2017 Infokes Sesi 2 AF Aspek Etik Informatika Kesehatan
Aspek Etika dan Regulasi terkait
dengan Informatika Kesehatan
Anis Fuad
Departemen Biostatistik, Epidemiologi dan Kesehatan Populasi
FK UGM
anisfuad@ugm.ac.id
Perpaduan antara evolusi teknologi dan
peradaban manusia
Teknologi
Informasi
Perilaku
manusia dalam
berinteraksi
secara sosial dan
bekerja
Menggunakan, menerima,
Adaptasi dan mengembangkan
What you fill in today may not be useful
tomorrow
Status asuhan
keperawatan
tercetak dengan
rapi di RSUD
Banyumas
Contoh penerapan paperless medical
record
http://www.jagatreview.com/2014/06/pr-rumah-sakit-pondok-indah-group-terapkansistem-informasi-rumah-sakit-digital/
Workflow pelayanan di National University
Hospital (NUH) Singapore
Rekam medis elektronik terintegrasi dengan
layanan farmasi
Essential requirements of Information Technology for Primary
Care (Peterson, 2012)
Supporting
the personal
relationship
Continuity of
care
Care
coordination
TIK di
pelayanan
kesehatan
dasar
Integrating
standard
workflow
Capturing
the
diagnostic
process
Essential requirements of Information Technology for Primary
Care (Peterson, 2012)
Supporting
the personal
relationship
-rujukan
berjenjang
-open data
standard
Continuity of
care
-mampu bertukar
informasi antar
nakes
Care
coordination
TIK di
pelayanan
kesehatan
dasar
- e atat pasie se agai perso
hanya diagnosis
-memelihara relasi dokter-pasien
-kontekstual
-sepanjang hayat
Integrating
standard
workflow
Capturing
the
diagnostic
process
uka
-standar pelayanan
primer
-alur kerja
dokter/nakes
-data elemen:
keluhan utama
riwayat penyakit
riwayat keluarga
sosial
-standar kode utk
layanan primer
Fitur TIK Kesehatan di Pelayanan Primer (Audet et al, 2014)
Menghasilkan
informasi
pasien
Menyediakan
register dan
laporan
Keterlibatan
pasien
Fitur TIK
Kes di
Layanan
Primer
Pertukaran
informasi
secara
elektronik
Fasilitas
pemasukan
perintah
(order entry)
Sistem
pendukung
keputusan
Fitur TIK Kesehatan di Pelayanan Primer (Audet et al, 2014)
Menghasilkan
informasi
pasien
pasien dapat :
-meminta rujukan online
-konsul lewat email
Keterlibatan
pasien
-peresepan online
-melihat hasil lab secara
online
-bertukar ringkasan klinik
dengan faskes lain
-bertukar hasil
lab/diagnostik dengan
faskes lain
-menerima ringkasan
kepulangan pasien yang
dirujuk dari faskes vertikal
-rekam medis pasien elektronik
-daftar obat setiap pasien
-daftar hasil lab
-ringkasan kunjungan
Menyediakan
register dan
laporan
Fitur TIK
Kes di
Layanan
Primer
Pertukaran
informasi
secara
elektronik
Fasilitas
pemasukan
perintah
(order entry)
Sistem
pendukung
keputusan
-daftar pasien menurut
diagnosis
-daftar pasien yg harus
skrining
-daftar pasien dg obat
tertentu
-daftar pasien dengan hasil
lab tertentu
-memasukan resep
-memasukkan daftar
pemeriksaan lab
-mengirim resep ke
farmasi
-melihat daftar lab yg
masih dalam proses
-alert interaksi/dosis obat
-alert hasil lab
-alert skrining
-mengirim reminder ke pasien
TIK pada pelayanan kesehatan dasar di negara berkembang
(Oluch et al, 2012)
• Kepatuhan terhadap penggunaan pedoman klinis meningkat jika
sistem reminder diterapkan
• Menurunnya kesalahan: data, penjadwalan, hasil lab, waktu tunggu
pasien
• Meningkatnya waktu yang dialokasikan oleh klinisi terhadap pasien
• Tantangan:
• Infrastruktur, listrik
• Ketrampilan menggunakan komputer
• Kepatuhan terhadap pedoman meski sudah mendapatkan reminder
MENU ENTRY DATA
MENU REPORT
Satu operator dengan 2 workstation
Dengan 2 aplikasi berbeda
Ada aplikasi billing system tetapi
Tidak memenuhi kebutuhan rumah sakit
Entry dg software
Billing system
Entry dg software
Askes
Status asuhan
keperawatan
tercetak dengan
rapi di RSUD
Banyumas
RSCM sudah menerapkan rekam medis
elektronik, e-prescribing, PACS
Proses Approval olehApoteker
