On 29 April this year, the Indonesian Medical Council (Konsil Kedokteran Indonesia) ("KKI") issued KKI Regulation No. 74 of 2020 on Clinical Authorities and Medical Treatment Through Telemedicine During the COVID-19 Pandemic ("KKI Regulation 74").
The telemedicine sector has never been rigidly regulated in Indonesia, despite growing numbers of business players and huge potentiality. There is always a debate on the ethicality of providing healthcare services remotely. Much of the doubt goes to the accuracy of providing full diagnosis through remote consultation without full physical check.
As part of the government's Industry Revolution 4.0 agenda, the Ministry of Health ("MOH") principally supports the growth of telemedicine and encourages healthcare service providers to begin adopting telemedicine model in giving healthcare services to patients. In reality, the MOH has not reflected this attitude in a concrete written legislative document and rather entrust medical associations with providing the guideline.
- Key Takeaways
- In depth
- Telemedicine Services under KKI Regulation 74
- Pre-Requisite to Provide Telemedicine Services
- Key Takeaways of Telemedicine Services under KKI Regulation 74
- Clinical Authority on COVID-19 Medical Treatment
- Relevant Sanctions
The key development associated with KKI Regulation 74 is that it provides a legal basis and permission for doctors and dentists to provide healthcare services through electronic system platforms (commonly known as telemedicine).
KKI Regulation 74 came into effect on 30 April 2020, but will only remain in effect until the Indonesian government officially declares the end of the COVID-19 state of public health emergency. Business actors in the hospital or healthcare business should see KKI Regulation 74 as 'temporary permission' for doctors and dentists to provide healthcare services remotely. It should not be seen as an indication of the authorities' long term view on telemedicine.
While KKI Regulation 74 does not clearly regulate any sanctions, business actors must consider other relevant sanctions provided under the prevailing laws and regulations that could be applicable if KKI Regulation 74 is violated. We will discuss these in further detail below.
Telemedicine Services under KKI Regulation 74
Other than direct medical treatments (onsite medical treatments), KKI Regulation 74 clarifies that doctors and dentists are allowed to provide telemedicine services through applications/electronic systems. Telemedicine services under KKI Regulation 74 means consultation or teleconsultation services in the form of writing, voice and/or video to diagnose, treat and cure patients.
Pre-Requisite to Provide Telemedicine Services
KKI Regulation 74 requires doctors and dentists who intend to provide medical treatment through telemedicine services to have a registration letter (Surat Tanda Registrasi or STR) and practice permit (surat izin praktik or SIP) at their healthcare facility.
Key Takeaways of Telemedicine Services under KKI Regulation 74
- In emergency situations, doctors and dentists who provide medical treatment through telemedicine services must instruct their patients to undergo direct (read: physical) medical treatment at the relevant healthcare facility.
- Patients must provide their general/informed consent in accordance with the prevailing laws and regulations. KKI Regulation 74 does not elaborate on the context of the general/informed consent1. In any case, this requirement must be read in conjunction with medical confidentiality principles. Any medical data of the patients collected through the telemedicine platform would also be subject to the prevailing personal data protection rule. Business actors need to consider gaining patients' consent for the use of their medical data along with the general/informed consent if this is intended.
- Doctors and dentists who provide medical treatment through telemedicine services must provide a medical record for every patient and archive it at the healthcare facility in accordance with the prevailing laws and regulations. The medical record may be in written or electronic form and may be provided to patients in the form of a transcript but the original one must be kept at the healthcare facility where the doctors and dentists are registered.
- Doctors and dentists may provide a diagnosis (through telemedicine) and subject the patient to supporting medical examination procedures in the form of:
- radio image
- drugs prescription (except narcotics and psychotropic) and/or medical devices
- explanation letter (surat sakit)
- Telemedicine services that can be provided by doctors and dentists are subject to some limitations. Below are the actions that doctors and dentists are prohibited to do in providing healthcare services through telemedicine:
- conduct teleconsultation with patients without any involvement of a healthcare facility2
- provide misleading, non-ethical and inadequate information and/or explanation to patients and/or their families
- diagnose and treat patients outside of their competence
- require patients to conduct unnecessary additional medical assessments
- conduct immoral, intimidating and reprehensible actions against the patients
- conduct invasive actions through teleconsultation
- impose additional costs outside costs settled by the healthcare facility
- provide a letter of healthiness (surat keterangan sehat)
- Doctors and dentists who provide medical treatment through telemedicine services may receive payment as determined by the healthcare facility they are registered to in accordance with the prevailing laws and regulations. This implies that any payment for the telemedicine service (through a payment platform or otherwise) must observe the internal rule of the healthcare facility where the doctors or dentists are registered, and direct payment to the doctors and dentists providing the services might not be possible.
