Legal and organizational aspects of remote cardiac monitoring: the example of implantable cardioverter defibrillators

REVIEW Europace (2012) 14, 1230–1235 doi:10.1093/europace/eus004 Legal and organizational aspects of remote cardiac monitoring: the example of impla...
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REVIEW

Europace (2012) 14, 1230–1235 doi:10.1093/europace/eus004

Legal and organizational aspects of remote cardiac monitoring: the example of implantable cardioverter defibrillators Imgard Vinck 1*, Chris De Laet 1, Serge Stroobandt 1, and Hans Van Brabandt 1,2 1 Belgian Healthcare Knowledge Centre (KCE), Kruidtuinlaan 55, B-1000 Brussel, Belgium; and 2Belgian Healthcare Knowledge Centre (KCE), Centre for Evidence Based Medicine (CEBAM), Kruidtuinlaan 55, B-1000 Brussel, Belgium

Received 5 July 2011; accepted after revision 30 December 2011; online publish-ahead-of-print 15 February 2012

The remote monitoring of implantable cardioverter defibrillators (ICDs) recently emerged as an attractive technological innovation that proved to be reasonably safe in partially replacing the in-clinic follow-ups of ICD patients with no or only mild symptoms. Apart from the fact that strong evidence about any additional clinical benefits and/or cost-efficiency are still awaited, legal and organizational hurdles remain in place, hampering any possibility for adoption of remote cardiac monitoring. This paper identifies a number of legal and organizational constraints which urgently need to be addressed. An elaboration of the specific juridical guidance for the interpretation and application of the relevant legislation is called for.

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Implantable cardiac defibrillator † Remote monitoring † Liability † Legal

Introduction Implantable cardioverter defibrillators (ICDs) are batterypowered, programmable electronic medical devices used for terminating life-threatening ventricular arrhythmias and hence preventing sudden cardiac death (SCD). Regular follow-up of the ICD patient is required for many reasons, including checking the device integrity, interrogation of the device for recorded arrhythmias, reprogramming of the device, clinical examination of the patient, and change in the patient’s medication based on those findings. Remote follow-up now allows ICDs to transmit on a regular basis system integrity and episode data to a data centre by making use of a fixed telephone line or mobile phone technology. Physicians can access thus data through a web application and assess the real need for an in-clinic visit and thereby potentially avoid an unnecessary visit. Remote monitoring also allows for the early detection of arrhythmia episodes or device integrity problems such as low battery voltage. Although there is limited evidence on direct patient benefits, mainly because of the poor quality and/or the small scale of the respective studies, this may change in the near future because of many ongoing major studies.1,2 The challenge is, however, not only to use remote monitoring for appropriate medical purposes, but the successful implementation will undoubtedly depend on its integration in an

adequate organizational and legal framework. The Belgian Healthcare Knowledge Centre investigated the legal and organizational issues raised by this emerging technology through a health technology assessment.1

Remote cardiac monitoring service and its applications Acquisition and transfer of remote monitoring has been extensively explained before.3 – 5 Several areas of application for the remote monitoring technology can be distinguished according to the purpose. This distinction is important since the organizational and the legal framework may differ according to the specific features. For the purpose of this research on remote monitoring of ICD devices we classified these as † Remote monitoring (strictu sensu) for regular follow-up: Automatic transmission of device data on a regular basis (daily, weekly, etc.) with an automatic triage system allowing the physician to be informed of any pre-defined events being alerts for arrhythmia episodes or alerts for system integrity (both for the device and lead system).

* Corresponding author. Tel: +32 2 287 33 38; fax: +32 2287 33 85, Email: [email protected] Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2012. For permissions please email: [email protected].

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† Follow-up replacement: Physician initiated (or pre-planned) device data transmission either as an alternative for a face to face follow-up or to prepare for the regular in clinic follow-up visit. † Alert triggering: Data transmission either patient initiated when problems are suspected based on symptoms or device initiated when pre-specified events trigger alerts that the ICD will communicate to the transmitter immediately.

monitoring is considered to be (but) one of the multiple eHealth applications.17 Since there is a mass of heterogeneous applications covering a range of particular needs, it is difficult to create a regulatory framework applicable to each specific individual case. Hence, we will focus on the applicability and the impact of existing general regulations affecting the particular issue of remote monitoring.