7
(BPJS, Kemkes, Dinkes)
6
4
5
3
2
1
8(Availability, utilization, effectiveness, impact)
Hardware and Software Computing
Infrastructure
• Purely technical
• Physical devices
• Software
• network
• the user is not aware that most of this infrastructure exists until it
fails
Clinical Content
• everything on the data-information-knowledge
continuum that is stored in the system
• Clinical vocabulary/terminologies
• patie ts’ o ditio (e.g., la oratory test results,
discharge summaries, or radiographic images).
• demographic data and patient location
Human Computer Interface
• An interface enables unrelated entities to interact with the system
and includes aspects of the system that users can see, touch, or hear.
People
• represents the humans (e.g., software developers, system
configuration and training personnel, clinicians, and patients) involved
in the design, development, implementation, and use of HIT.
• includes the ways that systems help users think and make them feel
Workflow and Communication
• people often need to work cohesively with others in the health care
system to accomplish patient care
• workflow must be modified to adapt to the HIT, or the HIT system
must change
Internal Organizational Policies, Procedures,
and Culture
• orga izatio ’s i ter al stru tures, poli ies, a d pro edures affe t
every other dimension
External Rules, Regulations, and Pressures
• the external forces that facilitate or place constraints on the design,
development, implementation, use, and evaluation of HIT in the
clinical setting.
• Example?
System Measurement
and Monitoring
• HIT must be measured and monitored on a regular basis:
• availability – the extent to which features and functions are available and
ready for use
• utilization - to determine how the various features and functions are being
used by clinicians
• effectiveness - to ensure that anticipated outcomes are achieved
• Impact – to document unintended consequences that manifest themselves
following use of these systems
Kerangka Etik dalam Informatika Kesehatan
General Ethics
• 1. Principle of Autonomy
• All persons have a fundamental right to self-determination.
• 2. Principle of Equality and Justice
• All persons are equal as persons and have a right to be treated accordingly.
• 3. Principle of Beneficence
• All persons have a duty to advance the good of others where the nature of this good is in keeping
with the fundamental and ethically defensible values of the affected party.
• 4. Principle of Non-Malfeasance
• All persons have a duty to prevent harm to other persons insofar as it lies within their power to do
so without undue harm to themselves.
• 5. Principle of Impossibility
• All rights and duties hold subject to the condition that it is possible to meet them under the
circumstances that obtain.
• 6. Principle of Integrity
• Whoever has an obligation has a duty to fulfil that obligation to the best of their ability.
Information Ethics
• 1. Principle of Information-Privacy and Disposition
• All persons and group of persons have a fundamental right to privacy, and hence to control
over the collection, storage, access, use, communication, manipulation, linkage and
disposition of data about themselves.
• 2. Principle of Openness
• The collection, storage, access, use, communication, manipulation, linkage and disposition of
personal data must be disclosed in an appropriate and timely fashion to the subject or
subjects of those data.
• 3. Principle of Security
• Data that have been legitimately collected about persons or groups of persons should be
protected by all reasonable and appropriate measures against loss degradation, unauthorized
destruction, access, use, manipulation, linkage, modification or communication.
