It is answered within the CUR domain, we did not do it twice.

See CUR 15

 This question is answered within the CUR domain, we did not do it twice.

Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts. The document was searched for „property right“ and „intellectual“, articles includig these terms are listed.

A Search was done within the EPO – European Patents registration using the keywords „telemedicine“ and „telemonitoring“

Agreement on Trade-Related Aspects of Intellectual Property Rights The TRIPS Agreement is Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994.

According to the Directive 2004/18/EC {2} 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.

Within the patent database EPO – European Patents registration {5} one document was found about Telemedical expert service provision for „telemedicine“ / „telemonitoring“, which seems to be an ongoing negotiation, and several other documents about disease management systems, telemedicine systems, interfaces, corresponding methods, etc. This as a result of the legal aspects means, that a provider is on the saver side when checking for patents before implementing STS as telemonitoring. There might be some features not allowed to be copied.

There are some companies providing a full package of telemonitoring including structured telephone interview. If STS is planned to be implemented, the provider has to be aware of possible patents, especially for a certain structure and/or the implemented questionnaire and the risk-calculation-model.

The use of a patent-binded source (or parts out of it) without permission could result in penal costs.

A search within the patent database can help to find out existing patents.

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, and be in line with the Directive 2004/18/EC.

1. Patents (search in EPO {5}. A list of possible relevant patents is provided in appendix 1. This list is not exhaustive! (links checked on 13th May 2015)

General provisions

• Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts {2}

This applies to public contracts concluded by a contracting authority in sectors for: supplies services; and public work contracts. It depends on the context of the provision of structured telephone support for patients with chronic heart failure whether this directive has to be taken into account.

Art 30 (c) ”...in the case of services, inter alia services within category 6 of Annex II A, and intellectual services such as services involving the design of works, insofar as the nature of the services to be provided is such that contract specifications cannot be established with sufficient precision to permit the award of the contract by selection of the best tender according to the rules governing open or restricted procedures“

• The TRIPS Agreement is Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994. {4}

TRIPS in connection to telemonitoring/ telemedicine could be relevant for the definitions and interventions listed in TEC_5 (out of the studies from the basic search) (selected narratively):

Part II Article 9 (2)

”Copyright protection shall extend to expressions and not to ideas, procedures, methods of operation or mathematical concepts as such.”

Part II Article 10 (1)

”Computer programs, whether in source or object code, shall be protected as literary works under the Berne Convention (1971).”

Part II Article 10 (2)

”Compilations of data or other material, whether in machine readable or other form, which by reason of the selection or arrangement of their contents constitute intellectual creations shall be protected as such. Such protection, which shall not extend to the data or material itself, shall be without prejudice to any copyright subsisting in the data or material itself.”

Part II Article 27

According to Article 27 1. patents shall be available for any interventions, products and processes. But there is an option to exclude patentibility in 2.:

” 2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.”

”3. Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

Part II Article 31

”Where the law of a Member allows for other use (7) of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:”

”(h) the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;

(i) the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;

(j) any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;”

Convention on Human Rights and Biomedicine CETS No: 164 (including the Explanatory report to Biomedicine convention).

Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare

The Convention on Human Rights and Biomedicine includes 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. {6}

In a situation of cross-border healthcare (i.e. a patient was treated at a heart center in EU member state A and want’s to participate in the recommended telemonitoring by structured telephone support) a cross-border communication, transfer and/ or reimbursement can be the case. Then the regulations of data protection, data transfer and the need for prior authorisation have to be clarified. {7}

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. The voluntary participation is guaranteed with the will of cooperation.

General provisions

• Convention on Human Rights and Biomedicine CETS No: 164 (including the Explanatory report to Biomedicine convention) {6}

Chapter I – General provisions

Article 1 – Purpose and object

“Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine. Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.”

Article 2 – Primacy of the human being

“The interests and welfare of the human being shall prevail over the sole interest of society or science.”

Article 3 – Equitable access to health care

“Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality.”

Article 4 – Professional standards

“Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.”

Chapter II – Consent

Article 5 – General rule

“An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time.”

Chapter III – Private life and right to information

Article 10 – Private life and right to information

1. “Everyone has the right to respect for private life in relation to information about his or her health.
2. Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed.
3. In exceptional cases, restrictions may be placed by law on the exercise of the rights contained in paragraph 2 in the interests of the patient.”

• Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare. {7}

Chapter II Article 5 Responsibilities of the Member State of affiliation

“The Member State of affiliation shall ensure that:

1. 1. the cost of cross-border healthcare is reimbursed in accordance with Chapter III;
   2. there are mechanisms in place to provide patients on request with information on their rights and entitlements in that Member State relating to receiving cross-border healthcare, in particular as regards the terms and conditions for reimbursement of costs in accordance with Article 7(6) and procedures for accessing and determining those entitlements and for appeal and redress if patients consider that their rights have not been respected, in accordance with Article 9. In information about cross-border healthcare, a clear distinction shall be made between the rights which patients have by virtue of this Directive and rights arising from Regulation (EC) No 883/2004;
   3. where a patient has received cross-border healthcare and where medical follow-up proves necessary, the same medical follow-up is available as would have been if that healthcare had been provided on its territory;
   4. patients who seek to receive or do receive cross-border healthcare have remote access to or have at least a copy of their medical records, in conformity with, and subject to, national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC.”

Directives 95/46/EC regulates the data protection, 2002/58/EC regulates the processing of personal data and the protection of privacy in the electronic communications sector.

National contact points for Cross border healthcare can be found here: http://europa.eu/youreurope/citizens/health/help-from-the-pharmacy/prescription/index_en.htm#!lightbox-uid-0

• Important

Comment

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 {8}

[8] EUnetHTA Joint Action 2, Work Package 8. HTA Core Model ® version 2.1 (Pdf); 2015. Available from http://www.corehta.info/BrowseModel.aspx.

Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.

Recommendation R (97) 5 of the Committee of Ministers to Member States on the protection of medical data.

Structured telephone support provides a special topic for data security. The usual telephone line is usually not privacy protected.

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 an existing data protection regulation on EU-level {9}, which is already adapted and integrated in all of the countries in EU, Norway, Switzerland. {7} There are two additional recommendations for data protection of medical data {10} and protection of private data within telecommunication services {11} which have to be taken into account when implementing a telemonitoring service with STS.

There are clear regulations in data protection on EU level {9} which are adapted accordingly in the members states

• Directive (2011/24/EU) on Patients' Rights in Cross-border Healthcare states {7}: “(d) patients who seek to receive or do receive cross-border healthcare have remote access to or have at least a copy of their medical records, in conformity with, and subject to, national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC.”

• Recommendation R (97) 5 of the Committee of Ministers to Member States on the protection of medical data {10}:

“Recalling the general principles on data protection in the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (European Treaty Series, No. 108) and in particular its Article 6 which stipulates that personal data concerning health may not be processed automatically unless domestic law provides appropriate safeguards;

Aware of the increasing use of automatic processing of medical data by information systems, not only for medical care, medical research, hospital management and public health but also outside the health-care sector;”

The recommendation gives clear advice how to understand and act regarding to the protection of medical data.

Within the use of structured telephone support it is relatively easy to ask the patients’ agreement for data transmission and intended use.

• Recommendation No.R (95) 4 on the protection of personal data in the area of telecommunication services, with particular reference to telephone services {11}:

“2. Respect for privacy

2.1. Telecommunications services, and in particular telephone services which are being developed, should be offered with due respect for the privacy of users, the secrecy of the correspondence and the freedom of communication.

2.2. Network operators, service providers and equipment and software suppliers should exploit information technology for constructing and operating networks, equipment and software, in a way which ensures the privacy of users. Anonymous means of accessing the telecommunications network and services should be made available.

2.3. Unless authorised for technical storage or message transmission or for other legitimate purposes, or for the execution of a service contract with the subscriber, any interference by network operators or service providers with the content of communications should be prohibited. Subject to Principle 4.2 the data pertaining to the content of messages collected during any such interference should not be communicated to third parties.

2.4. Interference by public authorities with the content of a communication, including the use of listening or tapping devices or other means of surveillance or interception of communications, must be carried out only when this is provided for by law and constitutes a necessary measure in a democratic society in the interests of:

a. protecting state security, public safety, the monetary interests of the state or the suppression of criminal offences;

b. protecting the data subject or the rights and freedoms of others”

[...]

