**4. Conclusion**

**3.4. Limits of telecardiology**

100 Cardiac Defibrillation

A network failure may delay transfer of data. Most of telecardiology departments do not have 24/7services. Thus, an alert message issued on a Friday night has a good chance not to be examined before the following Monday. In addition transferred data through the net‐ work are privileged, leading to legal considerations regarding reliability of the technology and confidentiality especially during emergency situations. To add another level of com‐

Health care providers and health care organizations that are involved in remote monitoring (RM) of ICDs will typically sign a 'Terms of Use' agreement with each of the ICD vendors. These legal documents outline the provisions of RM between the ICD vendor and the user. The patient needs to be informed of the purpose and limitations of RM, such as the fact that it does not replace an emergency service or absence of dealing with alert events outside of‐ fice hours. Before initiating RM and follow-up, the patient may be requested to sign a writ‐ ten informed consent stating these points and authorizing transmission of personal data to third parties, respect of privacy, and confidentiality of patient data by device companies should be subjected to strict rules, described in contracts. Cardiac implantable devices re‐ cord a wealth of information and as devices become more sophisticated the scope of infor‐ mation can be expected to grow. Guidelines need to be established to determine the periodicity with which ICD transmissions would need to be reviewed and documented.

Vulnerability of security breaches by hackers accessing devices with wireless capability must be tested in every system. There have been no reports to date of unauthorized reprog‐ ramming of implantable devices; however, unauthorized access to personal information

In addition, transfer of ICD data would be impossible if the home monitoring station is not close to the patient at reasonable time intervals. This could be happening in case of hospitali‐ zation in another center. The patient could even experience serious system failure without

Logistics may also be a limit to the development of home monitoring: It is up to the implant‐ ing center to organize ordering, stock management and traceability of home monitoring sta‐ tions as well as patient education. The Sorin group is the only one so far using a distribution

Reimbursement is important to the manufacturer in order to compensate for some of the costs related to the home monitoring stations and the transmission network. It remains a major con‐ cern in most countries, limiting the increase of use of remote monitoring despite growing evi‐ dence in favor of this technology. Today's cost containment pressure requires increased reimbursement efforts with the burden of proof shifting to medical communities and manufac‐ turers. Reimbursement assessments often begin with the presumption that a technology or service will not be covered unless its use is supported by scientific evidence of improved out‐ comes. Recent publications like the EVOLVO study [37] are important milestones in this en‐

stored on internet servers must be also considered.

any data transmission.

**3.5. Reimbursement**

network to handle all these tasks.

plexity, each country seems to have a different modus operandi at this point in time.

Remote monitoring of ICDs represents a growing area with increasing numbers of patients being subject to these technologies but also more and more physicians involved in decision making on the indications for these technologies and the handling of data in the context of clinical decision making.

Cardiac implantable device transmissions may occur either over telephone lines or over cel‐ lular network lines. These transmissions often only take less than a minute to a few minutes to complete. However, in the foreseeable future we can expect alternative methods of data transmission to become available with transmission rates that will make it possible for near‐ ly continuous and instantaneous patient ICD data delivered to health care providers. There are, of course, limitations to how frequently ICD data can be reviewed by health care pro‐ viders and battery longevity constraints will likely limit the transmission times as well.

Technological advancements continue to structure our practice of medicine, but with it often new legal challenges emerge. In order to minimize risk to patient and liability to health care providers a clear discussion regarding the expectations and limitations of remote monitor‐ ing between patients and health care providers is recommended