Liability

Legal framework Several issues related to remote cardiac monitoring raise legal concerns from the perspective of the multitude of intervening parties characterizing the remote monitoring service. The follow-up tasks are in general performed through the teamwork of several distinct healthcare personnel, being the electrophysiologist, the treating cardiologist, technician nurses as well as the manufacturer representatives, also called the industry employed allied professionals.6 Moreover, compared with classical treatments, not only healthcare professionals are involved in the remote monitoring chain, non-medical staff such as technical members and administrative staff also take part in the delivery of remote monitoring care. Furthermore, device suppliers, organizations that provide some kind of communication service, storage service or processing service, or a combination can be part of the remote monitoring trajectory. In principle, all these parties’ liability can be involved if damage has been caused to a patient or any other affected party by the service or product they offer.7 In the scope of remote monitoring, however, the professional liability of the physician seems to be the most critical one since the application of the general liability rules to this particular issue urges for interpretation. Hence we limit ourselves to develop this particular target group’s liability. In the second part of the section on the legal framework, the confidentiality of the data and privacy of the patient will be discussed. Although the respective legislation has implications for several organizational elements, these will solely be touched upon in the legal part.

Competences in regulating remote (cardiac) monitoring European Union (EU) action in the area of public health must fully respect the competencies of the Member States in healthcare (art. 168 Treaty of Lisbon8). Owing to this legal constraint, EU level initiatives in the telemedicine area are expressed in non-binding terms.9 Yet, there are several (binding) EU directives that are only indirectly linked to remote monitoring but they do have a direct impact, such as the liability regulations for defective products which applies to defective monitoring equipment.10 – 19 Since public health largely falls into the Member States’ competence, the corresponding legislative framework differs between Member States. The problematic issues raised in the next sections are, however, rather common for each Member State even if modalities in legislation differ. We opted to illustrate the Belgian legal framework and its application to remote monitoring. There is no custom-made regulatory framework specifically targeted at the implementation of remote monitoring in Belgium. This is not surprising since remote

Professional liability of the physician Remote cardiac monitoring, being an emerging technology, raises particular liability questions. Do physicians risk liability for omitting remote monitoring? What if the physician misses an alert and the patient dies? Today, the answers to these questions are often unclear because the general legislation remains too vague in its application to emerging technologies such as remote cardiac monitoring. This can lead to defensive behaviour of physicians, being on the one hand the refusal to apply remote monitoring for fear of liability for damage caused by the application modalities or on the other hand, the systematic application of remote cardiac monitoring, although not evidence-based, for fear of liability claims for having omitted remote cardiac monitoring. Choice of remote cardiac monitoring as therapy support: should patients be informed on the existence of remote monitoring as part of the aftercare? It is generally accepted that a surgeon is responsible for the aftercare linked to an intervention.20 Particularly relevant for remote cardiac monitoring is the duty to inform the patient about the aftercare required. Remote monitoring can be considered as a possible support in the aftercare follow-up of ICD-implanted patients. The duty to inform the patient on different alternatives merely depends on the risks and the efficiency of the particular intervention.21 On the one hand early notification of (clinical or device-related) problems by the remote monitoring application can prevent harm or can even be life-saving for some individual patients (e.g. early detection of lead fracture). On the other hand, overall, there is limited evidence on direct patient benefits although this might change rapidly in the near future due to many ongoing studies.1 One should also take into account potential false-positive alerts which are likely to cause anxiety with patients and can result in useless consults or admissions at the hospital. On the other hand, risks for the patients’ health in the remote monitoring application are limited. As long as there is no sound evidence on the clinical effectiveness it is doubtful if physicians can be held liable for omitting to inform patients suffering from particular cardiac conditions on the remote monitoring technique as an alternative way of follow-up. In order to prevent defensive (and inappropriate) behaviour by physicians fearing liability, guidelines should be elaborated for physicians how to deal with (this) emerging technology. These guidelines do not solely serve as guiding tools for physicians but can also be used as interpretative documents in legal cases, which enhances legal certainty for physicians.22 Informed consent: what should be disclosed to a patient in the remote monitoring application? Providing healthcare remotely does not alter a physician’s duty to inform the patient about a proposed treatment or procedure and