“4. Communication of data

4.1. Personal data collected and processed by network operators or service providers should not be communicated, unless the subscriber concerned has given in writing his express and informed consent and the information communicated does not make it possible to identify called parties. The subscriber may revoke his consent at any time but without retroactive effect.”

[...]

“6.1. Network operators and service providers should take all appropriate technical and organisational measures to ensure the physical and logical security of the network, services and the data which they collect and process, and to prevent unauthorised interference with, or interception of, communications.

6.2. Subscribers to telecommunications services should be informed about network security risks and methods for subscribers to reduce the security risks of their messages.”

[...]

“7.20. When providing and operating a mobile telephone service, network operators and service providers should inform subscribers of the risks for secrecy of correspondence which may accompany the use of mobile telephone networks, in particular in the absence of encryption of radiocommunications. Means of offering encryption possibilities or equivalent safeguards to subscribers to mobile telephone networks should be found.”

Theoretically, in case if no data security takes place, what were the consequences of unprotected data for the patient?

• Harm in dignity: propably no. Heart failure is usually not stigmatized
• Social harm: probably no. No one else will be directly affected by the heart failure of the patient
• Harm as decreased chances on market: Jobmarket - propably not for Persons aged 65+. Privat (health) insurance market - (higher contributions, refusal of contract) propably not in the age above 65
• Potential of misuse from the provider according to civil law (like purchased life annuity)

Theoretically, in case of too much data security or incompetent (no availability of results for other provider, i.e. the patients’ local GP) use of documented data, what are the consequences for the patient?

• results or suspicions are not available for other health care provider with could mean double examinations for the patient and/or missed information (i.e. overseen deterioration)
• missed advantages of provider-networking

The allocation of (limited) resources needs to select the most benefiting patients without discrimination. In case of structured telephone support for patients with chronic heart failure the decision process is to be made transparently and to follow objective indicators like regional distance, compliance, absence of relatives, etc. – despite the medicinal criteria.

The allocation of (limited) resources needs to select the most benefiting patients without discrimination. In case of structured telephone support for patients with chronic heart failure the decision process is to be made transparently and to follow objective indicators like regional distance, compliance, absence of relatives, etc. – despite the medicinal criteria.

• Convention for the Protection of Human Rights and Fundamental Freedoms {12}, 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.” {12}

• 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 {13,14,15,16,17,18,19}
• 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 ({12}, Article 14 – Prohibition of discrimination

There are several regulations and statements on EU- and international level for securing equal access to health care in Europe.{13,14,15,16,17,18,19} It implements that usual care for all persons is provided.

The limits of healthcare should be implemented in a balance between the right of access and the patients' right for human dignity, right to life, right to the integrity of the person, prohibition of torture and inhuman or degrading treatment or punishment; and respect for private and family Life. Transparency is one method to provide prohibition of discrimination as required in the Convention for the Protection of Human Rights {12}.

Especially in the field of e-health It is essential to discuss, among others, aspects relating to safety and confidentiality; professional accountability; technical standards relating to digital recording, storage, and transmission of clinical data; copyright; authorization from professional regulatory bodies; and licensing for the remote practice of medicine. (Rezende 2010) {20}

Responsibility:

Legal issues can be solved easily when responsibilities of parties concerned have been established and documented. Loeber 2008 {21}

• See LEG 3

Currently 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.

Cross border healthcare directive – relevant regulations see LEG 3

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

Please take the answer at TEC11

OECD ICT read for basic ideas within this AE [32]

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety.

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

Discussion

What kind of uncertainties are upcoming? Who is responsible for (what kind of ) safety?

• Safety challenge 1: data transfer (i.e. continuous telephone WLAN/ energy support guaranteed?) – compare with „usual care“ and „safe transport to the physician“
• Safety challenge 2: Identification and authentication (is the right patient on the phone? Are the documented data of the right patient?)
• Safety challenge 3: timely reaction in case of emergency – compare with „usual care“
• Safety challenge 4: Safety of the (medical) devices used by the patient at home (i.e. blood pressure device)

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”

Ad safety challenge 1 ”data transfer”)

There is the possibility that the WLAN system or the energy system brakes down (i.e. due to heavy storm or snow) and that the patient at home cannot reach for support. Compared to usual care there is no difference – in such a situation there would be no possibility to reach the physician by usual transport (i.e. car).

