Issue link: http://www.e-digitaleditions.com/i/932381
Proliferation of products, applications and services that collect personal and health-related information is giving rise to a new set of regulatory rules and requirements. 16 February 2018 Inhalation Regulatory considerations for cybersecurity and data privacy in digital health and medical applications and products Proliferation of products, applications and services that collect personal and health-related information is giving rise to a new set of regulatory rules and requirements Svetlana Lyapustina, PhD and Katherine Armstrong, JD Drinker Biddle & Reath, LLP Medical, in which study participants will download the Apple Heart Study App, and the Apple Watch's heart rate sensor will collect data on irregular heart rhythms and receive a notification if irregular heart rhythms are identified. 2 As another illustration, the United States Food and Drug Administration (FDA) recently approved a pill that digitally tracks whether patients have taken their medication. is is the first drug in the US with a digital ingestion tracking system. 3 Similar digitalization of medical treatments and patient-related information is occurring in many other areas of healthcare and clinical research. For example, real-time patient data from medical devices and wear- ables can be used in the context of clinical trials, adverse event reporting, monitoring of adherence or in emer- gency room settings where the device can pinpoint, with high precision, the time and other circumstances of the onset of a given medical emergency. Physicians and hospitals are switching to electronic health records and rely on cloud-stored information to track individ- ual patients or to make diagnoses. At an even higher level in the healthcare system, comprehensive databases of medical insurance claims contain a wealth of infor- mation about patients' insurance, financial details, enrollment data, demographics, diagnoses, procedures, hospitalizations and medications dispensed. Respiratory conditions are among those that have been recognized as standing to benefit from digital-health tools through improved patient care and healthcare uti- lization. 4 Indeed, many examples of new technologies are intended for use with inhalation therapies. Several types of connected inhalers are already on the market and many more are in development. 5 ese technolo- Abstract In an effort to improve patient adherence with inhalation therapies, many companies are developing mobile appli- cations, devices or add-ons that enable electronic interac- tions with the user, such as monitoring, reminders, train- ing and health alerts. ese technological innovations hold the promise of improved healthcare outcomes, but they bring with them a new host of regulatory and legal considerations. Companies face a challenge, therefore, of maximizing their data assets while minimizing their legal and regulatory risks against the backdrop of a com- plex web of laws and regulations around the world. is article provides an overview of this rapidly evolving land- scape as well as some guiding principles that can help companies in their digital-product development. Introduction Opportunities A recent survey indicates that 46 percent of American consumers are now considered active digital-health adopters, having used digital-health tools such as wear- able devices or telemedicine. 1 Almost every week, trade news outlets and even mainstream media publish reports of new "digital," "e-connected," "bluetooth" or "smart" medical devices, platforms or add-ons. Sen- sor-enabled and internet-connected products are hailed as game-changers because they may enable patients to engage more directly in their own healthcare, or at least health monitoring. ey can also provide researchers or physicians with real-time data and make it easier for them to both find and monitor those enrolled. For instance, Apple is now conducting a study with Stanford