Disclaimer
This information collection is a core HTA, i.e. an extensive analysis of one or more health technologies using all nine domains of the HTA Core Model. The core HTA is intended to be used as an information base for local (e.g. national or regional) HTAs.

Structured telephone support (STS) for adult patients with chronic heart failure

Structured telephone support (STS) for adult patients with chronic heart failure compared to Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home) in the prevention of Chronic cardiac failure in adults and elderly with chronic heart failure (CHF) AND hospitalization due to heart failure at least once AND without implanted devices

(See detailed scope below)

HTA Core Model Application for Medical and Surgical Interventions (2.0)
Core HTA
Published
Tom Jefferson (Agenas - Italy), Marina Cerbo (Agenas - Italy), Nicola Vicari (Agenas - Italy)
Neill Booth (THL - Finland), Plamen Dimitrov (NCPHA - Bulgaria), Mirjana Huic (AAZ - Croatia), Valentina Rupel (IER - Slovenia), Alessandra Lo Scalzo (Agenas - Italy), Ingrid Wilbacher (HVB - Austria)
Agenas - Agenzia nazionale per i servizi sanitari regionali
AAZ (Croatia), Agenas (Italy), ASSR RER (Italy), Avalia-t (Spain), CEM (Luxembourg), GÖG (Austria), HVB (Austria), IER (Slovenia), ISC III (Spain), NCPHA (Bulgaria), NIPH (Slovenia), NSPH (Greece), NSPH MD (Romania), SBU (Sweden), SNHTA (Switzerland), THL (Finland), UTA (Estonia).
9.9.2014 11.18.00
4.12.2015 17.51.00
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 8 August 2022]. Available from: http://corehta.info/ViewCover.aspx?id=305

Structured telephone support (STS) for adult patients with chronic heart failure

<< Social aspectsCollection appendices >>

Authors: Ingrid Wilbacher, Valentina Prevolnik Rupel

Summary

LEG 1 about marketing authorisation, registration is answered within the CUR domain, we did not do it twice.

LEG 2 about intellectual property right:

According to the Directive 2004/18/EC there are some aspects where the property rights regulation cannot be sufficiently precise, these areas have to be solved using the rules for governing open or restricted procedures.

The TRIPS agreement regulates trade-related aspects of intellectual property rights, including ideas, procedures, methods of operation or mathematical concepts, which also means software programs or source codes. Not included is the data or material itself. Members of TRIPS (=states) may exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of humans or animals.

Within the patent database EPO – European Patents registration one document was found about Telemedical expert service provision for „telemedicine“ / „telemonitoring“, which seems to be an ongoing negotiation.

For the implementation of telemonitoring one has to look at least for existing property rights on the used system, the implemented software, existing patents, and to secure/regulate the permission for use.

LEG 3 about the voluntary participation of patients:

Basic human rights include respect for integrity and right to fundamental freedom with regard to the application of medicine. The interest of the human being shall prevail over the sole interest of society or science, people have the right to equal access on healthcare of appropriate quality according to their needs. An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.

For structured telephone support as a telemonitoring approach for patients with chronic heart failure there is a need of patient-cooperation which implies the will of the patient to take this kind of healthcare.

LEG 4 about patients’ enough time to consider their decisions:

The necessary time for consideration is not legally regulated. It is a matter of individual appropriateness. This Assessment Element is updated and no longer within the legal domain of the HTA Core model 2.1

LEG 5 about securing patient data

Data networks and data communication between providers of tele-healthcare and patients have to secure and protect data sources according to legal data protection regulations.

There is existing data protection regulation on international level which is already adapted and integrated in all of the countries in EU, Norway, Switzerland. There are two additional recommendations for data protection of medical data and protection of private data within telecommunication services which have to be taken into account when implementing a telemonitoring service with STS.

In any case the data protection should be on awareness, especially with low-level support via usual telephone or cell phone line. The informed consent with the patient and the (written) agreement are necessary.

LEG 6 about guarantee of equal access:

Convention for the Protection of Human Rights, Article 14 – Prohibition of discrimination: The enjoyment of the rights and freedoms set forth in this Convention shall be secured without discrimination on any ground such as sex, race, colour, language, religion, political or other opinion, national or social origin, association with a national minority, property, birth or other status.