Ad safety challenge 2 ”identification and authentication”)

Via telephone there is an incraesed possibility to have a wrong authentication or identification of the patient, meaning that the health porvider calling does not necessarily know the voice to identify the patient correctly. This could lead to a misinterpretation of the communication, especially if compared to an existing (symptom-) trend.

This safety challenge should be easy to solve by re-asking the patients identiy in the beginning of the call by the provider. There are Identification and authentication challenges in hospital too, the rules and solutions how to cope with it (controlling/ cross-check, re-asking) can be adapted.

In a hospital the organisation is in duty for harms due to safety-failure-events. In a physicians practice the physician is in duty for the safety aspects. For structured telephone support it depends who is calling among what kind of organisation structure.

Ad safety challenge 3 ”timely reaction”)

The timely reaction to an upcoming deterioration or emergency situation could be different in the face-to-face contact compared to telephone contact. The advantage of the face-to-face contact is the additional visual aspect (i.e. to see certain symptoms like skin colour, sweat, leg-edemas). Structured telephone support works by trend and staff-experience. The responsibility for an undetected deterioration has to be solved within the working-contract of the health-provider. The role of the patient is unclear – does he/she have to report the symptoms correctly? Is he/she able to detect the symptoms correctly and to report uncertain signs? The face-to-face contact adds visual information even without correct symptom-reporting. A voice-recording system along the telephone-support-call could help to clarify such situations. In „usual“ care there has to be a kind of documentation system about the kind of treatment and care. This documentation should provide appropriate information about unclear responsibility. A documentation is also required for telephone support, and it provides safety awareness for both, patient and provider.

Ad safety challenge 4 ”devices safety”)

Medical devices:

• Have to follow the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices {22}
• The current legal provisions and the structure of Eudamed will not allow Eudamed to provide a complete picture of the EU market for medical devices, the number of devices entered is therefore not representative of the Union's medical device market {23}

Other devices:

• Have to follow Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety

Overlaps with patent binding. See LEG 2

See LEG 2

• We changed the word ”manufacturer” into ”provider” and looked at the duties of the providers of structured telephone support to guarantee appropriate quality
• Search for professional licencing regulations in the context of one member state (Austria) exemplarily

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. {25} The qualification requirements are regulated at national/regional level.

The qualification of the provider within the structured telephone support should be transparent and according to the national professional standards (i.e. medical professionals’ law/Medizinberufegesetz, physicians’ law/Ärztegesetz, law for healthcare professionals/Gesundheits- und Krankenpflegegesetz, etc., in Austria).

If a national registration for medical professionals is required it should be the same for the providers of the telephone support, especially if treatment advices are given or symptoms are collected and asked for. {1}

The patient should be informed about the identity and the profession of the person calling. (no legal requirement, content of patient information standards)

The documentation of the data within health records requires the identification of the healthcare provider (who did what, when and how)

Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts {2} 

Use of the common search results by the project manager for this HTA on STS for chronic heart failure patients:

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. {35}

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. {36}

STS for adult patients with chronic heart failure might be a subject to price control whenever the services included in STS fall under the public contracting legislation/ reimbursement schemes. This might happen in different degrees, up to various level. In a randomized, controlled clinical trial conducted in the U.S. {Galbreath} disease managers were employed by CorSolutions, Inc, which is an established disease management company and was contracted for the study to carry out the structured telephone support. In such case, the whole service would be contracted and subject to contracting.

Directive 2004/18/EC (11) defines »framework agreement" as an agreement between one or more contracting authorities and one or more economic operators, the purpose of which is to establish the terms governing contracts to be awarded during a given period, in particular with regard to price and, where appropriate, the quantity envisaged.

The criteria on which the contracting authorities base the award of public contracts can be either:

(a) various criteria e.g. quality, price,technical merit, aesthetic and functional characteristics, environmentalcharacteristics, running costs, cost-effectiveness, after-sales service and technical assistance, delivery date and delivery period or period ofcompletion, or

(b) the lowest price only.

[Directive 2004/18/EC, Article 53 1.]

