash is part of our Health Omnibus Law Newsflash series with respect to the issuance of Law No. 17 of 2023 dated August 8, 2023 on Health (the “Health Law”). As noted in our previous Newsflash, the Health Law is issued using an omnibus method, revoking several laws and regulations in the health sector, including Law No. 36 of 2009 dated October 13, 2009 on Health (the “Previous Health Law”).
The Health Law governs a wide range of topics in the health sector. This Newsflash focuses on key provisions relating to occupational health in workplace, as follows.
♦ Obligation for All Parties to Participate in Health Security Program
The Health Law stipulates the rights and obligations in relation to the health sector that shall be complied with by all parties (i.e., individuals and corporations). Among others, the Health Law requires that all parties to participate in the health security program in the national security system (i.e., the Health Social Security administered by Badan Penyelenggara Jaminan Sosial Kesehatan) in accordance with the applicable laws and regulations.
We note that the above obligation is in line with the provisions of Law No. 24 of 2011 dated November 25, 2011 on Social Security Administration Agencies as amended by Law No. 6 of 2023 dated March 31, 2023 on Stipulation of Government Regulation No. 2 of 2022 on Job Creation into Law.
♦ Obligation for Employers to Maintain Occupational Health in Workplace
In essence, the responsibility to maintain occupational health falls on the Central Government, Regional Governments, employers, and administrators or managers of workplaces. Such occupational health efforts (or in Indonesian, upaya kesehatan kerja) shall be carried out in conjunction with the occupational health and safety system for the purpose of improving knowledge, awareness, ability of live a health life and prevent sickness caused by work and work accidents, as well as health problems and bad effects caused by work.
Occupational health efforts shall be carried out in workplaces, both the formal and informal sectors, as well as the Health Service Facilities in accordance with occupational health standards. Further, employers and administrators or managers of workplaces shall comply with the occupational health standards and ensure a healthy working environment. Employers and administrators or managers of workplaces shall be responsible for work accidents in workplaces and sickness caused by work.
To ensure the health of employees, employers are required to carry out the promotive, preventive, curative, rehabilitative, and palliative efforts and bear all health care costs of the employees. Employers are also required to bear costs for work-related sickness, health issues, and injuries caused by work suffered by employees in accordance with the applicable laws and regulations. Similarly, the Central Government and Regional Governments shall provide support for the protection of the employees.
On the other hand, employees and all parties in a workplace are required to create and maintain a healthy working environment and comply with occupational health and safety regulations applicable in the workplace.
We note that generally the above provisions are similar to those of the occupational health governed under the Previous Health Law. We also note that the Health Law expressly stipulates that the provisions relating to occupational health are to be further governed by a Government Regulation.
Accordingly, the implementation of the above provisions relating to occupational health remains to be seen. We also anticipate that, considering the objections from the medical society with respect to certain provisions of the Health Law, it is possible the Health Law to be challenged by the medical society or other parties of interest to the Constitutional Court. We will monitor the development and will issue further updates as relevant.
August 24, 2023
AKSET
Please contact Johannes C. Sahetapy-Engel (jsahetapyengel@aksetlaw.com), Thomas P. Wijaya (twijaya@aksetlaw.com), or M. Fatih Satria Kasmaliputra (mkasmaliputra@aksetlaw.com) for further information.
Disclaimer:
The foregoing material is the property of AKSET and may not be used by any other party without prior written consent. The information herein is of general nature and should not be treated as legal advice, nor shall it be relied upon by any party for any circumstance. Specific legal advice should be sought by interested parties to address their particular circumstances.
Any links contained in this document are for informational purposes and are available and relevant at time this publication is made. We provide no liability whatsoever in respect of any information or content in such links.
Health Omnibus Law Series – Occupational Health in Workplace
Health Omnibus Law Series – General Overview
After long discussions within the House of Representatives and objections from the medical society, the Government finally issued Law No. 17 of 2023 dated August 8, 2023 on Health (the “Health Law”). The Health Law is over 200 pages and contains 20 chapters and 458 Articles. The Health Law took effect as of August 8, 2023.
The Health Law is an omnibus law. In other words, the Health Law revokes and combines a significant number of existing laws and regulations in the health sector, among others: (i) Law No. 29 of 2004 dated October 6, 2004, but entered into force on October 6, 2005 on Medical Practice, (ii) Law No. 36 of 2009 dated October 13, 2009 on Health, (iii) Law No. 44 of 2009 dated October 28, 2009 on Hospital, and (iv) Law No. 20 of 2013 dated August 6, 2013 on Medical Education. It is also worth noting that the Health Law expressly stipulates that the implementing regulations of the laws revoked by the Health Law remain valid for so long they do not contradict with the provisions of the Health Law.
We understand that the issuance of the Health Law is related to the Covid-19 pandemic event which brought awareness to the importance of strengthening Indonesia’s national health system and the need to carry out a thorough transformation to Indonesia’s national health system as an effort to improve Indonesia’s public health as well as increasing Indonesia’s competitiveness as a nation.
The Health Law contains provisions that support the implementation of the transformation of Indonesia’s health system, among others, (i) synchronization of health management carried out by the Central Government, Regional Governments, and/or the public, (ii) strengthening the implementation of health efforts in the form of promotive, preventive, curative, rehabilitative, and/or palliative, by prioritizing public rights and government responsibilities, (iii) equal distribution of the Health Service Facilities (in Indonesian, Fasilitas Pelayanan Kesehatan) for easy access for the public through the development of the Health Service Facilities, (iv) availability of Medical Personnel (in Indonesian, Tenaga Medis) and Health Personnel (in Indonesian, Tenaga Kesehatan) through increased implementation of specialist/sub-specialist education, transparency in the registration and licensing process, and improvements in the mechanism of accepting Indonesian overseas graduate Medical Personnel and Health Personnel through transparent competency test, and (v) strengthening of Health Information System (in Indonesian, Sistem Informasi Kesehatan) through the Government’s authority to manage and use health data through integration of multiple Health Information Systems to the National Health Information System.
Provisions on the majority of matters governed under the Health Law are to be further governed under its implementing regulations, i.e., Presidential Regulations, Government Regulations, and Minister of Health Regulations. We also anticipate that, considering the objections from the medical society with respect to certain provisions of the Health Law, it is possible the Health Law to be challenged by the medical society or other parties of interest to the Constitutional Court. We will monitor the development and will issue further updates as relevant.
We will also continue to review the changes and additions regulated under the Health Law and shall circulate follow-up newsflashes in due course.
August 24, 2023
AKSET
Please contact Johannes C. Sahetapy-Engel (jsahetapyengel@aksetlaw.com), Thomas P. Wijaya (twijaya@aksetlaw.com), or M. Fatih Satria Kasmaliputra (mkasmaliputra@aksetlaw.com) for further information.
Disclaimer:
The foregoing material is the property of AKSET and may not be used by any other party without prior written consent. The information herein is of general nature and should not be treated as legal advice, nor shall it be relied upon by any party for any circumstance. Specific legal advice should be sought by interested parties to address their particular circumstances.
Any links contained in this document are for informational purposes and are available and relevant at time this publication is made. We provide no liability whatsoever in respect of any information or content in such links.