  • Everybody has the basic right to health care at the state of the art ("best care"). It can be discussed whether “structured telephone support” counts as “state of the art”
  • There are no exclusions/ special protection declarations for gender equality, prisoners, disabled, regional equalities
  • The level of quality is included into the right of good care, but there is a need of legal regulation about a minimum defined quality level to provide equal preconditions for everyone
  • Limited access to structured telephone support as a telemonitoring service for special persons are based on the balance between evidence of best outcome rates, economic calculations for the costs and reduction of possible disadvantages due to i.e. lack of compliance. The decision for inclusion/ exclusion into a structured telephone support service has to be transparent

 

LEG 7 about health-care tourism

Usually there is no health care tourism expected for structured telephone support for chronic heart failure patients. In case of (emergency) treatment abroad and re-transfer into the home-country the appropriate information and continuity of care has to be guaranteed. The routine provision of structured telephone support across borders (in our outside Europe) is expected to be limited by language.

LEG 8 about national/EU register

Due to overlaps with TEC domain we refer to the answer of TEC11

LEG 9 about product safety requirements:

There seem to be no major differences in product safety aspects comparing structured telephone support with usual care. The product safety and responsibility duties have to be followed in both settings. If telemonitoring/ stuctured telephone support is newly implemented there should be appropriate awareness for the safety structure to be equal/similar (or better) as in ”usual care”

LEG 10 about additional licensing fees:

Overlaps with patent binding. We refer to LEG 2.

LEG 11 about depth and length of the providers’ guarantee:

Within structured telephone support provided by a physical person (like a nurse) and/or a group of professionals evaluating deterioration from the collected data by STS, the guarantee for quality can be given via the professional licencing regulations as it is handled within hospitals.

LEG 12 about Regulation of the market

The Directive on public contracting assures price control of servies in case of contracting the whole STS service or in case of material purchasing for HF patients at home. Pricining within reimbursement system for STS (like DRG) is subject to national legislation. The pricing within DRG system must therefore take into account all national legislation and regulation, like national policy on wages or depreciation. However, when the material costs are built into DRG, again the procedures for the public contracting is important, in case of STS it oculd apply to the telephone lines and various equipment that is given to HF patients to monitor their health status at home (scales, meters for circumference of ankles etc).

LEG 13 about acquisition regulation:

If the provider of the telemonitoring by STS is a public organisation the acquisition control has to take place and is usually known and followed by the provider. For contracted parts within or connected with the STS telemonitoring the acquisition regulation could be relevant if a certain amount of costs (i.e. for software, for a company providing the whole package including structured telephone support) is reached. A bottom-up provision of structured telephone support using certain tools or a kind of subcontracted professional team should be aware of the existing acquisition legislation.

LEG 14 about marketing:

The marketing of medical devices is regulated within the Directive 93/42/EEC and has to be taken into account if non-implantable medical devices (like blood pressure devices) are used in connection with STS. This means, the device has to follow the CE regulations.

For the marketing of a special device or product within a provided service one should be aware about the definition of corruption.

Within medical services and/or medical devices advertising is regulated by local governments to prevent misinterpretation about the device or service.

LEG 15 about the coverage of regulation:

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

LEG 16 about liability issues:

For the provision of telemedical services/ STS several different legal regulations have to be followed, like:

  • Occupational laws
  • Hospital legislations
  • Good clinical practice
  • Health telematic law
  • Data protection law
  • E-government law
  • Consumer protection law
  • Signature law
  • E-commerce-law
  • Telecommunication law
  • Copyright/ patent protection
  • Media law

(list not exhaustive)

This means that there is uncertainty which liability limitations exist for what kind of service provision.

Due to the different involved system partner within tele-medicine/ STS there has to be a clear business plan to create a legal background and to fulfil different legal regulations. The core of this business plan could be the patients’ contract to only one contract partner, which is coordinating the different involved partners.