Usually, however, for the STS an additional nurse was used who had access to patient data, carried out the STS, monitored the patient, recorded the symptoms and data and reinforced and adapted the plan of care for the patient. The other medical professions did not get involved in STS directly, only indirectly, through the STS nurse, who coordinated all the activities and services around the patient. No study specifically recorded the (decrease or increase of) workload for other specialists in case a STS nurse was involved in the work {Staples}.

In such cases, the medical personnel reimbursement remains a major concern with a lack of appropriate reimbursement in place in most countries worldwide and as a result less STS is introduced by providers {33}. As usual setting for STS is hospital (after patients are discharged from hospitals) it is to be expected that a specific DRG (or similar) needs to be formed to finance the STS service. As pricing is national level task, the national legislation applies and the only price control would be contracts conducted between the provider and payer in accordance with national health policy. 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).

STS for adult patients with chronic heart failure might be a subject to price control whenever the services included in STS fall under the public contracting legislation/ reimbursement schemes. This might happen in different degrees, up to various level. In a randomized, controlled clinical trial conducted in the U.S. {Galbreath} disease managers were employed by CorSolutions, Inc, which is an established disease management company and was contracted for the study to carry out the structured telephone support. In such case, the whole service would be contracted and subject to contracting.

Directive 2004/18/EC (11) defines »framework agreement" as an agreement between one or more contracting authorities and one or more economic operators, the purpose of which is to establish the terms governing contracts to be awarded during a given period, in particular with regard to price and, where appropriate, the quantity envisaged.

The criteria on which the contracting authorities base the award of public contracts can be either:

(a) various criteria e.g. quality, price,technical merit, aesthetic and functional characteristics, environmentalcharacteristics, running costs, cost-effectiveness, after-sales service and technical assistance, delivery date and delivery period or period ofcompletion, or

(b) the lowest price only.

[Directive 2004/18/EC, Article 53 1.]

Usually, however, for the STS an additional nurse was used who had access to patient data, carried out the STS, monitored the patient, recorded the symptoms and data and reinforced and adapted the plan of care for the patient. The other medical professions did not get involved in STS directly, only indirectly, through the STS nurse, who coordinated all the activities and services around the patient. No study specifically recorded the (decrease or increase of) workload for other specialists in case a STS nurse was involved in the work {Staples}.

In such cases, the medical personnel reimbursement remains a major concern with a lack of appropriate reimbursement in place in most countries worldwide and as a result less STS is introduced by providers {33}. As usual setting for STS is hospital (after patients are discharged from hospitals) it is to be expected that a specific DRG (or similar) needs to be formed to finance the STS service. As pricing is national level task, the national legislation applies and the only price control would be contracts conducted between the provider and payer in accordance with national health policy. 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).

• Critical
• Important
• Optional

(Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts.

Decision about which technology is provided?

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.

Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts {2}

For public services the Directive 2004/18/EC provides clear regulation for service exceeding an amount of € 162.000 or € 249.00 or € 6.242.000 (Art 7) for services not excluded from the regulation (Art 10, 11, 12, 18). Central purchasing bodies involvement is regulated within Art 11. Providing exploit public telecommunication networks or telecommunication services is excluded within Art 13. This Directive shall not apply to service concessions as defined in Article 1(4) (see Art 17). Article 44 regulates the choice of the participants and the follwoing articles regulate choice characteristics (personal, economic, suitability, pürofessional ability,quality, environment, operational certification, for the participating service contents or mechanisms (Art 45-52).

The Directive 2004/18/EC is possibly more detailed in respective/implemented national law. For Austria i.e. this would be the procurement law (Bundesvergabegesetz 2006) {26}

Directive 93/42/EEC of 14 June 1993 concerning medical devices.

National laws

For medical services the direct marketing towards the patient is always restricted due to the connection with health needs.

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.

Directive 93/42/EEC of 14 June 1993 {22} regulates the use of non-implantable medical devices. The rules have to be followed if such devices are used in combination with STS. (CE mark or at least information of the competent authorities is required for a certain class of medical devices).

