Result card

  • LEG15: Is Structured telephone support (STS) for adult patients with chronic heart failure so novel existing legislation was not designed to cover its regulation?
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Is Structured telephone support (STS) for adult patients with chronic heart failure so novel existing legislation was not designed to cover its regulation?

Authors: Ingrid Wilbacher, Valentina Prevolnik Rupel

Internal reviewers: Ingrid Rosian

Search among EU websites and in google for legal regulations of telemonitoring/ STS, literature from the common project search.

Used:

COMMISSION STAFF WORKING DOCUMENT eHealth Action Plan 2012-2020

OECD – ICT document

Dubner et al. 2012

 

There is still legal uncertainty within the provision of structured telephone support for patients with chronic heart failure in terms of

  • Cross border healthcare services
  • Funding aspects
  • Reimbursement
  • Procurement
  • Sustainable business models
  • Data protection via telephone line
  • Provider responsibilities
  • The COMMISSION STAFF WORKING DOCUMENT eHealth Action Plan 2012-2020 – innovative healthcare for the 21st century Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS eHealth Action Plan 2012-2020 – innovative healthcare for the 21st century /* SWD/2012/0413 final */ {30} states Legal uncertainty in deploying eHealth (cross border) services, ineffective funding, reimbursement, procurement and sustainable business models (paragraph 3) and describes remaining challenges like the ”creation of a framework for greater legal certainty of eHealth products and services and the provision of online services in telemedicine and ePrescription by the majority of European health organisations and regions(3.1). Within paragraph 4.5 is written: ”Clinical and healthcare workflows, care models, and business processes are significantly more complex than equivalents in other sectors of the economy and less amenable to standardisation and streamlining by conventional eBusiness systems. Below, the results of the public consultation and the available evidence demonstrate other reasons and barriers for slow uptake of eHealth solutions including: the lack of awareness of, and confidence in,  eHealth solutions among patients, citizens and healthcare professionals; lack of interoperability between eHealth solutions; limited large-scale evidence of the cost-effectiveness of eHealth tools and services; lack of legal clarity for health and wellbeing mobile applications and the lack of transparency regarding the utilisation of data collected by such applications; inadequate or fragmented legal frameworks including the lack of reimbursement schemes for eHealth services and the high start-up costs involved in setting up eHealth systems.” One of the recommendations therefore includes to ”Create a legal framework and space to manage the explosion of health data. This needs to put in place the safeguards that will allow citizens to use health apps with confidence that their data is handled appropriately and subsequently it will create the conditions for the integration of user-generated data with official medical data so that care can be more integrated, personalised and useful for patients.”

There are Good Practive Guidelines existing for Chronic Patients with Cardiovascular disease {31}, which include legal aspects (3.2.5):

Healthcare via telemedicine is like any other care delivered by a health service . It requires

    • quality standards of care including the use of appropriately certified
    • equipment
    • evidence-based medicine
    • healthcare professionals to act within their scope of professional practice and statutory/regulatory framework
    • due regard for patient safety and wellbeing
    • clinical and research governance
    • ethical behaviour.”

As concerns are expressed:

    • the security of transfer of information from home monitoring equipment via the Internet and/or mobile telephone networks
    • specific clinical responsibilities within healthcare professionals providing telemedicine service
    • not clearly defined others’ roles

 

  • OECD – ICT document {32}

 

There are many aspects requiring legal governance ”ranging from professional and organisational accountability to means of quality measurement and quality assurance, including those which look at the totality of interagency care, as well as cross-agency leadership and co-ordination.” (p85)

 

  • Dubner 2012 {33} states an important comment: Every system with wireless capability has to be assessed to be secure against hackers and other unauthorized access to personal information stored in web-based servers .

 

Critical
Wilbacher I, Rupel V Result Card LEG15 In: Wilbacher I, Rupel V Legal aspects In: Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 3 October 2022]. Available from: http://corehta.info/ViewCover.aspx?id=305

References