@MarcoPantera

Italian Community Session: Patient Data and the GDPR - How should I manage the Data? EHRs digital index and manual: how to ensure completeness, integrity and legal value of clinical documents

Marco Pantera – Lombardia Informatica

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LOMBARDY REGION AND THE REGIONAL HIS

≈ 10 million citizens (about the size of an average EU country)

≈ 7.500 General Practitioners

≈ 120 public hospitals ≈ 2.500 private HC organizations (hospitals, outpatient clinics, ...)

≈ 2.700 chemist's

Since the year 2000, Lombardy Region has developed a Regional Healthcare Information System (RHIS) connecting all actors involved in delivering "care" services

In 2016, RHIS users collectively produced:

Around 25 million digital clinical documents (e.g. medical reports, radiology reports, emergency room reports, …)

Over 90 million digital prescriptions

About 4 million appointments

+150.000 HC professionals ≈ 25 public hospitals have started EHR projects

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HIS GOVERNANCE IN LOMBARDY REGION

Lombardia Informatica Spa (LISPA) is the IT service company owned by Lombardy Region.

LISPA pursues the homogenous development of the regional Healthcare Information Systems at regional and hospital level, through the governance of common objectives and shared development plans.

In this context, LISPA has implemented a road map for governing the evolution of the providers' Healthcare Information Systems shown below:

Guidelines

Issue Guidelines for the development of HIS

Assessment

Assess the compliance of HIS with the regional guidelines through a maturity model

Planning

Address hospitals' IT development plans according to the results of the maturity model to reduce the gap for IT areas which obtained a lower score

Cooperation

Build shared services through joint working groups with healthcare providers

Since healthcare processes run on a regional scale, it is crucial to reach a homogeneous level of ICT maturity between all healthcare organizations to implement those shared processes smoothly

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MANAGING THE PAPER-TO-DIGITAL TRANSITION

Lombardia Informatica has delivered guidelines for Electronic Health Records management with the aim of fostering and implementing the use of digital documents in all healthcare processes

BUT

To successfully implement EHRs, during the transition we have to cope with the coexistence of digital documents alongside "traditional" paper documents The goal is ensuring access to all clinical information both to the physicians and to the patients

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OUR APPROACH

A pdf summary containing all the clinical documents is created to show the complete EHR to the patient

The main problem to solve was to keep track of all documents produced and determine a meaningful reading order

Our approach has been to adopt a structured Index of the EHR containing references to all paper and digital documents belonging to a specific clinical record

Through this Index, we can:

Keep track of all the documents composing the clinical records (digital and analogic)

Provide to users different views and reading orders, for example chronological or by type of documents …

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OUR SOLUTION – ULTIMATE GOAL

• Produce a digital copy through scanning of the original analogic (paper) documents • Digitally sign the scanned document in order to certify its correspondence with the original paper and to

grant legal value to its digital copy

collect acquire sign register destroy

• EHR becomes completely digital

• Document consultation is very user-friendly

• Organizing the process is costly (especially in the document production phase)

A process has to be implemented in order to:

The paper document, according to the Italian law, can then be destroyed (though a formalized process defined with the collaboration of national entities)

Paper

Digitally signed

…….…

…Link 1

Link 2

Link 3

Link…

Link N

Index to the

EHR

Digitally signed

Digitally signed

…

Digital doc

…….…

…

Italian Community Session: Patient Data and the GDPR - How should I manage the Data? EHRs digital index and manual: how to ensure completeness, integrity and legal value of clinical documents

Elena Sini – Humanitas

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HUMANITAS

Humanitas Research Hospital is the flagship hospital of the Humanitas Group

• 48.000 inpatients per year • 2.400.000 outpatient visits per year • 2.300 Professionals

• Certified by the Joint Commission

International since 2002

• Teaching hospital • IRCCS in the immuno-degenerative research field

In Italy, private HDOs are accredited by the Region and provide health care services directly to the Italian citizens. The patients are free to choose where to get treated. The Government reimburses the clinical services based on the DRG system. Humanitas provides around 80% of its services to the NHS.

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EHR: PATIENT CARE CONTINUUM

Humanitas started an EHR project in late 2014 with the aim of becoming a digital and paperless hospital while enabling the empowerment of its own patients The EHR is nowadays widely spread within the hospital and covers all the services delivered to the patients: - 87% are native digital documents - 13% are paper documents (9% patient consent, ...) In order to become an effective paperless hospital, Humanitas implemented the regional and national guidelines (D.P.C.M. 13/11/2014) to manage successfully the transition from paper to digital documents ensuring full access to all the clinical information to clinicians and patients

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EHRS MANUAL AND DIGITAL INDEX

As outlined by the regional guidelines on EHR’s manual and digital index Humanitas implemented the index as a structured document that contains all the references of the clinical documents within the EHR (hash) and is digitally signed by the CMO (HSM Module) Humanitas defined that the index should be generated automatically at specific steps of the process, from the moment of the discharge of the patient till every last paper document that goes through the digital validation process - versioning

Patient discharge

Archiving process starts

(manual)

Documents scanning

Index and scanning

report

Doctype check

Digital documents sent to EHR

OK

KO

Missing documents report

Index generation

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KPIS

Patient Continuum project achieved benefits that can be divided into two broad categories: - Operational efficiency - Business results EHRs compliance check-list have been automated with benefit in terms of availability of the EHR folder

to the patient in less time - from some days to few hours

No need to print more than 4 million paper sheets Payback time of the EHR investment (3 years)

The EHR (digital documents and paper digitalized documents) is going to be available within the services of the Patient Portal “Humanitas con Te”

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IT IHE ARCHITECTURE AND THE ROLE OF PATIENT CONSENT

Repository XDS

MPI

EHR ADT RIS LIS …

Login

Patient consent

Physician

Patient @ Home

The patient Mario Rossi gives his consent at his first access to Humanitas, signing it digitally with graphometric signature

Mario Rossi ID 96121

Viewer Registry XDS

The physician can access all the medical reports/images for which the patient has given the consent

Patient @ Humanitas

Mario Rossi can modify his consent at any time through the Humanitas Patient Portal

Repository XDS

MPI

EHR ADT RIS LIS …

Mario Rossi ID 15289

Registry XDS

Repository XDS

MPI

EHR ADT RIS LIS …

Mario Rossi ID 3695

Registry XDS

PIX

Hospital 1

Hospital 2

Hospital 3

XCA

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PATIENT PORTAL ‘HUMANITAS CON TE’

The PP acts as a technology platform to support the relationship among the patients and Humanitas healthcare professionals with the aim to simplify and enable the engagement of all stakeholders of the care process by building an effective system of continuity of care, from the hospital to the territory. All the clinical reports are also available within the EHR regional network and portal (RHIS - SISS) Usage: • 25.000 patients are active on the Patient Portal • More than 200.000 clinical reports accessed by the patients • More than 10.000 DICOM studies available

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PATIENT PORTAL

EHR

My Account

App: Privacy, Upload, collaboration, Follow up

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PATIENT CARE CONTINUUM

Humanitas set up its own digital transformation project with the aim of:

become a paper less hospital

enable Patient empowerment

The challenge is to build a comprehensive information system that enables access to relevant information to the patient and a active role in services selection and personal data management

The need is to consolidate all the forms of patient related content in an unique clinical data platform

Opportunity

Adoption of well-renowned international interoperability standards (IHE) and regional and national guidelines on EHRs

Constraints

Strict regulatory issues, national privacy law and EU-GDPR

Thank you!

Marco Pantera – Lombardia Informatica

Elena Sini – Humanitas