Aspek Etika dan Regulasi terkaitdengan 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-terapkan-sistem-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)

TIK di pelayanan kesehatan

dasar

Supporting the personal relationship

Integrating standard workflow

Capturing the

diagnostic process

Care coordination

Continuity of care

Essential requirements of Information Technology for Primary Care (Peterson, 2012)

TIK di pelayanan kesehatan

dasar

Supporting the personal relationship

Integrating standard workflow

Capturing the

diagnostic process

Care coordination

Continuity of care

-mencatat pasien sebagai “person” bukan hanya diagnosis-memelihara relasi dokter-pasien-kontekstual-sepanjang hayat

-standar pelayanan primer-alur kerja dokter/nakes

-data elemen:keluhan utamariwayat penyakitriwayat keluargasosial-standar kode utk layanan primer

-mampu bertukar informasi antar nakes

-rujukan berjenjang-open data standard

Fitur TIK Kesehatan di Pelayanan Primer (Audet et al, 2014)

Fitur TIK Kes di

Layanan Primer

Menghasilkan informasi

pasien

Menyediakan register dan

laporan

Fasilitas pemasukan

perintah (order entry)

Sistem pendukung keputusan

Pertukaran informasi

secara elektronik

Keterlibatan pasien

Fitur TIK Kesehatan di Pelayanan Primer (Audet et al, 2014)

Fitur TIK Kes di

Layanan Primer

Menghasilkan informasi

pasien

Menyediakan register dan

laporan

Fasilitas pemasukan

perintah (order entry)

Sistem pendukung keputusan

Pertukaran informasi

secara elektronik

Keterlibatan pasien

-rekam medis pasien elektronik-daftar obat setiap pasien-daftar hasil lab-ringkasan kunjungan

-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

pasien dapat :-meminta rujukan online-konsul lewat email-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

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 workstationDengan 2 aplikasi berbeda

Ada aplikasi billing system tetapiTidak memenuhi kebutuhan rumah sakit

Entry dg software

Billing system

Entry dg software

Askes

Status asuhan keperawatan tercetak dengan rapi di RSUD Banyumas

Proses Approval olehApoteker

RSCM sudah menerapkan rekam medis elektronik, e-prescribing, PACS

1

2

3

4

5

6

7

8(Availability, utilization, effectiveness, impact)

(BPJS, Kemkes, Dinkes)

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

• patients’ condition (e.g., laboratory 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• organization’s internal structures, policies, and procedures affect

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 pelayanankesehatan. Software tidak dianjurkan untuk mengesampingkan keputusan manusia

• Klinisi yang menggunakan perangkat informatik harus memiliki kualifikasi klinis danterlatih 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 melindungiakses terhadap informasi

• Perlu ada tata kelola mengenai penggunaan data kesehatan elektronik untuk riset.