Tinjauan Aspek Hukum: Rekam Medis Elektronik (Rme)

REKAM MEDIS ELEKTRONIK (RME):
Tinjauan Aspek Hukum
dr. Rano I Sudra, M.Kes

Health Information Management Consultant
Contoso
Pharmaceuticals
page 1
S3 – Candidate Doctor Ilmu Hukum (Hukum Kesehatan)

S2 – Magister Kesehatan (SIMKes) – UNDIP – 2003
S1 – FK UNDIP – 1992
Wadir Politeknik Rukun Abdi Luhur (POLTEKUN) - Kudus
Konsultan Rekam Medis & Manajemen Informasi Kesehatan
Pengurus DPP MHKI (Masyarakat Hukum Kesehatan Indonesia)
Pengurus DPW MHKI Jateng
Konsultan Akademik beberapa Perguruan Tinggi
Dosen bidang RMIK (D3, D4, S1)
dr. Rano I Sudra, M.Kes Dosen S2 SIMKES & S2 Hukum Kesehatan
Health Information Management Consultant
Reviewer dan Editor Jurnal Hukum Kesehatan Indonesia (JHKI)
rano.indradi@gmail.com
08112702894 Reviewer Jurnal Manajemen Informasi & Administrasi Kesehatan (JMIAK)
Narasumber berbagai seminar & pelatihan bidang RMIK
Penulis buku Rekam Medis & Manajemen Informasi Kesehatan
Pemilik & Pengelola RanoCenter
2
Beberapa
Publikasi
3
4
5
page 6
Transformasi Digital Yankes
Dimulai dengan
Digitalisasi Rekam Medis
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Memahami
KONSEP RME
SLIDESMANIA.COM
Contos
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Pharmaceuticals
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An electronic health record
is not a simple replacement
of the paper record.
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What are Electronic Medical Records?
The IOM 2003 Patient Safety Report describes an EMR as
encompassing:
• “a longitudinal collection of electronic health information for

and about persons
• Immediate electronic access to person- and population-level

information by authorized users;
• Provision of knowledge and decision-support systems that

enhance the quality, safety, and efficiency of patient care and
• Support for efficient processes for health care delivery.”
11
"If it's not documented,

it did not happen"
12
Kemana arah
pengembangan RME
di Indonesia ???
SLIDESMANIA.COM
Contos
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Pharmaceuticals
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14
Standardisasi Healthcare
CDI Data Analitycs
Regulasi Pemberdayaan Human

Pasien (Stake holder) Aspects
Tantangan & Peluang

Dalam Digitalisasi Rekam Medis
page 15
Berbagai Aspek Terkait

Digitalisasi Rekam Medis
16
page 17
Prioritas Transformasi Teknologi Kesehatan
page 18
Interoperabilitas
page 19
Tantangan & Alternatif Solusi Interoperabilitas

Tantangan Alternatif Solusi
page 20
page 21
page 22
page 23
Kebutuhan REGULASI
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Health
ITC Management
Law
25
Regulasi Terkait
Manajemen RM/RME
Contoso
Pharmaceuticals
page 26
PP No.10/1966 tentang Wajib Simpan Rahasia Kedokteran
SE Dirjen Yanmed No.HK.00.06.1.5.01160 tahun 1995 tentang
Petunjuk Teknis Pengadaan Formulir RM Dasar dan
Pemusnahan Arsip RM di RS
SK Dirjen Yanmed No.HK.00.05.1.4.00744 tahun 1996 tentang
Penggunaan Klasifikasi Internasional Mengenai Penyakit
Revisi Kesepuluh (ICD-10) di RS
UU No.7/1971 tentang Ketentuan-ketentuan Pokok Kearsipan
UU No.29/2004 tentang Praktik Kedokteran
PMK No.269/2008 tentang Rekam Medis
PMK No.290/2008 tentang Persetujuan Tindakan Kedokteran
PMK No.1171/2011 tentang SI RS
27
PMK No.36/2012 tentang Rahasia Kedokteran

PMK No.55/2013 tentang Penyelenggaraan Pekj Perekam Medis
PMK No.82/2013 tentang SIMRS
UU No.36/2014 tentang Tenaga Kesehatan
PP No.46/2014 tentang SIK
PMK No.36/2015 tentang Pencegahan Kecurangan (Fraud) Dalam
Pelaksanaan JamKes Pada SJSN
UU No.19/2016 tentang perubahan UU No.11/2008 tentang ITE
PMK No.46/2017 tentang Strategi e-Kesehatan Nasional
PP No.71/2019 tentang perubahan PP No.82/2012 tentang PSTE
PMK No.20/2019 tentang Penyelenggaraan Pelayanan
Telemedicine Antar Fasilitas Pelayanan Kesehatan
28
KMK No. HK.01.O7/MENKES/312/2020 tentang Standar Profesi
Perekam Medis dan Informasi Kesehatan
SE No.HK.02.01/MENKES/303/2020 tentang Penyelenggaraan
Pelayanan Kesehatan Melalui Pemanfaatan Teknologi Informasi
dan Komunikasi Dalam Rangka Pencegahan Penyebaran
Corona Virus Disease 2019 (COVID-19)
SK MKEK No.017/PB/K.MKEK/05/2020 tentang Fatwa Layanan
Telemedis dan Konsultasi Daring Khususnya dimasa Pandemi
COVID-19
Perkonsil No.74/2020 tentang Kewenangan Klinis dan Praktik
Kedokteran Melalui Telemicine Pada Masa Pandemi COVID-19
di Indonesia
PMK No.21/2020 tentang Renstra Kemkes 2020-2024
PP No.47/2021 tentang Penyelenggaraan Bidang Perumahsakitan
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page 33
Kebutuhan
STANDARDISASI
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Siapkan Kebutuhan Standardisasi
Terminologi (peristilahan)
Rumus
Satuan
Alur prosedur/ Proses
Batasan
page 35
Standardisasi
Text, Istilah
Gambar,
Diagnosis,
Suara, Format
Video, dsb Singkatan Tindakan,
data Obat,
TT, LD, HP, Pasien,
Perinatal, Kondisi,
Neonatal, dsb
Anak,
Dewasa, Proses/
Simbol
Pasien RI, Rumus Hasil pemeriksaan
Keluar, dsb fisik, Lab, Farmasi,
dsb
Satuan
36
Standards Relevant to Health Data
• Data Standards
• Information Content Standards
• Information Exchange Standards
• Entity/Person Identifiers Standards
• Privacy and Security Standards
• (Functional Standards; Business Requirements)
Source: Public Health Data Standards Consortium; http://www.phdsc.org/; Accessed: June 3, 2012
page 37
Data Standards • Disease Classification