Clinical Authority on COVID-19 Medical Treatment
Other than regulating the provision of telemedicine services, KKI Regulation 74 also sets out the clinical authority (i.e., doctor-in-charge) in the provision of COVID-19 medical treatment in healthcare facilities.
Article 6 of Regulation 74 states that doctors, specialist doctors and subspecialist doctors can be in charge of providing COVID-19 medical treatment in the healthcare facility where they are registered, based on their relevant competency. Severe cases that must be treated in an Intensive Care Unit (ICU) must be referred to specialist and/or subspecialist doctors depending on their competency. In case of overabundance of severe COVID-19 related cases, internists and/or paediatrics can take up the role as the doctor-in-charge who has the clinical authority to provide COVID-19 related care, with due observance of the prevailing clinical authority limitations in the relevant hospital.
The above implies that treatment of COVID-19 is not expected to be limited to a select few hospitals that are designated as COVID-19 hospitals.
Relevant Sanctions for HCP
KKI Regulation 74 does not elaborate on the relevant sanction that could be imposed on healthcare professionals (read: doctors and dentists) if they violate KKI Regulation 74. However, to understand the real implications of KKI Regulation 74, we need to see the bigger picture and see whether there is any other applicable sanction under the prevailing laws and regulations that could be relevant to healthcare professionals or business actors in relation to the provision of telemedicine services that is contrary to KKI Regulation 74, i.e., other sanctions established under other laws and regulations.
As one of the basic principles in providing medical treatments for patients, Article 10 of the Medical Code of Ethics (Kode Etik Kedokteran) states that every doctor must be sincere and use his/her best knowledge and skills for the interests of the patients. If the doctor is not able to treat or cure his/her patients, the doctor must provide a reference to other doctors who are capable of treating the disease.
In this context, Article 66 of Law No. 36 of 2014 on Healthcare Professionals ("HCP Law") states that every healthcare professional must implement its compliance practice and fulfill the professional standards, professional services standards and operational procedures standards. To be more specific, KKI Regulation No. 4 of 2012 on Professional Discipline for Doctors and Dentists regulates that there are 28 forms of actions classified as non-compliance that could subject doctors and dentists to sanctions that will be imposed by KKI. The imposition of sanction is further regulated in KKI Regulation No. 43 of 2016 on the Guidelines of the Enforcement of Administrative Sanctions.
Article 49 of the HCP Law generally regulates that any noncompliance action of a healthcare professional may be subject to sanctions by KKI in the form of:
- a written warning
- recommendation on the revocation of a registration letter ("STR") or Surat Izin Praktik ("SIP")
- requiring the healthcare professional to participate in training or a workshop at a healthcare educational institution
There are also other criminal sanctions that can be imposed on healthcare professionals in certain conditions under the laws and regulations.
The supervisory authority for the STR and SIP is different. Healthcare professional councils (e.g., KKI) administer and supervise the STRs, and regional governments administer and supervise the SIPs. The HCP Law regulates that an STR serves as the prerequisite of an SIP. So, KKI has more authority to sanction the relevant healthcare professionals in the provision of telemedicine services.
Relevant Sanctions for Electronic System Operators
Due to its nature, telemedicine services are operated through electronic system platforms. However, it is unclear whether KKI Regulation 74 is connected with Ministry of Trade Regulation No. 50 of 2020 on the Provisions on Business Licensing, Advertisements, Development and Supervision of Business Actors in Electronic Systems Trading ("MOT Regulation 50"). It remains to be seen whether the government would consider the provision of telemedicine services as "trading" activity and subject to requirements set out in MOT Regulation 50. You can find our previous client on the issuance MOT Regulation 50 here.
Accordingly, it remains to be seen whether a telemedicine electronic system operator will be subject to a sanction due to violation of KKI Regulation 74. However, under Government Regulation No. 24 of 2018 on the Online Single Submission system ("OSS"), the OSS agency (i.e., BKPM) may impose administrative sanctions on business actors that, among other things, fail to comply with laws and regulations. We have seen the OSS agency sending an electronic reprimand to a company for its breach of the foreign investment restriction. Under that reprimand, the company was required to rectify its noncompliance within 30 days after the date of the electronic letter.
The general sanctions are:
- electronic or written reprimand (the relevant business entity must provide its written responses and follow-up actions in relation to the letter at the latest 30 calendar days after the date of the letter)
- restriction of business activities
- suspension of business activities and/or investment facilities
- revocation of business activities and/or investment permit and/or investment facilities