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Highlight of The Indonesia's New Medical Records Regulation

Author: John Raoul Adithya, Mon, Oct 10th 2022, 13:09

HIGHLIGHT OF THE INDONESIA’S NEW MEDICAL RECORDS REGULATION

A. INTRODUCTION

The Minister of Health of the Republic of Indonesia has issued a Regulation of the Minister of Health Number 24 of 2022 regarding the Medical Records (“Permenkes 24/2022”) which is effective  on August 31, 2022. The purpose of issuing the Permenkes 24/2022 is to (a) improve the quality of health services; (b) provide legal certainty in the administration and management of medical records; (c) ensure the security, confidentiality, integrity, and availability of medical record data; and (d) realize the implementation and management of medical records that are digitally based and integrated.[1]

The previous  Regulation of the Minister of Health Number 269/MENKES/PER/III/2008 on Medical Records (“Permenkes 269/2008”) was revoked as it is no longer in line with the development of science and technology, the needs of health service and community.[2] Permenkes 24/2022 also regulates the transition period that all health service facilities must hold electronic medical records in accordance with Permenkes 24/2022 no later than December 31, 2023.[3] . This article will highlight several provision on Permenkes 24/2022

B. DISCUSSION

1. Medical Records

The fundamental difference between Permenkes 24/2022 with the previous arrangement is the presence of electronic elements in medical records. Definitively, a medical record is a document that contains data on the patient's identity, examination, treatment, actions, and other services that have been provided to the patient (“Medical Record”).[4] Meanwhile, an electronic Medical Record is a Medical Record created with electronic system intended for the implementation of a Medical Record (“Electronic Medical Record”).[5] The Electronic System is a series of electronic devices and procedures that function to prepare, collect, process, analyze, store, display, announce, transmit, and/or disseminate electronic information (“Electronic System”).[6] Health Service Facility is a tool and/or place used to organize health service efforts, both promotive, preventive, curative, and rehabilitative carried out by the government, local government, and/or the community (“Health Service Facility”).[7]

2. Ownership of Documents and Contents of Medical Records and/or Electronic Medical Records

a. Document Ownership and Contents of Medical Records

To find out about the ownership of Medical Records, it must first be understood that Permenkes 24/2022 distinguishes arrangements regarding ownership of medical records “documents” and ownership of the "contents" of Medical Records.

The Medical Record’s document belongs to the Health Service Facility.[8] While, the ownership of the contents of the Medical Record belongs to the patient.[9] In its arrangement, the contents of such Medical Records must be provided to the patient.[10] The contents of the Medical Record can also be provided to the closest family or other parties.[11] The contents of the Medical Record submitted by the patient at least consist of the patient's identity, the results of the physical and supporting examination, diagnosis, treatment, and follow-up plan for health services and the name and signature of the health worker providing the health service.[12]

b. Electronic Medical Records

The contents of the Electronic Medical Record consist of:[13] (1) administrative documentation, which contains registration documents; and (2) clinical documentation, which contains all documentation of health services provided to patients in Health Care Facilities. Health Service Facilities can develop the contents of Electronic Medical Records in accordance with the needs of health services. Further provisions regarding the contents of electronic medical records are set out in the Electronic Medical Record guidelines.[14] Health Care Facilities must open access to all contents of the Patient's Electronic Medical Record to the Ministry of Health.[15] The Ministry of Health is authorized to utilize and store the contents of electronic medical records in the context of processing health data.[16]

3. Electronic System Maintenance

In Permenkes 24/2022, the Minister of Health facilitates the implementation of Electronic Medical Records in Health Service Facilities.[17] Facilitation includes the provision of: (a) Electronic Systems in the operation of Electronic Medical Records; and (b) service platforms and standards for interoperability and health data integration.[18] In order to facilitate, the Minister of Health will coordinate with relevant ministries/agencies.[19]

Electronic Systems in the implementation of Electronic Medical Records can be in the form of Electronic Systems developed by Ministry of Health, Health Care Facilities themselves; or though cooperation with a registered Electronic System Operator ("PSE") .

In the event that the PSE is not registered as regulated by regulations in the field of communication and information, then based on Government Regulation Number 71 of 2019 concerning the Implementation of Electronic Systems and Transactions (“PP 71/2019”) will be subject to administrative sanctions.

4. Electronic Medical Record Storage

In Permenkes 24/2022, the storage of medical records that are regulated is only addressed to Electronic Medical Records. Where electronic medical record storage is an activity of storing Medical Record data on digital-based storage media at Health Service Facilities.[20] It should be noted that Electronic Medical Records stored by Health Care Facilities must be connected/interoperable with the interoperability and health data integration service platform managed by the Ministry of Health.[21] The Health Service Facility can cooperate with the Electronic System Operator (“PSE”) which has data storage facilities in the country.[22] PSE is prohibited from opening, taking, manipulating, damaging, utilizing data, and other things that harm Health Care Facilities.[23]

The period of storage of Electronic Medical Record data at a Health Service Facility is carried out at least 25 (twenty-five) years from the date of the patient's last visit. [24] In the event that it has exceeded the storage time limit, the Electronic Medical Record data may be excluded from being destroyed if the data is still to be used or utilized.[25]

5. Disclosure of Contents of the Medical Record

The disclosure  of the contents of the Medical Record must be done in writing or electronically and carried out on a limited basis as needed.[26] There are 2 (two) types of unveil the contents of the Medical Record which are regulated in permenkes 24/2022, namely as follows:[27]

a. Disclosure contents of the Medical Record with the consent of the patient

The disclosure of the contents of the Medical Record with the consent of the patient is carried out to:[28]

  • the interests of health maintenance, treatment,
  • healing, and patient care;
  • the patient's own requests; and/or
  • administrative needs, insurance payments or health financing guarantees.