Within the field of marketing of medical products/ services one should always be aware of the definition of corruption:

Illegality; a vicious and fraudulent intention to evade the prohibitions of the law. The act of an official or fiduciary person who unlawfully and wrongfully uses his station or character to procure some benefit for himself or for another person, contrary to duty and the rights of others. {27}

Advertisement has the potential to create expectations and powerfully influence the belief in a medical device’s capabilities. It is important, therefore, that medical device marketing and advertising are regulated to prevent misrepresentation of a medical device and its performance. (...) Whether to grant local marketing rights to a medical device remains a local government decision, which may rest on local socioeconomic considerations and technology assessment information. {28}

In Austria i.e the physicians’ law includes a paragraph about advertisement limitation and prohibition to earn a commission {29}

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 .

Decision No 1926/2006/EC of the European Parliament and of the Council of 18 December 2006 establishing a programme of Community action in the field of consumer policy (2007-2013)

Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (especially (4), (6), Art 13 (1., 3a, 3b).

used as basic documents for a

discussion with experts

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.

The 1926/29006/EC is used as a basic document, especially due to the aim (Art 2) for regulating the consumer aspects. Its not a regulation.

Directive 2001/20/EC was used as a basic document for the discussion due to the ”liability” of member states for any investigantional medicinal products.

The liability issues require a certain business plan for the provision of (any) tele-healthcare service, including telephone support.

This means that the patient has to have one single partner to be ”contracted” with. In the usual face-to-face contact with the primary care physician (general practitioner) the care-contract exists between the patient and the physician.

Within a telehealth-structure there are many possible contracts like telephone line company, energy support, software involved, the staff providing the telephone support, a possible company providing a package of structured support including telephone calls, the physician providing the data check/ medication change/other medical services, the server hosting company for the data storage, etc...

Within this structure there is an additional challenge in many countries, which implies a direct (face-to-face) medical care required from the phyiscian and/or other healtcare staff., and which is per definition not the case for any kind of telemedical service. Also the hospitals are responsible to provide the care within the hospital environment.

A national health system or a social insurance could be able to provide telemedicine as a ”service” meaning the provision of being the ”contract head” for all different included services (as listed above). The patient, the GP, the hospital, the software/telecom/other companies are contracted with the health system (national /community government, or social insurance) within a kind of structured program regulating the rights and duties of the contracted partners.

Such a service of the health system could be provided everywhere, even if the patient is abroad (i.e. for holidays), because it is not a direct medical treatment, but a service package including different aspects.

Hardisty et al.{34} point out that There is a fundamental lack of clarity regarding the location of decision making responsibility when the service is spread across multiple providers. This issue has not been addressed in work to date and may require changes in how services are designed and managed, impacting medico-legal frameworks.

The 1926/29006/EC is used as a basic document, especially due to the aim (Art 2) for regulating the consumer aspects. Its not a regulation.

Directive 2001/20/EC was used as a basic document for the discussion due to the ”liability” of member states for any investigantional medicinal products.

The liability issues require a certain business plan for the provision of (any) tele-healthcare service, including telephone support.

This means that the patient has to have one single partner to be ”contracted” with. In the usual face-to-face contact with the primary care physician (general practitioner) the care-contract exists between the patient and the physician.

Within a telehealth-structure there are many possible contracts like telephone line company, energy support, software involved, the staff providing the telephone support, a possible company providing a package of structured support including telephone calls, the physician providing the data check/ medication change/other medical services, the server hosting company for the data storage, etc...

Within this structure there is an additional challenge in many countries, which implies a direct (face-to-face) medical care required from the phyiscian and/or other healtcare staff., and which is per definition not the case for any kind of telemedical service. Also the hospitals are responsible to provide the care within the hospital environment.

A national health system or a social insurance could be able to provide telemedicine as a ”service” meaning the provision of being the ”contract head” for all different included services (as listed above). The patient, the GP, the hospital, the software/telecom/other companies are contracted with the health system (national /community government, or social insurance) within a kind of structured program regulating the rights and duties of the contracted partners.

Such a service of the health system could be provided everywhere, even if the patient is abroad (i.e. for holidays), because it is not a direct medical treatment, but a service package including different aspects.

Hardisty et al.{34} point out that There is a fundamental lack of clarity regarding the location of decision making responsibility when the service is spread across multiple providers. This issue has not been addressed in work to date and may require changes in how services are designed and managed, impacting medico-legal frameworks.