Introduction

This section provides some thoughts about different legal aspects within STS. Telemonitoring is an upcoming topic including high expectations about potential advantages, and with some already piloted bottom-up solutions in different settings. The legals aspects following the HTA core model structure aim to provide an overview of different aspects that have to be taken into account when bringing STS into action. In some aspects we did a broader view than just the focus on STS. This is caused by the variation of different telemonitoring approaches where STS is not always the only content but a combination of different approaches is done. A certain combination of telemonitoring can also be provided as a whole service-package by a company and is then maybe related to copyright-issues.

Recommendation: non-binding act

Directive: legal act of the European Union which requires member states to achieve a particular result

Regulation: legal act of the European Union that becomes immediately enforceable as law in all member states simultaneously

Treaty: agreement under international law entered into by actors in international law, namely sovereign states and international organizations

Convention: international treaty

Methodology

Frame

The collection scope is used in this domain.

TechnologyStructured telephone support (STS) for adult patients with chronic heart failure
Description

Telemonitoring via structured telephone support with focus on patient reported signs (symptoms of congestion, peripheral edema, pulmonary congestion, dyspnea on exertion, abdominal fullness), medication adherence, physiological data (like heart rate, blood pressure, body weight – measured by the patient with home-device), activity level; done in regular schedules using risk stratification (with fixed algorithm by call center staff or experience-based by specialized staff); done by dedicated call centers, center-based staff, nurses, AND reduced visits to a GP or heart center

Intended use of the technologyPrevention

Remote transmission of information to alleviate symptoms, relieve suffering and allow timely treatment for chronic heart failure

Target condition
Chronic cardiac failure
Target condition description

Heart failure is a condition in which the heart has lost the ability to pump enough blood to the body's tissues. With too little blood being delivered, the organs and other tissues do not receive enough oxygen and nutrients to function properly.

Target population

Target population sex: Any. Target population age: adults and elderly. Target population group: Patients who have the target condition.

Target population description

Patients with chronic heart failure (CHF; defined as I50 http://www.icd10data.com/ICD10CM/Codes/I00-I99/I30-I52/I50-/I50 ) AND hospitalization due to heart failure at least once  AND without implanted devices

ComparisonUsual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home)
Description

Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist; patient has to move (≠ at home)

