Ethics and the Cardiac Pacemaker: More Than Just End-of-life Issues

Katrina Hutchison; Robert Sparrow

Disclosures

Europace. 2018;20(5):739-746. 

In This Article

Remote Accessibility, Cyber Security, and Privacy

Cardiologists can now retrieve information about patients' cardiac function and pacemaker function, and reprogram pacemakers from afar. This saves clinicians' and patients' time by avoiding unnecessary follow-up visits. There is also evidence that it facilitates early identification of device faults and adverse events.[45]

However, remote access to cardiac devices also generates privacy and security issues. The storage of information poses questions about who will be authorised to access it. In addition to concerns about who should be authorised to access this information, there is also the risk of it being intercepted or wrongly delivered to those who are not authorised. Most manufacturers currently host the data on secure internet servers, where clinicians can login to access their patients' data. Some of these systems partly process the data, which ensures that clinicians are not overburdened with the task of scanning and interpreting large amounts of raw data on a daily basis.[46] In some countries data are monitored by employees of manufacturers rather than by clinicians.[47] Manufacturers also use data from pacemakers for quality control and design purposes. There is no reason to think that these activities will harm the patients whose data is used, and quality control measures and design improvements might benefit future patients. Nevertheless, there is a question about the right of companies to profit from such information. These issues are similar in many respects to ethical concerns about use of data stored in genetic databases, where private databases controlled by industry players raise particular concerns.[48]

Unauthorised access of devices inside patients by people within transmission range has also been raised as a potential risk. For example, ethical hackers have demonstrated the possibility of hacking a remotely accessible pacemaker and reprogramming it to give a lethal shock.[49] Similar concerns led doctors to disable the remote accessibility functions of Dick Cheney's cardiac implant while he was Vice President of the USA to ensure he wasn't vulnerable to an attack of this kind.[50] Identifying effective security measures that also allow health professionals access to the device in emergencies is challenging, especially as patient preferences differ.[51] Clinicians are most likely to confront these issues when patients raise concerns about device security. The hacking of cardiac devices has been the focus of news headlines and television drama storylines, both of which could cause anxiety in some patients. Awareness of these issues can inform device selection and programming, as well as the advice clinicians give to individual patients. The questions listed in Table 4 may be useful in guiding device selection for individual patients.

Whereas professional bodies have developed consensus recommendations for issues such as device deactivation and interaction with industry, there is no equivalent resource outlining the issues arising from functions that enable remote monitoring and data collection.[1,3,12,28] Although such resources are not a magic bullet, it might nevertheless be valuable for the profession to work to develop a consensus statement or set of recommendations as a resource to help clinicians navigate these emerging concerns.

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