The request for the disclosure of the contents of the Medical Record was submitted to the leadership of the Health Service Facility.[29] If the patient is incapacitated, then approval for the disclosure of the contents of the Medical Record can be given by the closest family or custodian in accordance with the provisions of the laws and regulations.[30] In addition to the immediate family, the approval of the disclosure  of the contents of the Record can be done by the heirs.[31] In the event that the closest family and heirs cannot give consent because of unknown whereabouts, legally incapable, deceased, or absent, then consent is not required.[32]

b. Disclosure of the contents of the Medical Record without the patient's consent

The disclosure of the contents of the Medical Record not with the approval of the Patient is carried out based on the provisions of the laws and regulations, for the purposes of: anycircumtances as listed in Article 35 paragraph (1) Permenkes 24/2022.

The disclosure of the contents of the Medical Record without the consent of this patient is carried out without revealing the identity of the patient.[33]

Please note that although this opening does not require the patient's approval, the disclosure of the contents of this Medical Record must obtain written approval from the Minister of Health.[34] Based on the approval, the authorized party or institution submits an opening request to the head of the Health Service Facility.[35] Approval from the Minister is excluded for the disclosure of the contents of the Medical Record which is carried out on the basis of a court order, and may be made by providing a copy of the Medical Record document and/or showing the original document.[36]

Apart from a court order, ministerial approval is excluded if the unveiling of the contents of the Medical Record is for the purpose of due to some events as listed in Article 37[37].

C. CONCLUSION

Based on the exposure to the above material can be concluded as follows:

  1. The Medical Record document belongs to the Health Service Facility, while the contents of the Medical Record belong to the patient.
  2. Health Service Facilities are required to organize an Electronic System to store Electronic Data Records. Where this implementation can be carried out with 3 (three) options: (a) the electronic system of the Ministry of Health through a written application; (b) the Health Care Facility itself; and (c) PSE through cooperation, where the PSE must have a recommendation from the Minister of Health and be registered as a PSE based on PP 71/2019.
  3. The period of retention of electronic medical records is at least 25 (twenty-five) years from the date of the patient's last visit. If the period of time has been exceeded, then the Health Service Facility can destroy or continue to store it for use or use.
  4. The disclosure of the contents of the Medical Record consists of the following 2 (two) types,  (1) Opening of the medical record without the patient's consent, intended for the benefit of the patient; and (2) The opening of medical records without the patient's consent, is for um purposes including research and education. If the disclosure is due to  order of a court, the handling of extraordinary events such as outbreaks, or efforts to protect against safety hazards individually or in the community, in the case of the absent of patient’s approval, it is exempted to obtain an approval from the Minister of Health.

 

[1] Article 2 Permenkes 24/2022.

[2] Article 46 Permenkas 24/2022.

[3] Article 45 Permenkes 24/2022.

[4] Article 1 Number 1 Permenkes 24/2022.

[5] Article 1 Number 2 Permenkes 24/2022.

[6] Article 1 Number 7 Permenkes 24/2022.

[7] Article 1 Number 5 Permenkes 24/2022.

[8] Article 25 paragraph (1) Permenkes 24/2022.

[9] Article 26 paragraph (1) Permenkes 24/2022.

[10] Article 26 paragraph (2) Permenkes 24/2022.

[11] Article 26 paragraph (3) Permenkes 24/2022.

[12] Article 26 paragraph (6) Permenkes 24/2022.

[13] Article 27 paragraph (1) Permenkes 24/2022

[14] Article 27 paragraph (2) Permenkes 24/2022.

[15] Article 27 paragraph (3) Permenkes 24/2022.

[16] Article 28 paragraph (1) Permenkes 24/2022.

[17] Article 8 paragraph (1) Permenkes 24/2022.

[18] Article 8 paragraph (2) Permenkes 24/2022.

[19] Article 8 paragraph (3) Permenkes 24/2022.

[20] Article 20 paragraph (1) Permenkes 24/2022.

[21] Article 20 paragraph (4) Permenkes 24/2022.

[22] Article 22 paragraph (1) Permenkes 24/2022.

[23] Article 22 paragraph (2) Permenkes 24/2022.

[24] Article 39 paragraph (1) Permenkes 24/2022.

[25] Article 39 paragraph (2) Permenkes 24/2022.

[26] Article 33 paragraph (2) Permenkes 24/2022.

[27] Article 33 paragraph (3) Permenkes 24/2022.

[28] Article 34 paragraph (1) Permenkes 24/2022.

[29] Article 34 paragraph (2) Permenkes 24/2022.

[30] Article 34 paragraph (3) Permenkes 24/2022.

[31] Article 34 paragraph (5) Permenkes 24/2022.

[32] Article 34 paragraph (6) Permenkes 24/2022.

[33] Article 35 paragraph (1) Permenkes 24/2022.

[34] Article 36 paragraph (1) Permenkes 24/2022.

[35] Article 36 paragraph (3) Permenkes 24/2022.

[36] Article 36 paragraph (4) Permenkes 24/2022.

[37] Article 37 Permenkes 24/2022.