Outcomes

Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL or HRQoL, harms

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
I0015Authorisation and safetyHas the technology national/EU level authorisation (marketing authorisation, registration, certification of safety, monitoring, qualification control, quality control)?yesHas Structured telephone support (STS) for adult patients with chronic heart failure national/EU level authorisation (marketing authorisation, registration, certification of safety, monitoring, qualification control, quality control)?
I0019Ownership and liabilityDoes the technology infringe some intellectual property right?yesDoes Structured telephone support (STS) for adult patients with chronic heart failure infringe some intellectual property right?
I0002Autonomy of the patientIs the voluntary participation of patients guaranteed properly?yesIs the voluntary participation of patients guaranteed properly?
I0004Autonomy of the patientIs it possible to give future patients enough time to consider their decisions?yesIs it possible to give future patients enough time to consider their decisions?
I0003Autonomy of the patientAre there relevant optional technologies that future patients should be allowed to consider?noWe did not restrict the technologies, so this question would be irrelevant. Alternatives in management of the disease are answered in CUR domain
I0005Autonomy of the patientIs it possible to obtain an advance directive on the use of the technology?noit is assumed that telemedical devices can only be used with patients' cooperation
I0009Privacy of the patientDo laws/ binding rules require appropriate measures for securing patient data?yesDo laws/ binding rules require appropriate measures for securing patient data?
I0010Privacy of the patientWhat levels of access to which kind of patient information exist in the chain of care?noWe subsum this in I0011
I0011Equality in health careDo laws/ binding rules require appropriate processes or resources to guarantee equal access to the technology?yesDo laws/ binding rules require appropriate processes or resources to guarantee equal access to Structured telephone support (STS) for adult patients with chronic heart failure?
I0014Equality in health careIs health-care tourism expected from/to other European countries?yesIs health-care tourism expected from/to other European countries?
I0012Equality in health careIs the technology subsidized by the society?yes
I0013Equality in health careIs there a wide variation in the acceptability of the technology across Europe?noAccepatbility is an ethical or social aspect, not a legal one (see update of the legal domain)
I0016Authorisation & safetyDoes the technology need to be listed in a national/EU register?yesDoes Structured telephone support (STS) for adult patients with chronic heart failure need to be listed in a national/EU register?
I0017Authorisation & safetyDoes the technology fulfil product safety requirements?yesDoes Structured telephone support (STS) for adult patients with chronic heart failure fulfil product safety requirements?
I0018Authorisation & safetyDoes the technology fulfil tissue safety requirements?nono tissues involved
I0020Ownership & liabilityDoes the introduction of the technology presume some additional licensing fees to be paid?yesDoes the introduction of Structured telephone support (STS) for adult patients with chronic heart failure presume some additional licensing fees to be paid?
I0021Ownership & liabilityWhat are the width, depth and length of the manufacturers guarantee?yesWhat are the width, depth and length of the manufacturers guarantee?
I0022Ownership & liabilityIs the user guide of the technology comprehensive enough?noThis question is based on pharmaceuticals
I0023Regulation of the marketIs the technology subject to price control?yesIs Structured telephone support (STS) for adult patients with chronic heart failure subject to price control?
I0024Regulation of the marketIs the technology subject to acquisition regulation?yesIs Structured telephone support (STS) for adult patients with chronic heart failure subject to acquisition regulation?
I0025Regulation of the marketIs the marketing of the technology to the patients restricted?yesIs the marketing of Structured telephone support (STS) for adult patients with chronic heart failure to the patients restricted?
I0026Legal regulation of novel/experimental techniquesIs the technology so novel existing legislation was not designed to cover its regulation?yesIs Structured telephone support (STS) for adult patients with chronic heart failure so novel existing legislation was not designed to cover its regulation?
I0027Legal regulation of novel/experimental techniquesHow the liability issues are solved according to existing legislation?yesHow the liability issues are solved according to existing legislation?
I0028Legal regulation of novel/experimental techniquesAre new legislative measures needed?noThis will be covered in I0026
I0029Legal regulation of novel/experimental techniquesIs the voluntary participation of patients guaranteed properly?noThis is double with I0002

Methodology description

The methodological guidelines and suggestions for legal documents within the HTA Core Model [1]were used as a basic.

The different legal documents (directives, recommendations, etc) were read – mainly on international level, because the EU legislations are ratified or at least guidance for the single countries. National legislation cannot be followed for all EU member states and Norway and Switzerland due to language restrictions. Were national legislation has to be taken into account this is mentioned and could be worked out among a national adaptation.

For the questions not sufficiently answered by official legislative documents on EU level or examples from national level a google search was added and/ or an expert opinion was taken as a base for the discussion.

The main literature search for the WP4_3 topic of STS was scanned for legal aspects mentioned within medical studies/ systematic reviews.

Quality assessment tools or criteria

The authors worked with a work/check/re-check method solving discordant aspects by discussion.

The usual review process was provided by one WP4_3 internal reviewer without legal background.

Analysis and synthesis

The results are provided by citations of legal articles/paragraphs either in full wording or in own conclusion. Some aspects could only be discussed due to lack of regulation.

Disclosure: the authors are not professional lawers but working within health technology assessment framework/ health system legislation. This report cannot be taken as a legal proof, but just as a support for what has to be taken into account for structured telephone support provision.

Result cards

Authorisation and safety

Result card for LEG1: "Has Structured telephone support (STS) for adult patients with chronic heart failure national/EU level authorisation (marketing authorisation, registration, certification of safety, monitoring, qualification control, quality control)?"

View full card
LEG1: Has Structured telephone support (STS) for adult patients with chronic heart failure national/EU level authorisation (marketing authorisation, registration, certification of safety, monitoring, qualification control, quality control)?
Method
Short Result
Result

Importance: Important

Transferability: Unspecified

Ownership and liability

Result card for LEG2: "Does Structured telephone support (STS) for adult patients with chronic heart failure infringe some intellectual property right?"

View full card
LEG2: Does Structured telephone support (STS) for adult patients with chronic heart failure infringe some intellectual property right?
Method
Short Result
Result

Importance: Important

Transferability: Unspecified

Autonomy of the patient

Result card for LEG3: "Is the voluntary participation of patients guaranteed properly?"