• 4. Principle of Access
• The subjects of electronic health records have the right of access to those records and the
right to correct them with respect to its accurateness, completeness and relevance
• 5. Principle of Legitimate Infringement
• The fundamental right of privacy and of control over the collection, storage, access, use, manipulation,
linkage, communication and disposition of personal data is conditioned only by the legitimate, appropriate
and relevant data-needs of a free, responsible and democratic society, and by the equal and competing rights
of others.
• 6. Principle of the Least Intrusive Alternative
• Any infringement of the privacy rights of a person or group of persons, and of their right of control over data
about them, may only occur in the least intrusive fashion and with a minimum of interference with the rights
of the affected parties.
• 7. Principle of Accountability
• Any infringement of the privacy rights of a person or group of persons, and of the right to control over data
about them, must be justified to the latter in good time and in an appropriate fashion. These general
principles of informatic ethics, when applied to the types of relationships into which HIPs enter in their
professional capacity and to the types of situations they encounter when thus engaged, give rise to more
specific ethical duties. The Rules of Conduct for HIPs that follow outline the more important of these ethical
duties. It should be noted that as with any rules of ethical conduct, these Rules cannot do more than provide
guidance. The precise way in which the Rules apply in a given context, and the precise nature of a particular
ethical right or obligation, depends on the specific nature of the relevant situation.
Kesimpulan
• SDM terlatih masih merupakan orang yang lebih tepat untuk memberikan pelayanan
kesehatan. Software tidak dianjurkan untuk mengesampingkan keputusan manusia
• Klinisi yang menggunakan perangkat informatik harus memiliki kualifikasi klinis dan
terlatih menggunakan software
• Perangkat elektronik harus dievaluasi dan divalidasi secara tepat
• Evaluasi meliputi kinerja, kemanjuran (efikasi) dan pengaruhnya terhadap organisasi,
budaya organisasi dan SDMnya
• Pengembang, pemelihara dan pengguna aplikasi harus wajib memperhatikan aspek etika
• Kewajiban melindungi kerahasiaan dan privacy harus seimbang dengan upaya melindungi
akses terhadap informasi
• Perlu ada tata kelola mengenai penggunaan data kesehatan elektronik untuk riset.
dengan Informatika Kesehatan
Anis Fuad
Departemen Biostatistik, Epidemiologi dan Kesehatan Populasi
FK UGM
anisfuad@ugm.ac.id
Perpaduan antara evolusi teknologi dan
peradaban manusia
Teknologi
Informasi
Perilaku
manusia dalam
berinteraksi
secara sosial dan
bekerja
Menggunakan, menerima,
Adaptasi dan mengembangkan
What you fill in today may not be useful
tomorrow
Status asuhan
keperawatan
tercetak dengan
rapi di RSUD
Banyumas
Contoh penerapan paperless medical
record
http://www.jagatreview.com/2014/06/pr-rumah-sakit-pondok-indah-group-terapkansistem-informasi-rumah-sakit-digital/
Workflow pelayanan di National University
Hospital (NUH) Singapore
Rekam medis elektronik terintegrasi dengan
layanan farmasi
Essential requirements of Information Technology for Primary
Care (Peterson, 2012)
Supporting
the personal
relationship
Continuity of
care
Care
coordination
TIK di
pelayanan
kesehatan
dasar
Integrating
standard
workflow
Capturing
the
diagnostic
process
Essential requirements of Information Technology for Primary
Care (Peterson, 2012)
Supporting
the personal
relationship
-rujukan
berjenjang
-open data
standard
Continuity of
care
-mampu bertukar
informasi antar
nakes
Care
coordination
TIK di
pelayanan
kesehatan
dasar
- e atat pasie se agai perso
hanya diagnosis
-memelihara relasi dokter-pasien
-kontekstual
-sepanjang hayat
Integrating
