Issue link: http://www.e-digitaleditions.com/i/932381
health (see Table 2). Along with the benefits, however, come new challenges, such as potential increases in cost of treatments, fear of penalties for lack of adherence, additional burdens on the healthcare providers, poten- tial misuse of the data and vulnerabilities to hacking and privacy breaches. Legislators and regulators are stepping up to address these latter concerns in particular. A way forward is article provides an overview of the current (as of the end of 2017) regulatory landscape in the areas of patient data privacy and medical device cybersecurity. e arti- cle's focus is on the United States (US) and European Union (EU), as these world regions have issued the most detailed requirements and expectations to date, although many other countries have, or are developing, their own laws in this field. In addition to govern- ment-issued rules and regulations, various standard-set- ting bodies publish technical guidelines that may be applicable to digital products in general, including in a healthcare setting (e.g., the International Organization for Standardization, the Institute of Electrical and Elec- tronic Engineers (IEEE), the International Electrotech- nical Commission and others). Note that the title of a standard need not include the words "digital" or "cyber- security" to be applicable in this field. For example, standard ISO 13485, focused on Quality Management Systems, 12 expands the concept of risk management, which may be interpreted as including risks related to cybersecurity. Compliance with the ISO, IEEE and other international standards may be optional or man- datory, depending on the jurisdiction. gies (see Table 1) offer varying functionalities, ranging from simple dose counting and local weather alerts, to mobile apps reminding patients to take their medica- tion or tracking their asthma triggers. Moreover, inhal- ers with GPS sensors or wearable devices are able to provide the exact time and GPS location of a patient's asthma attack. Concerns In step with all these technological developments, soci- ety's sensitivity to the ownership of patients' data is also rising; just as the role of patients as the rightful focus and center of any medical program or product develop- ment is coming to the forefront of public's conscious- ness. 6-9 is drive towards patient-centric medicine may influence the interpretation of existing, and the emer- gence of new, regulatory and legal requirements related to "digital health." e concerns already raised at the federal level (in the US) and therefore the potential direction of future regulations can be surmised from the 2016 report by the US Department of Health and Human Services (HHS) 10 and the 2017 inter-agency report by the Task Force created by the US Congress. 11 e current data explosion is manifested not only in the volume and scale of gathered and stored data, but also in the velocity with which these data move, the variety of data sources, the multitude of potential venues where such data may be used and the emerging tendency to combine information contained in various centralized databases. Taken together, all these data create a won- derful opportunity for optimizing treatments, improv- ing adherence, minimizing medical errors, supporting healthy lifestyle choices and contributing to better Domain Examples Device performance • Dose counting • End-of-unit digital indicator • Coordination of actuation with the patient's breathing • Step-by-step instructions in real time on the use of the device Patient's behavior and health status • Reminder to take a dose • Record of patient's use information and sharing it with third parties (e.g., health- care provider) • Record of exact time and GPS location of a patient's symptoms exacerbation, and sharing these data with third parties Education and general information • Local alerts, such as high pollen count and pollution • Training resources (visual aids, videos, online chats with trained staff) • Community support (e.g., emailed newsletters, information about local meetings) • Announcements of relevant products and service information Table 1 Some Examples of Functionalities Offered by "Smart" Inhalers and Add-ons Inhalation February 2018 17