View full card
LEG3: Is the voluntary participation of patients guaranteed properly?
Method
Short Result
Result
Comment

Importance: Important

Transferability: Unspecified

Result card for LEG4: "Is it possible to give future patients enough time to consider their decisions?"

View full card
LEG4: Is it possible to give future patients enough time to consider their decisions?
Method
Result

Importance: Optional

Transferability: Unspecified

Privacy of the patient

Result card for LEG5: "Do laws/ binding rules require appropriate measures for securing patient data?"

View full card
LEG5: Do laws/ binding rules require appropriate measures for securing patient data?
Method
Frame
Short Result
Result
Comment

Importance: Critical

Transferability: Unspecified

Equality in health care

Result card for LEG6: "Do laws/ binding rules require appropriate processes or resources to guarantee equal access to Structured telephone support (STS) for adult patients with chronic heart failure?"

View full card
LEG6: Do laws/ binding rules require appropriate processes or resources to guarantee equal access to Structured telephone support (STS) for adult patients with chronic heart failure?
Method
Frame
Short Result
Result

Importance: Important

Transferability: Unspecified

Result card for LEG7: "Is health-care tourism expected from/to other European countries?"

View full card
LEG7: Is health-care tourism expected from/to other European countries?
Method
Short Result
Result

Importance: Optional

Transferability: Unspecified

Authorisation & safety

Result card for LEG8: "Does Structured telephone support (STS) for adult patients with chronic heart failure need to be listed in a national/EU register?"

View full card
LEG8: Does Structured telephone support (STS) for adult patients with chronic heart failure need to be listed in a national/EU register?
Method
Short Result

Importance: Optional

Transferability: Unspecified

Result card for LEG9: "Does Structured telephone support (STS) for adult patients with chronic heart failure fulfil product safety requirements?"

View full card
LEG9: Does Structured telephone support (STS) for adult patients with chronic heart failure fulfil product safety requirements?
Method
Frame
Short Result
Result

Importance: Optional

Transferability: Unspecified

Ownership & liability

Result card for LEG10: "Does the introduction of Structured telephone support (STS) for adult patients with chronic heart failure presume some additional licensing fees to be paid?"

View full card
LEG10: Does the introduction of Structured telephone support (STS) for adult patients with chronic heart failure presume some additional licensing fees to be paid?
Method
Short Result

Importance: Unspecified

Transferability: Unspecified

Result card for LEG11: "What are the width, depth and length of the manufacturers guarantee?"

View full card
LEG11: What are the width, depth and length of the manufacturers guarantee?
Method
Short Result
Result

Importance: Important

Transferability: Unspecified

Regulation of the market

Result card for LEG12: "Is Structured telephone support (STS) for adult patients with chronic heart failure subject to price control?"

View full card
LEG12: Is Structured telephone support (STS) for adult patients with chronic heart failure subject to price control?
Method
Short Result
Result
Comment

Importance: Unspecified

Transferability: Unspecified

Result card for LEG13: "Is Structured telephone support (STS) for adult patients with chronic heart failure subject to acquisition regulation?"

View full card
LEG13: Is Structured telephone support (STS) for adult patients with chronic heart failure subject to acquisition regulation?
Method
Frame
Short Result
Result

Importance: Important

Transferability: Unspecified

Result card for LEG14: "Is the marketing of Structured telephone support (STS) for adult patients with chronic heart failure to the patients restricted?"

View full card
LEG14: Is the marketing of Structured telephone support (STS) for adult patients with chronic heart failure to the patients restricted?
Method
Frame
Short Result
Result

Importance: Important

Transferability: Unspecified

Legal regulation of novel/experimental techniques

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

View full 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?
Method
Short Result
Result

Importance: Critical

Transferability: Unspecified

Result card for LEG16: "How the liability issues are solved according to existing legislation?"

View full card
LEG16: How the liability issues are solved according to existing legislation?
Method
Frame
Short Result
Result

Importance: Critical

Transferability: Unspecified

Discussion

Structured telephone support ist not a single drug or device or intervention, but includes different aspects of care and organisational structure. Therefore the legal aspects extend the usual frame for drug or device intervention.