standard
workflow
Capturing
the
diagnostic
process
uka
-standar pelayanan
primer
-alur kerja
dokter/nakes
-data elemen:
keluhan utama
riwayat penyakit
riwayat keluarga
sosial
-standar kode utk
layanan primer
Fitur TIK Kesehatan di Pelayanan Primer (Audet et al, 2014)
Menghasilkan
informasi
pasien
Menyediakan
register dan
laporan
Keterlibatan
pasien
Fitur TIK
Kes di
Layanan
Primer
Pertukaran
informasi
secara
elektronik
Fasilitas
pemasukan
perintah
(order entry)
Sistem
pendukung
keputusan
Fitur TIK Kesehatan di Pelayanan Primer (Audet et al, 2014)
Menghasilkan
informasi
pasien
pasien dapat :
-meminta rujukan online
-konsul lewat email
Keterlibatan
pasien
-peresepan online
-melihat hasil lab secara
online
-bertukar ringkasan klinik
dengan faskes lain
-bertukar hasil
lab/diagnostik dengan
faskes lain
-menerima ringkasan
kepulangan pasien yang
dirujuk dari faskes vertikal
-rekam medis pasien elektronik
-daftar obat setiap pasien
-daftar hasil lab
-ringkasan kunjungan
Menyediakan
register dan
laporan
Fitur TIK
Kes di
Layanan
Primer
Pertukaran
informasi
secara
elektronik
Fasilitas
pemasukan
perintah
(order entry)
Sistem
pendukung
keputusan
-daftar pasien menurut
diagnosis
-daftar pasien yg harus
skrining
-daftar pasien dg obat
tertentu
-daftar pasien dengan hasil
lab tertentu
-memasukan resep
-memasukkan daftar
pemeriksaan lab
-mengirim resep ke
farmasi
-melihat daftar lab yg
masih dalam proses
-alert interaksi/dosis obat
-alert hasil lab
-alert skrining
-mengirim reminder ke pasien
TIK pada pelayanan kesehatan dasar di negara berkembang
(Oluch et al, 2012)
• Kepatuhan terhadap penggunaan pedoman klinis meningkat jika
sistem reminder diterapkan
• Menurunnya kesalahan: data, penjadwalan, hasil lab, waktu tunggu
pasien
• Meningkatnya waktu yang dialokasikan oleh klinisi terhadap pasien
• Tantangan:
• Infrastruktur, listrik
• Ketrampilan menggunakan komputer
• Kepatuhan terhadap pedoman meski sudah mendapatkan reminder
MENU ENTRY DATA
MENU REPORT
Satu operator dengan 2 workstation
Dengan 2 aplikasi berbeda
Ada aplikasi billing system tetapi
Tidak memenuhi kebutuhan rumah sakit
Entry dg software
Billing system
Entry dg software
Askes
Status asuhan
keperawatan
tercetak dengan
rapi di RSUD
Banyumas
RSCM sudah menerapkan rekam medis
elektronik, e-prescribing, PACS
Proses Approval olehApoteker
7
(BPJS, Kemkes, Dinkes)
6
4
5
3
2
1
8(Availability, utilization, effectiveness, impact)
Hardware and Software Computing
Infrastructure
• Purely technical
• Physical devices
• Software
• network
• the user is not aware that most of this infrastructure exists until it
fails
Clinical Content
• everything on the data-information-knowledge
continuum that is stored in the system
• Clinical vocabulary/terminologies
• patie ts’ o ditio (e.g., la oratory test results,
discharge summaries, or radiographic images).
• demographic data and patient location
Human Computer Interface
• An interface enables unrelated entities to interact with the system
and includes aspects of the system that users can see, touch, or hear.
People
• represents the humans (e.g., software developers, system
configuration and training personnel, clinicians, and patients) involved
in the design, development, implementation, and use of HIT.
• includes the ways that systems help users think and make them feel
Workflow and Communication
• people often need to work cohesively with others in the health care
system to accomplish patient care
• workflow must be modified to adapt to the HIT, or the HIT system
must change
Internal Organizational Policies, Procedures,
and Culture
• orga izatio ’s i ter al stru tures, poli ies, a d pro edures affe t
every other dimension
External Rules, Regulations, and Pressures
• the external forces that facilitate or place constraints on the design,
development, implementation, use, and evaluation of HIT in the
clinical setting.