1232 obtain consent. According to the well-established informed consent principles set by legislation and jurisprudence, a physician may be held liable in negligence if he fails to disclose information to the patient so that the patient can make an informed choice.23 – 26 The most stringent question regarding patient information relates to the content. What should be disclosed to a patient in the remote monitoring application? Until today there is no clear answer to this question in doctrine or in jurisprudence. General legislation on informed consent defines a non-exhaustive list of information elements (the alternatives, the risks, the frequency, etc.) (art. 8 § 2 Patients’ Rights Act.27). In addition, it requires that all relevant information is disclosed to the patient. For the remote monitoring application some specific and essential information elements can be listed. First, it is of utmost importance to inform the patients on the limitations of the system. Burri and Senouf3 mentions the fact that remote monitoring should not be presented as an emergency service, or that the absence of a 24/ 24 permanence dealing with alert events should be stressed. In addition, system-specific features need to be explained. While some systems perform a daily transmission, some other systems are based on scheduled follow-ups only (typically 3 months) unless there are specific device alerts. Possible technical and functional limitations such as the lack in mobile network coverage should be mentioned. Moreover, the required patient input and the appropriate use of the monitoring system should be clarified (for instance, the patient will have to plug in the bedside monitor or needs to be in the proximity of the bedside monitor when the data are transferred from the device). A clear manual can be a supportive tool in addition to the oral information. If the patient omitted to follow the instructions, the physician can defend himself by stating that the damage was (partly) caused by the patient. It has to be noted that the current remote monitoring systems provide a back-up system and report if there was (for whatever reason) no transmission within a predefined period (typically 2 weeks). In principle, informed consent to the use of the remote monitoring system can be given orally. Written informed consent is possible on patient’s or physician’s demand (art. 8 § 4 Patients’ Rights Act27). It is recommended, however, in terms of transparency, organization and centralization of the information, to integrate information elements regarding processing of data revealed by the remote monitoring application as well as the information linked to the remote monitoring as medical intervention in one single document.28 As remote cardiac monitoring often involves a cross-border aspect (e.g. patient located in Member State X, service providers in Member State Y), the competent court of jurisdiction and the definition of which Member State’s law judges need to apply in liability cases should be specified. As mentioned before, there is no harmonized legal framework regulating healthcare services on the EU level. Patients can thus be confronted with slight differences in national legislation. For data protection legislation for instance, in principle the applicable Member State’s data protection law is usually the law of the Member State where the data controller is established. This solution is not very patient-friendly in cross-border situations. If their rights are infringed in another Member State than their home country, they will often be forced to exercise their rights in the

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data processors’ Member State and thus overcome all possible barriers related to, e.g. language, legal assistance, etc.29 Continuity of care: what if the physician misses an alert? Although it can be argued that in principle physicians are not obliged to apply remote monitoring, as far as today it cannot be considered to be the standard of care, certain duties arise once a physician has decided to make use of it. A particular problem related to the application of remote monitoring is the assurance of the continuity of care to the eligible patients. When prespecified events trigger alerts, the ICD will attempt to communicate to the transmitter immediately. What if the physician misses an alert and the patient dies (or other damage occurs)? In principle, physicians are obliged to ensure the continuity of care for any treatment, including the post-operative follow-up (art. 8 Royal Decree nr. 7820,30,31). In that scope they need to take all necessary measures to guarantee the appropriate quality of care to their patients during their absence. Question arises regarding to what extent 24 h assistance should be organized to respond to these alerts. It is important to distinguish remote cardiac monitoring for regular follow-up and the alert triggering system. For the regular follow-up, it is important to inform the patient that the remote monitoring service is not an emergency system and that it is up to the patient to contact the emergency services in case of emergency; that the transferred information will only be viewed within a specific delay and during specified hours (for instance office hours and not during the weekend). However, if alert systems are used the physician needs to make sure that short-term reaction is assured within the reasonable organizational limits and that backup is assured in case of longer periods of absence. Despite the concerns of physicians to be deluged with alerts, the actual event rate is only 0.86 alerts (clinical alerts as well as device integrity alerts) on average per 100 patients daily, which makes an on-call system between colleagues of the same specialty an option.32 Guidelines and corresponding service level agreements regarding the maximum response time for alerts and protocols regarding the assurance of continuity (who should organize the guards, status of the physician during on-guard time, etc.) should be elaborated to enhance medical and legal certainty for patients and physicians. Until then it is of an utmost importance to specify these organizational elements in a care agreement between the physician or the telemetric centre and the patient. It has to be noted that none of the manufacturers is claiming capabilities for offering emergency services response. It might be assumed that this responsibility is being avoided out of fear for liability litigations. Today, manufacturers tend to limit or exclude liability by adopting contractual clauses stating that the remote monitoring system in general (the alert function included) is not an emergency system and that patients should rely on the system accordingly. The validity of these clauses is questionable when the alert function can ‘de facto’ be conceived as an emergency tool. Even if the service is offered for free to patients, manufacturers are obliged to comply with legal standards.

