italian vision for smart healthcare national agenda for e ... · national agenda for e-health the...

Eng. Chiara Basile

AgID

Digital Transformation Area

HIMSS ITALIAN COMMUNITY SESSION

2018 May 29

“National Agenda for e-Health”

ITALIAN VISION FOR SMART HEALTHCARE

National Agenda for e-Health

The Strategy for digital growth and the Three-year Plan for Information Technology in Public

Administration have defined the interventions dedicated to the digital healthcare ecosystem and the main

solutions aimed at improving healthcare services, limiting waste and inefficiencies, improving the cost-quality ratio

of healthcare services and reducing the differences among regions.

The ICT Strategic ModelThe Strategic Model can be schematically represented by the graphic:

•The Tools for the generation and

diffusion of digital services define

common rules for the design of interfaces,

services and content,

•The Ecosystems are the policy sectors

or areas where public administration takes

action

•The Interoperability model defines the

mechanisms that facilitate and ensure

correct interaction between the players in

the system

•The Physical infrastructures aim to

increase security, reduce the cost of

technological infrastructure through

rationalisation of Data centers, the

systematic adoption of the cloud pardigm

and the development of connectivity,

e-Health Ecosystem in the ICT strategyThe Healthcare ecosystem has been defined in accordance with the “Health Protection Mission” and the Strategy

Paper for Digital Growth 2014-2020, which identifies the “Digital Healthcare” action.

e-Health Ecosystem in the ICT strategy

•Electronic Health Record (EHR), as an

example of an enabling infrastructure;

•Single Booking center (Centro unico di

prenotazione - CUP), as an example of

simplification of the interaction between

the Public Administration and the citizen;

•Telemedicine, as an example of

connection with the territory.

EHR

Single Booking Center

Telemedicine

The Three-Year Plan for ICT in the Public Administration highlights three projects in this field:

e-Health Ecosystem in the ICT strategy

Electronic Health Record

*Art. 12 c. 1 Law n. 221/2012

Hospitalization

Outpatientcare

Pharmaceutical healthcare

Residentialcare

Homecare

Emergency

…

Patient

Health

Professional

EHR

Electronic health record (EHR) is a set of digital data and documents relating to health and

social health related to the patient and generated from present and past clinical events. (*)

The main legal requirements for Electronic Health Record

AgID is responsible for

design the national

infrastructure for

interoperability

D.P.C.M. 29 September 2015, n. 178

Regolamento in materia di FSE

Guide lines

Technical specification for

interoperability

Decree of the President

of the Council of

Ministers November 11

no.178/2015 define

purposes and technical

specification needed to

implement EHR regional

platforms

March 2014

September 2017

Legislative Decree October 18 2012,

no. 179 and subsequent

amendments: set up of the national

EHR implemented by regions and

define set of data and documents


The EHR is made, with the consent of the patient, by the Regions and Autonomous Provinces for

purposes of prevention, diagnosis, treatment and rehabilitation.

Consultation of data and documents in the Electronic Health Record, for the purposes of care, can

be achieved only with the consent of the patient, except in cases of medical emergency in a manner

determined by regulation. The lack of consent does not affect the rights of health service delivery.

Law no. 179/2012 and subsequent amendments


Law no. no. 179/2012 and subsequent amendments

CARE

Prevention,diagnosis, treatment and rehabilitation.

These aims are pursued by the entities of theNational Health Service and of the

regional social-health services, that take care of

the patient.

RESEARCH

Study and research in themedical, biomedical andepidemiological sectors.

These aims are pursued by the regions and autonomous provinces, the Ministry of Health and the Ministry of

Labour and Social Policy, within their respectiveresponsibilities

assigned by law.

GOVERNANCE

Health planning, verification of the quality of care and

evaluation of health care.These aims are pursued by the

regions and autonomous provinces, the Ministry ofHealth and the Ministry of Labour and

Social Policy, within their respective responsibilities

assigned by law.