• Example?
System Measurement
and Monitoring
• HIT must be measured and monitored on a regular basis:
• availability – the extent to which features and functions are available and
ready for use
• utilization - to determine how the various features and functions are being
used by clinicians
• effectiveness - to ensure that anticipated outcomes are achieved
• Impact – to document unintended consequences that manifest themselves
following use of these systems
Kerangka Etik dalam Informatika Kesehatan
General Ethics
• 1. Principle of Autonomy
• All persons have a fundamental right to self-determination.
• 2. Principle of Equality and Justice
• All persons are equal as persons and have a right to be treated accordingly.
• 3. Principle of Beneficence
• All persons have a duty to advance the good of others where the nature of this good is in keeping
with the fundamental and ethically defensible values of the affected party.
• 4. Principle of Non-Malfeasance
• All persons have a duty to prevent harm to other persons insofar as it lies within their power to do
so without undue harm to themselves.
• 5. Principle of Impossibility
• All rights and duties hold subject to the condition that it is possible to meet them under the
circumstances that obtain.
• 6. Principle of Integrity
• Whoever has an obligation has a duty to fulfil that obligation to the best of their ability.
Information Ethics
• 1. Principle of Information-Privacy and Disposition
• All persons and group of persons have a fundamental right to privacy, and hence to control
over the collection, storage, access, use, communication, manipulation, linkage and
disposition of data about themselves.
• 2. Principle of Openness
• The collection, storage, access, use, communication, manipulation, linkage and disposition of
personal data must be disclosed in an appropriate and timely fashion to the subject or
subjects of those data.
• 3. Principle of Security
• Data that have been legitimately collected about persons or groups of persons should be
protected by all reasonable and appropriate measures against loss degradation, unauthorized
destruction, access, use, manipulation, linkage, modification or communication.
• 4. Principle of Access
• The subjects of electronic health records have the right of access to those records and the
right to correct them with respect to its accurateness, completeness and relevance
• 5. Principle of Legitimate Infringement
• The fundamental right of privacy and of control over the collection, storage, access, use, manipulation,
linkage, communication and disposition of personal data is conditioned only by the legitimate, appropriate
and relevant data-needs of a free, responsible and democratic society, and by the equal and competing rights
of others.
• 6. Principle of the Least Intrusive Alternative
• Any infringement of the privacy rights of a person or group of persons, and of their right of control over data
about them, may only occur in the least intrusive fashion and with a minimum of interference with the rights
of the affected parties.
• 7. Principle of Accountability
• Any infringement of the privacy rights of a person or group of persons, and of the right to control over data
about them, must be justified to the latter in good time and in an appropriate fashion. These general
principles of informatic ethics, when applied to the types of relationships into which HIPs enter in their
professional capacity and to the types of situations they encounter when thus engaged, give rise to more
specific ethical duties. The Rules of Conduct for HIPs that follow outline the more important of these ethical
duties. It should be noted that as with any rules of ethical conduct, these Rules cannot do more than provide
guidance. The precise way in which the Rules apply in a given context, and the precise nature of a particular
ethical right or obligation, depends on the specific nature of the relevant situation.
Kesimpulan
• SDM terlatih masih merupakan orang yang lebih tepat untuk memberikan pelayanan
kesehatan. Software tidak dianjurkan untuk mengesampingkan keputusan manusia
• Klinisi yang menggunakan perangkat informatik harus memiliki kualifikasi klinis dan
terlatih menggunakan software
• Perangkat elektronik harus dievaluasi dan divalidasi secara tepat
• Evaluasi meliputi kinerja, kemanjuran (efikasi) dan pengaruhnya terhadap organisasi,
budaya organisasi dan SDMnya
• Pengembang, pemelihara dan pengguna aplikasi harus wajib memperhatikan aspek etika
• Kewajiban melindungi kerahasiaan dan privacy harus seimbang dengan upaya melindungi
akses terhadap informasi
• Perlu ada tata kelola mengenai penggunaan data kesehatan elektronik untuk riset.