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Telehealth & legal aspects. … Reimbursement, a prerequisite to a better deployment and use of telehealth … Telemedicine Andreas Gläser , COCIR. Agenda. Overall Situation (changes of Society & Healthcare needs)

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Telehealth legal aspects

Telehealth & legal aspects

… Reimbursement,

a prerequisite to a better deployment and use of telehealth …


Andreas Gläser , COCIR


  • Overall Situation (changes of Society & Healthcare needs)

  • Introduction to Telehealth

    • Definition

    • Examples

  • Evidence of Telehealth outcomes

    • Clinical Outcomes

    • Cost parameters

    • Users acceptance

  • Barriers hindering Telehealth deployment

  • COCIRs call for action

Telemedicine Focus Group 2nd March 2010


Situation - Changes of Society and Healthcare

Proportion of total EU-27 population*


*EUROSTAT Yearbook 2009

Demographic Change…

  • leads to an increasing proportion of people with (multiple) chronic conditions -> rising demand -> rising healthcare spendings

  • ageing caregivers ->reduction supply

  • need for preventive action

Telemedicine Focus Group 2nd March 2010


The Bigger Picture - What is Telemedicine?


delivery of healthcare services by use of Information and Communication Technologies (ICT)

while actors are not at the same location.


(Remote Patient Management)

Ambient Assisted


TeleCare(„House emergency call“)

  • Teledisciplines

  • TeleRadiologie

  • TeleScreening

TeleMonitoring(i.W. Vitalparameter)

Focus Doc-Doc Focus Doc-Patient Focus Social / Care

Telemedicine Focus Group 2nd March 2010


Focus on Telehealth

1. Telemonitoring 2. Telehealth

  • + Behaviour

  • + Knowledge

  • Vital parameter

  • Focus on Vital Signs

  • Therapy Management

  • Training & education programs

  • Emergency management

  • telephonic care

  • Simple results logic

Telemonitoring is a subset - or often the first implementation stage of Telehealth

Telemedicine Focus Group 2nd March 2010


Telehealth System Overview

Telemedicine Focus Group 2nd March 2010


Regulatory Matrix for Telehealth Systems

Combination of

MD and/ or

Non-MD to

MD System

MDD §12

Patient Interface


Clinical Interface



Telemedical Center


Telemedical Data center

  • 2D Risk Management

  • ISO 14971

  • IT Risk Mgt.

IT Infrastructure

Patient Data Location Rights

ISO 27001 Data Security

Access Rights Management

Data Encryption Management

IQ/OQ/PQ Validation IT Infrastructure

Update & Upgrade Rules S/W

Telemedicine Focus Group 2nd March 2010


Existing & Broad Evidence

  • Compliance improvements

  • Morbidity andmortality reduction

  • Better Health-related Quality of Life

  • Direct cost reductions: Hospitalisation, emergency incidents, GP visits, medication, etc.

  • Patient usage of service and satisfaction

  • Physician acceptance of new service






A large no. of studies and trials have proven the various positive outcomes of Telehealth enabled Healthcare.

Telemedicine Focus Group 2nd March 2010


Diabetes Mellitus | Mortality with diabetes

Chumbler et al. 2009




Mean Survival Time: 1348 vs. 1278 days (p=0.015)

Crude Mortality Rate: 19% vs. 26% (p<0.05)

Source: Chumbler et al. (2009), Mortality risk for diabetes patients in a care coordination, home-telehealth programme. Journal of Telemedicine and Telecare, 15: 98–101.

Telemedicine Focus Group 2nd March 2010


Cost | long-term study in US

Darkins et al. Telemedicine and e-Health, Dec 2008




Source: Darkins et al. 2008, CCHT: The Systematic Implementation of Health Informatics, Home Telehealth, and Disease Management to Support the Care of Veterans with Chronic Conditions, Telemedicine & e-Health, 14(10), 1118-1126

Telemedicine Focus Group 2nd March 2010


Acceptance | long-term study

Eighty-five percent (85%) are in daily compliance with device.



86% say they better understand their condition and treatment

and are better able to manage their chronic condition(s).


Over 95% are (very) satisfied with the Health Buddy, and most

of them would recommend it to others.

Source: Boyne et al., 2008, Telemonitoring in patients with heart failure:

A feasibility study (TEHAF). European Journal of Cardiovascular Nursing, 7, S20-S21.

Telemedicine Focus Group 2nd March 2010


Evidence Summary | Expected Benefits

  • Telehealth can fill a crucial gap in the continuum of care.

  • Telehealth solutions support a multi-dimensional model of care

  • for individuals with (complex) chronic conditions

  • who are often either elderly and frail and/or disabled.

  • The benefits of Telehealth are immediate, tangible and significant

  • to clinical staff, patients and society.

  • Reduced hospitalizations

  • Increased quality of life of patients

  • Reduced mortality

  • Early detection of exacerbations, impairment of health

  • Patient empowerment, education, behavioural reinforcement and motivation

  • Individualized, efficient, exception based interventions

Telemedicine Focus Group 2nd March 2010


But barrierscontinue to hinder the further deploymentof Telehealth

  • While the potential benefits of Telehealth are enormous, a number of barriers continue to hinder the introduction of Telehealth, or prevent them from achieving optimal benefits. Among them are:

  • No reimbursement or sustainable funding

  • Missing incentives, accordingly business models for care providers

  • Missing IT standards and issues on interoperability

  • Lack of awareness and confidence in maturity and positive results

  • Many smaller pilots addressed individual issues, but not overall solution

  • Two parallel infrastructures for Telehealth (new) and Telecare (existing)

  • Unclear legal responsibilities, different regulations within EU states

Telemedicine Focus Group 2nd March 2010


COCIR’s Call for Action to promote the further deployment of Telehealth

  • To overcome the barriers to make the benefits of Telehealth available to European citizens, COCIR calls to:

  • European Commission and Member States to establish an appropriate legal framework with effective transposition at country level

  • 2. Strengthen cooperation between healthcare stakeholders to “best practice health strategies” supporting telehealth adoption in routine clinical practice

  • 3. Finance more and sustainable large scale projects with health economic

  • evaluation to assess the impact of telehealth solutions

  • 4. Integrate telehealth into existing care delivery structures and ensure

  • interoperability of telehealth solutions

  • 5. Establish sustainable economic model for telehealth by starting dialogue

  • between healthcare stakeholders

Telemedicine Focus Group 2nd March 2010