• Drugs Classification
• Laboratory Data Standards
• Digital Images
• Medicinal Products, Pharmaceutical Doses,
Units, Common Terminology Services
Examples only
(non exhaustive list)
page 38
Data Standards • Clinical Procedure Terminology
• Pharmacy Terminology
• Nursing/HRH Terminology
• Payer Terminology
• Financial/Business Transactions Terminology
• Units of Measurements
Examples only
page 39
Information • Healthcare Content

• Public Health Card
Content
• Medical Device Communication
Standards
Examples only
page 40
Information • Digital Images
• Pharmacy Business Transactions
Exchange
• Country-specific Mandated Transactions
Standards Terminology
• Financial/Business Transactions Terminology
Examples only
page 41
Entity/Person • Patient Identifier

• Provider Identifier
Identifier • Employer Identification Number
Standards • Country Identifier
• Health (Insurance) Card Issuer Identifier
Examples only
page 42
Information • Standard Generalized Markup Language
(SGML) ISO 8879:1986
Technology • HyperText Markup Language (HTML)
Standards ISO 8859-1
• Extensible Markup Language (XML)
• Simple Object Access Protocol (SOAP)
ISO/IEC 40210:2011
Examples only
page 43
Privacy and • Anonymization and

Security Pseudonymization
Standards Standards
• Security Standards
• Confidentiality Standards
• Patient Consent Standards
• Data Audit Trails
Examples only
page 44
Anonimitas
Informasi terkait identitas :
1. Nama
2. Alamat (nama jalan, kota, desa, RT, RW)
3. Tanggal terkait individu (tgl lahir, admisi, keluar RS/ kematian)
4. Usia (diatas 89, atau sesuai ketentuan berlaku)
5. Nomor telepon
6. Nomor fax
7. Alamat email
8. Nomor Induk Kependudukan (NIK)
45
Anonimitas (lanjutan) :
9. Nomor rekam medis
10. Nomor asurasi
11. Nomor akun/ keanggotaan
12. Nomor sertifikat/ lisensi
13. Nomor dan jenis kendaraan
14. Identitas alat yang digunakan/ nomor seri
15. Alamat Universal resource locations (URL's)
16. Alamat Internet protocol addresses (IP's)
17. Identitas biometrik (sidik jari, warna mata, pola suara, pola wajah, dsb)
18. Foto wajah, termasuk gambar yang bisa dibandingkan
19. Semua nomor identitas unik, karakteristik, atau kode lainnya
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54
Pengaturan
Hak Akses
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Open, Read Copy, Download,

Melihat, Print
Membaca Menyalin, Unduh, Cetak,
Akses
Terhadap
Forward
Mengirim,
Edit
Mengubah,
Data Yankes
Meneruskan Menambah, Contoso
Pharmaceuticals
rano.indradi@gmail.com Mengurangi,
page 56
Menghapus
✓ subyek pengakses,
✓ kebijakan & prosedur ijin akses,
✓ tata cara akses,
tempat dan sarana akses,
Akses : ✓
✓ area data yang diakses,
✓ batasan waktu akses,
✓ batasan aktifitas saat akses,
✓ audit trail kegiatan akses.
SLIDESMANIA.COM
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SLIDESMANIA.COM
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Potensi Problematika
Akses Pasien Terhadap RME
- Regulasi: retensi, kepemilikan, akses
- Human aspect: perceptive, perspective, practice.
- Authentication
- Authorization
- Audit trail
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page 69
Teknologi
bukan PESAING
(jangan bersaing),
tapi PENDAMPING karir
(mari bersanding). Take away
Messages
Education
is an investement.
Contoso
Pharmaceuticals
page 70
Terima Kasih
dr. Rano Indradi S, M.Kes
08112702894
Contoso
Pharmaceuticals
page 71

Tinjauan Aspek Hukum: Rekam Medis Elektronik (Rme)

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REKAM MEDIS ELEKTRONIK (RME):

Tinjauan Aspek Hukum

dr. Rano I Sudra, M.Kes

S3 – Candidate Doctor Ilmu Hukum (Hukum Kesehatan)

• “a longitudinal collection of electronic health information for

• Immediate electronic access to person- and population-level

• Provision of knowledge and decision-support systems that

• Support for efficient processes for health care delivery.”

"If it's not documented,

Regulasi Pemberdayaan Human

Tantangan & Peluang

Berbagai Aspek Terkait

Prioritas Transformasi Teknologi Kesehatan

Tantangan & Alternatif Solusi Interoperabilitas

PMK No.36/2012 tentang Rahasia Kedokteran

Data Standards • Disease Classification

Information • Healthcare Content

Entity/Person • Patient Identifier

Privacy and • Anonymization and

Open, Read Copy, Download,

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