Legal Protection for Medical Laboratories Concerning Risk-Based Business Licensing Standards and the Fulfillment of Clinical Pathology Specialist

Medical laboratories play a crucial role in the healthcare system but often face regulatory challenges, particularly in the context of licensing. The amendment to the Ministry of Health Regulation on the Standards of Business Activities and Risk-Based Licensing in the Health Sector, which requires C...

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Main Authors: Etik Nunuk Setyorini, Mokhamad Khoirul Huda, Andika Persada Putra
Format: Article
Language:English
Published: LPPM Universitas Muhammadiyah Sorong 2024-11-01
Series:Justisi
Subjects:
Online Access:https://ejournal.um-sorong.ac.id/index.php/js/article/view/3644
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author Etik Nunuk Setyorini
Mokhamad Khoirul Huda
Andika Persada Putra
author_facet Etik Nunuk Setyorini
Mokhamad Khoirul Huda
Andika Persada Putra
author_sort Etik Nunuk Setyorini
collection DOAJ
description Medical laboratories play a crucial role in the healthcare system but often face regulatory challenges, particularly in the context of licensing. The amendment to the Ministry of Health Regulation on the Standards of Business Activities and Risk-Based Licensing in the Health Sector, which requires Clinical Pathology Specialists (DSPK) as the responsible physician, replacing general practitioners, has created difficulties for medical laboratory operators. The main issue is the uneven distribution of DSPK across Indonesia, which impacts the operation of medical laboratories. This research aims to analyze the legal protection of medical laboratories concerning the fulfillment of risk-based business licensing standards, particularly regarding the requirement for DSPK. The research employs a normative juridical method by examining relevant laws, government regulations, and judicial decisions. The results indicate that in the formulation of regulation, the legislative rationale must consider philosophical, sociological, and juridical aspects. However, the sociological aspects is not fully addressed due to the uneven distribution of DSPK, rendering the regulation ineffective at the national level. This issue hampers public access to quality laboratory services. Therefore, legal protection is needed to ensure that national health standards are achieved without creating disparities in access to healthcare services across different regions.
format Article
id doaj-art-9be4a45eebd8466290eaafce38348389
institution Kabale University
issn 1979-7532
2686-0821
language English
publishDate 2024-11-01
publisher LPPM Universitas Muhammadiyah Sorong
record_format Article
series Justisi
spelling doaj-art-9be4a45eebd8466290eaafce383483892025-02-03T11:02:17ZengLPPM Universitas Muhammadiyah SorongJustisi1979-75322686-08212024-11-01111627610.33506/js.v11i1.36443933Legal Protection for Medical Laboratories Concerning Risk-Based Business Licensing Standards and the Fulfillment of Clinical Pathology SpecialistEtik Nunuk Setyorini0Mokhamad Khoirul Huda1Andika Persada Putra2Hang Tuah UniversityHang Tuah UniversityHang Tuah UniversityMedical laboratories play a crucial role in the healthcare system but often face regulatory challenges, particularly in the context of licensing. The amendment to the Ministry of Health Regulation on the Standards of Business Activities and Risk-Based Licensing in the Health Sector, which requires Clinical Pathology Specialists (DSPK) as the responsible physician, replacing general practitioners, has created difficulties for medical laboratory operators. The main issue is the uneven distribution of DSPK across Indonesia, which impacts the operation of medical laboratories. This research aims to analyze the legal protection of medical laboratories concerning the fulfillment of risk-based business licensing standards, particularly regarding the requirement for DSPK. The research employs a normative juridical method by examining relevant laws, government regulations, and judicial decisions. The results indicate that in the formulation of regulation, the legislative rationale must consider philosophical, sociological, and juridical aspects. However, the sociological aspects is not fully addressed due to the uneven distribution of DSPK, rendering the regulation ineffective at the national level. This issue hampers public access to quality laboratory services. Therefore, legal protection is needed to ensure that national health standards are achieved without creating disparities in access to healthcare services across different regions.https://ejournal.um-sorong.ac.id/index.php/js/article/view/3644health sector; licensing; medical laboratory; minister of health regulation; protection.
spellingShingle Etik Nunuk Setyorini
Mokhamad Khoirul Huda
Andika Persada Putra
Legal Protection for Medical Laboratories Concerning Risk-Based Business Licensing Standards and the Fulfillment of Clinical Pathology Specialist
Justisi
health sector; licensing; medical laboratory; minister of health regulation; protection.
title Legal Protection for Medical Laboratories Concerning Risk-Based Business Licensing Standards and the Fulfillment of Clinical Pathology Specialist
title_full Legal Protection for Medical Laboratories Concerning Risk-Based Business Licensing Standards and the Fulfillment of Clinical Pathology Specialist
title_fullStr Legal Protection for Medical Laboratories Concerning Risk-Based Business Licensing Standards and the Fulfillment of Clinical Pathology Specialist
title_full_unstemmed Legal Protection for Medical Laboratories Concerning Risk-Based Business Licensing Standards and the Fulfillment of Clinical Pathology Specialist
title_short Legal Protection for Medical Laboratories Concerning Risk-Based Business Licensing Standards and the Fulfillment of Clinical Pathology Specialist
title_sort legal protection for medical laboratories concerning risk based business licensing standards and the fulfillment of clinical pathology specialist
topic health sector; licensing; medical laboratory; minister of health regulation; protection.
url https://ejournal.um-sorong.ac.id/index.php/js/article/view/3644
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AT mokhamadkhoirulhuda legalprotectionformedicallaboratoriesconcerningriskbasedbusinesslicensingstandardsandthefulfillmentofclinicalpathologyspecialist
AT andikapersadaputra legalprotectionformedicallaboratoriesconcerningriskbasedbusinesslicensingstandardsandthefulfillmentofclinicalpathologyspecialist