The EHR’s purposes are:

Electronic Health Record - Regulation Contents

Law n. 178/2015 has defined in a systematicway

The documents that are part of the EHR, with a

minimum dataset and the other documents

The content of the "patient summary" and the

content of the lab report (the first documents to

be activated, with technical details defined as well

in the decree)

The provisions for the protection of the

privacy of the patients (information, consent,

security measures)

Electronic Health Record - Regulation Contents

Minimum Dataset

a)identificative and

administrative data of the

patient;

b)medical reports;

c) emergency reports;

d)discharge letters;

e)patient summary;

f) pharmaceutical dossier;g)choice regarding the

donation of organs and

tissues.

a) prescriptions;

b) reservations;

c) medical records;

d) health checks;

e) home care;

f) diagnosis and treatment plans;

g) semi-residential care;

h) dispensing medications;

i) vaccinations;

l) outpatient care;

m) emergency care;

n) hospital care;

or) medical certificates;

p) patient's personal notebook

Other Documents

q)continuity of care

r) autocertification;

s) participating in clinical trials;

t) exemptions;

u)prosthetic assistance;v)data to support the activitiesof

telemonitoring;

z) data to support the activitiesof

the integrated management of

diagnostic and therapeutic;

aa) other relevant documents

National Infrastructure for Interoperability (INI)

In order to accelerate the IMPLEMENTATION OF THE INTEROPERABILITY SERVICES among the

Regional EHRs, and to speed-up deployment of EHR for Regions behind schedule, the law n.232/2016

modified the provisions regarding the National infrastructure for interoperability.

This infrastructure will provide also a complete EHR solution, to be used by those Regions where the local

implementation is late or too slow, hence enabling a timely roll-out of the EHR.

The INI has been designed by Digital Italy

Agency (AgID), in cooperation with Ministry

of Health and the Ministry of Economy and

Finance, and will be implemented and

managed by the Ministry of Economy and

Finance, within the framework of Italian health

insurance card

Interoperability model

Technical Standard

• Standard ISO/HL7 EHR-S FM R2 (Electronic Health Record System Functional Model Release 2)

• IHE (Integrating Health Enterprise)

Semantic Standard

• ICD 9-CM (International Classification of Diseases 9th revision Clinical Modification)

• LOINC® (Logical Observation Identifiers Names and Codes)

• HL7 CDA Rel. 2

EHR Regulation and state of the art of theimplementation

The Implementation of Italian Electronic Health Record

Active Regions

Active

Electronic

Health Record

digital clinical

report

Region % CDA2

P.A Trento 100%

Veneto 100%

Friuli Venezia Giulia

100%

Liguria 40%

Emilia Romagna 100%

Toscana 70%

Lazio 100%

Molise 100%

Puglia 50%

Sicilia 90%

Sardegna 85%

Digital Clinical Report : lab report

Financed by the Connecting Europe Facility (CEF), the NCPeH is aimed to prepare, test and

deploy the cross-border Patient Summary(PS) and the ePrescription(eP) taking into account the

already existing national infrastructure.

From EHR to NCPeH(National Contact Point for eHealth)

Cross border HealthcareDirective 2011/24/EU on patients’ rights in cross-border healthcare

• Creates a network of National Contact

• Creates EU rules on a minimum list of elements to be

included in a medical prescription taken from one EU

country to another (cross-border prescription)

• Encourages further development of European

Reference Networks of medical expertise,

broadening cooperation between EU countries, with

added benefits to health technology assessments

and e-health.

Cross border HealthcareDirective 2011/24/EU on patients’ rights in cross-border healthcare

Use Cases:

• Patient Summary, provides access forhealth professionals to verified keyhealth data of a patient during anunplanned care encounter while abroad

• ePrescription, enables patients toreceive equivalent medicationtreatment while abroad to what theywould receive in their home country

The interoperability challenge

The consortium involved in NCPeH implementation is composed of the Italian Ministry of

Health, Digital Italy Agency (AgID), Emilia Romagna, Lombardia and Veneto.

Italian National Contact Point for eHealth (NCPeH)

Benefits from the implementation of EHRThe implementation of the Electronic Health Record:

Significantly increases the level of appropriatenessof the responses to the health needs of the citizenand therefore also to pursue the sustainability ofthe health service

Provides assistance according to structured clinicalcare pathways that can be adapted in a flexibleand customized way to the health needs of thecitizen

Improves the quality of life of citizens, especiallywith regard to the elderly and people suffering fromvarious types of fragility and / or disability

Il Paese che cambia passa da qui.

agid.gov.it

Thank you