The structural basics like property rights, marketing authorisation, patent binding, registries, providers guarantee as well as reimbursement include some tricky legal expanding due to the fact that STS is a package of different providers using possible devices and infrastructure with different regulation aspects. There are i.e. data protection issues, property rights to follow for the used software, patent bindings for a used questionnare, marketing authorisation necessary for medical devices used, and reimbursement issues due to DRG regulation or within contract binding.

In terms of patient right the easiest part is the voluntary participation, because for STS the patient-participation is part of the phone call. Appropriate information is usually part of the package of STS and selfmanagement support within STS, and there is always the opportunity for the patient to ask back. The more tricky legal aspect is the acces to STS and who decides it on what purpose. STS is a healthcare service and not a strict intervention, which can lead to the interpretaion of ”team structure” with compliance required from the patient. Data protection to secure privacy aspects is clearly regulated, so for the use of phone lines and internet connections they have to be followed accordingly by the provider.

There are some uncertain legal aspects due to Cross border healthcare which are usually limited by language, funding aspects with no clear solutions elsewhere, reimbursement aspects with no clear solutions elsewhere, procurement issues, and data protection via normal telephone line. Sustainable business models need to have one central coordinator who coordinates the different legal requirements – like in a hospital setting.

 

References

 

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[28] WHO Library Cataloguing-in-Publication Data World Health Organization. Medical device regulations : global overview and guiding principles. 1.Equipment and supplies – legislation 2.Equipment and supplies – standards 3.Policy making 4.Risk management 5.Quality control I.Title. ISBN 92 4 154618 2. http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf (WHO, 25.6.2015)

[29] Ärztegesetz §53 Werbebeschränkung und Provisionsverbot; https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10011138 (25.6.2015)

[30] 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 */ http://eur-lex.europa.eu/legal-content/de/TXT/?uri=CELEX:52012SC0413 (25.6.2015)

[31] Good Practive Guidelines existing for Chronic Patients with Cardiovascular disease RTF – Regional Telemedicine Forum Deliverable D3.3 Final Draft – 11 November 2011 http://www.google.at/url?sa=t&rct=j&q=&esrc=s&source=web&cd=5&ved=0CEsQFjAE&url=http%3A%2F%2Fwww.auvergnecentrelimousin.eu%2Factualites%2Fdownload%2F693%2F595%2F16&ei=7uaLVZKSA-K_ywOBzoC4Aw&usg=AFQjCNEEevcUZTQgF0F5GcByGdfZyDaDJA (25.6.2015)

[32] OECD (2013), ICTs and the Health Sector.: Towards Smarter Health andWellness Models, OECD Publishing. http://dx.doi.org/10.1787/9789264202863-en (25.6.2015) OECD ICT_--75511ee6-a509-47a8-8eda-7b65f5ec73d7.pdf

[33] Dubner S, Auricchio A, Steinberg JS et al. ISHNE/EHRA expert consensus on remote monitoring of cardiovascular implantable electronic devices (CIEDs). Ann Noninvasive Electrocardiol 2012; 17(1):36-56.

[34] Hardisty AR, Peirce SC, Preece A et al. Bridging two translation gaps: a new informatics research agenda for telemonitoring of chronic disease. Int J Med Inform 2011; 80(10):734-44.

[35] Galbreath AD, Krasuski RA, Smith B et al. Long term health care and cost outcomes of disease management in a large, randomized, community based population with heart failure. Circulation 2004;110:3518-3526

[36] Staples P;  Earle W.   The nature of telephone nursing interventions in a heart failure clinic setting.  Canadian Journal of Cardiovascular Nursing.  18(4):27-33, 2008.