Data protection and privacy Standards for data protection for all sectors, where personal data are processed, including personal health information, are mainly set

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by (binding) European legislation and are implemented in the European Member States.33 Consequently, national data protection legislation of the Member States will only moderately differ. Processing of patients’ health data applies to different steps in the trajectory of remote cardiac monitoring. For instance, the data transfer from the bedside monitor to the server as well as the consultation of the data by the treating physician (or other persons having access to the data) is perceived as data processing to which the dispositions of the privacy legislation apply. Several duties, rights, and responsibilities are linked to the different roles defined in the Belgian Data Protection Act (DPA), that transposed the European Data Protection Directive: the data controller who is basically the main responsible party for the set-up of the data processing; the data processor who performs the processing; and the data subject, the patient or the physician, depending on whose data are involved.34,35 Data subjects have to be informed about the processing of their personal data. The law specifies several information elements that have to be communicated in writing to the patient, such as the name and the address of the controller or his representative, the purpose(s) of the processing and the recipient(s) of the data. Other data subjects’ rights defined in the DPA are the right to access and the right to correct data or erase data, or object to processing. To enhance clarity and transparency, the identification of the different parties involved in the remote monitoring trajectory as well as their roles and responsibilities should be noted in the informed consent form. The data controller must implement appropriate technical and organizational measures to guarantee that the personal data are kept secured.36 Particular protection should be granted as far as unauthorized disclosure or access is concerned, accidental or unlawful destruction or accidental loss, alteration, and unauthorized disclosure or access. Examples of technical measures are backups, restricted access to the database to authorized persons, use of software with stringent security requirements.37,38 Furthermore, transfers to a data processor must be secured by a data processing agreement between the controller and the processor, which must meet a number of minimum requirements. A standard contract has been published by the European Committee for Standardization. Health data in the remote monitoring application will be regularly transferred to other Member States since the server to which data from the bedside monitor are sent is often located in another country than the patient’s home country. With regard to the transfer of data between Member States, the protection of data will in principle be performed correctly, since the receiving Member State will have to provide a similar level of protection of personal data according to the European Data Protection Directive. If data are transferred to the third countries, the Data Protection Directive stipulates that the Member State shall provide that the transfer of personal data that are undergoing processing ensures an adequate level of protection. Since personal data are often transferred between the EU and the USA, the US Department of Commerce issued the ‘Safe Harbour Principles’ in order to clarify the notion of adequacy.39 These principles have been recognized by the European Commission.40 For those countries where there is no adequate

level of protection, a transfer may take place on the condition that, e.g. the data subject unambiguously consented to the proposed transfer. A Member State may also authorize such a transfer if the controller adduced adequate safeguards with respect to the protection of the privacy, and fundamental rights and freedoms of individuals through appropriate contractual clauses.

