Definition · Healthcare AI Governance

Digital Health Innovation (Inovasi Digital Kesehatan / IDK) under KMK 1280/2023

Under Annex I Chapter I.B.2 of Minister of Health Decree No. HK.01.07/MENKES/1280/2023, Digital Health Innovation (IDK) is the renewal of business processes, business models.

Under Annex I (Chapter I.B.2) of Minister of Health Decree (KMK) No. HK.01.07/MENKES/1280/2023, Digital Health Innovation (Inovasi Digital Kesehatan or IDK) is defined as activities renewing business processes, business models. In addition, Instruments in health service delivery that provide new added value in the health services sector involving a digital ecosystem.

Regulatory Origin

Enacted on 4 April 2023 (Dictum EIGHTH), KMK 1280/2023 governs the development of the IDK ecosystem through a regulatory sandbox to foster safe. Quality, accountable innovations with managed risk and user protection (Dictum FIRST). General IDK criteria include using information and communication technology as the primary service channel, safeguarding users. Furthermore, Health workers, protecting personal data, and maintaining risk management (Chapter I.E.2). The guideline maps eight IDK clusters, prioritizing telehealth, pharmacy and medical device services. Furthermore, Health marketplaces, while listing artificial intelligence among non-priority clusters (Chapter I.E.3).

Why It Matters in Practice

Sandbox participants hold one of three statuses: Recorded (Tercatat), Supervised (Diawasi), or Mentored (Dibina) (Chapter II.A). Section G requires Supervised or Mentored participants to display the Ministry of Health logo. Furthermore, Status on their platform, whereas Chapter III.E.2 describes logo display as a right. Calling a product an "IDK" alone does not indicate sandbox status.

Related terms: IDK Ecosystem (Chapter I.B.3) and Cluster (Chapter I.B.5).

Legal basis: KMK No. HK.01.07/MENKES/1280/2023 Dictum FIRST and EIGHTH. Annex I Chapter I.B.1–3, I.B.5, I.E.2–3, Chapter II.A, Chapter III.E.2, and Section G.

Related questions

What are the three participant statuses in the KMK 1280/2023 health regulatory sandbox?+
Under Annex I Chapter II.A of KMK 1280/2023, sandbox participants hold Recorded (Tercatat), Supervised (Diawasi), or Mentored (Dibina) status.
Which clusters are prioritized first under KMK 1280/2023?+
Annex I Chapter I.E.3 prioritizes three clusters: telehealth, pharmaceutical and medical device services, and health marketplaces, while listing artificial intelligence as a non-priority cluster.
How do clinics evaluate digital tools like MCU CoPilot for check-up workflows?+
Clinics verify that digital tools keep clinical decision-making with licensed doctors. MCU CoPilot drafts check-up summaries for the examining physician to review and sign.

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