 

Appendices

Existing patents

Code

Name

Link

DISEASE MANAGEMENT SYSTEM USING PERSONALIZED EDUCATION, PATIENT SUPPORT COMMUNITY AND TELEMONITORING

WO2012071354 (A2) ― 2012-05-31

SANITAS INC [US]; PARTOVI NASER [US] 

http://worldwide.espacenet.com/publicationDetails/biblio?CC=WO&NR=2012071354&KC=&locale=de_EP&FT=E

TELEMEDICINE SYSTEM FOR REMOTE CONSULTATION, DIAGNOSIS AND MEDICAL TREATMENT SERVICES 

WO2014163475 (A1) ― 2014-10-09

ESPINOSA ESCALONA FERNANDO PABLO JOSÉ [MX]; IGLESIAS RAMOS CARLOS GUILLERMO [MX]; MORALES MEDEL ALAN [MX]  +

http://worldwide.espacenet.com/publicationDetails/biblio?CC=WO&NR=2014163475&KC=&locale=de_EP&FT=E

TELEMEDICINE METHOD FOR REAL-TIME REMOTE MONITORING OF MEDICAL PROCEDURES

WO2014094095 (A1) ― 2014-06-26

UNICAMP [BR]; UNIV ESTADUAL DO OESTE DO PARANÁ UNIOESTE [BR]; MACHADO RENATO BOBSIN [BR]; CHUNG WU FENG [BR]; LEE HUEI DIANA [BR]; COY CLÁUDIO SADDY RODRIGUEZ [BR]; FAGUNDES JO O JOSÉ [BR]; NUNES MACIEL JOYLAN [BR]; VOLTOLINI RICHARDSON FLORIANI [BR]; MALETZKE ANDRÉ GUSTAVO [BR]; LEAL RAQUEL FRANCO [BR]; AYRIZONO MARIA DE LOURDES SETSUKO [BR]

http://worldwide.espacenet.com/publicationDetails/biblio?CC=WO&NR=2014094095&KC=&locale=de_EP&FT=E

MODULAR TELEMEDICINE ENABLED CLINIC AND MEDICAL DIAGNOSTIC ASSISTANCE SYSTEMS

WO2014063162 (A1) ― 2014-04-24

TAWIL JACK [US]; TAWIL MARGARET [US]; SANDBERG DOV [US]  +

http://worldwide.espacenet.com/publicationDetails/biblio?CC=WO&NR=2014063162&KC=&locale=de_EP&FT=E

GRAPHICAL USER INTERFACES INCLUDING TOUCHPAD DRIVING INTERFACES FOR TELEMEDICINE DEVICES  

EP2852881 (A1) ― 2015-04-01

INTOUCH TECHNOLOGIES INC [US]; IROBOT CORP [US]  +

http://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=2852881&KC=&locale=de_EP&FT=E

Electrical household system performing telemedicine and/or telecare functions, and corresponding method  

EP2592508 (A1) ― 2013-05-15

INDESIT CO SPA [IT]  +

http://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=2592508&KC=&locale=de_EP&FT=E

MULTIFUNCTIONAL MEDICAL DEVICE FOR TELEMEDICINE APPLICATIONS

EP2630628 (A2) ― 2013-08-28

3M INNOVATIVE PROPERTIES CO [US]  + 

http://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=2630628&KC=&locale=de_EP&FT=E

METHOD FOR DERIVING AND EVALUATING CARDIOVASCULAR INFORMATION FROM CURVES OF THE CARDIAC CURRENT, IN PARTICULAR FOR APPLICATIONS IN TELEMEDICINE  

EP2059163 (A2) ― 2009-05-20

TELOZO GMBH [AT]

http://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=2059163&KC=&locale=de_EP&FT=E

METER WITH INTEGRATED DATABASE AND SIMPLIFIED TELEMEDICINE CAPABILITY

EP1237463 (A1) ― 2002-09-11

BECKMAN COULTER INC [US] 

http://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=1237463&KC=&locale=de_EP&FT=E

TELEMEDICINE WEIGHING SCALE

EP1121574 (A1) ― 2001-08-08

HEWLETT PACKARD CO [US]

http://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=1121574&KC=&locale=de_EP&FT=E

PORTABLE TELEMEDICINE DEVICE

EP1011420 (A1) ― 2000-06-28

ORTIVUS AKTIEBOLAG [SE]

http://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=1011420&KC=&locale=de_EP&FT=E

 

T 0609/09 (Telemedical expert service provision/VISICU) of 22.1.2013

 

 

 

http://www.epo.org/law-practice/case-law-appeals/recent/t090609eu1.html

 

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