Confidentiality Pursuant to legislation, doctrine, jurisprudence, and codes of ethics, physicians have the duty of confidentiality to their patients: they should not disclose patients’ health data to a third party.41 – 46 This duty applies to the remote monitoring practice no differently than to traditional practice. Yet, health data within the remote monitoring application can be shared between the treating physician, his/her (para)medical team and the referring physician if the addressee of the information is also bound by the duty of professional secrecy; if the sharing of the confidential information is necessary to ensure continuity and quality of care and if the patient has given his explicit or tacit consent or if the disclosure is in his/her best interest (shared professional secrecy).45 The necessity of the intervention of information and communications technology staff and other experts in the treatment of personal data of the patient necessitates considering them as ‘collaborators’ of the healthcare professionals and thus justifies the sharing of certain secrets in accordance with the theory of shared professional secrecy.47

Reimbursement of remote cardiac monitoring Legal obstacles for reimbursement in Belgium Today, in some European countries (Finland, Germany, Sweden, and the UK) remote follow-up replacing part of the in-clinic follow-up is reimbursed similarly to in-clinic follow-up. In Belgium, none of the remote monitoring applications is currently reimbursed by the Belgian compulsory health insurance. The monitoring equipment and the supporting services are currently not reimbursed in any of the European countries (in France, price premiums are granted on ICD for Biotronik). Legally, the reimbursement of telemedicine in general is problematic in Belgium, since the physical presence of the physician is required for the reimbursement of medical interventions (art. 1 § 4bis Royal Decree regarding the nomenclature).48 It is questionable, however, if the criterion of physical presence of the physician for reimbursement of medical interventions violates the European Community law, in particular if this is presumed to be an obstacle to the free movement of services. It is likely that the reimbursement of certain types of telemedical interventions will have to be accepted under Community law if the safety of the patient is guaranteed and if the telemedical treatment is cost neutral.49

Remote monitoring as a marketing tool Currently, companies mostly provide the remote monitoring service for free as part of their marketing policy. The systematic

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provision of this service for free may be illegal according to Belgian legislation since this can be considered as a financial benefit or a benefit ‘in natura’ to hospitals or prescribers, delivering or administering ICDs (art. 10 § 7 Law on Pharmaceuticals of 25 March 196450). Indeed, these hospitals or physicians are able to offer a service to patients that other hospitals cannot offer, which renders those more attractive to patients.

and needs imperatively to be accompanied by a system of additional pre-defined evidence gathering.

Reimbursement options for the future

Conflict of interest: none declared.

Once sufficient indications of efficacy and safety are available, conditional reimbursement of remote monitoring, irrespective of the medical application, could be considered but needs imperatively to be accompanied by a system of additional pre-defined evidence gathering. When the necessary evidence would be available, such a reimbursement could be integrated in a convention between the third-party payer (in Belgium: RIZIV/INAMI) and the hospital performing the regular follow-up and/or the remote monitoring, or remote follow-up. If, in the future, benefits for patients would be clearly demonstrated, the remote monitoring application urges to develop new financing mechanisms. These should not only cover care delivered at one specific moment and place, but also patient care and monitoring that occur remotely and over longer time periods. According to the workload (and thus the frequency of data reviewing) for the physician (or other clinical allied professionals) the reimbursement for remote follow-up replacing in-clinic follow-up should be distinguished from the reimbursement of remote monitoring for regular follow-up. An option for remote monitoring for regular follow-up is to pay a flat fee per patient per time unit (day, month, year, etc.). If remote follow-up replaces part of the in-clinic follow-up, a fee-for-service system where the remote follow-up is reimbursed up to the same level as the in-clinic follow-up could be considered. The problem is that the number of additional in-clinic unscheduled follow-ups may increase because of, for instance, the remote reporting of arrhythmic episodes. One could argue, however, that because of the presumed time gained by replacing (partly) the routine in-clinic follow-up with remote monitoring,51 the extra money for the remote follow-up could compensate for the additional work resulting from unscheduled follow-ups. Moreover, the time gained with the remote follow-up could be spent on other medical activities generating extra income. If reimbursement of remote monitoring or remote follow-up replacing in-clinic follow-up is considered, incentives for the referring physicians could be considered to stimulate an adequate referral policy.

Conclusion Legal and organizational hurdles are currently hampering the adoption of remote cardiac monitoring by today’s healthcare system. Hence, specific juridical guidance for the interpretation and application of the relevant legislation should be elaborated. As long as benefits for the patient or the healthcare system are not clearly demonstrated, regular reimbursement for remote monitoring should be refrained from. Conditional reimbursement of remote monitoring irrespective of the medical application can be an option once there are sufficient indications of efficacy and safety,

Acknowledgements Many thanks are addressed to our colleagues Carine Van de Voorde and France Vrijens for their careful reading and useful feedback on this paper.

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