How laws governing wearable health technology shape our medical future
|Michael H Cohenfirstname.lastname@example.org|
Wearable health technology makes medicine a triangular collaboration between physicians, patients, and machines. This triangle changes the business and clinical practice of healthcare by moving medicine out of the doctor’s office, into an omnipresent, virtual stage where health and wellness care is available anywhere and everywhere, 24/7, through multiple and diverse channels, with the consumer/patient holding the remote.
This workshop focuses on what business (and clinicians) must do to adapt to the changes in our medical future that wearable health technology brings. Specifically, we will discuss 4 key trends:
1. Telemedicine: Patients will no longer “visit doctors,” but will understand that they are “wearing their doctor on their sleeves.” Physicians will be seen as disease care experts, but patients will be self-reliant for prevention, wellness, and fitness. By integrating quantifiable self-data into medical decision-making, patients will claim more responsibility for their own health; they will focus on preventative self-care and lifestyle changes; and they will view physicians as experts who may only rarely be required—i.e., for treatment of advanced conditions when self-care fails. Understanding the telemedicine legal landscape will be crucial to meet this changing marketplace.
2. Mobile care: Medicine will be driven by consumerization and appification. Consumerization—the movement from organization-driven offerings to consumer-driven priorities (such as, in healthcare, yoga, herbal medicine, and alternative therapies) will not only make patient-centered care the dominant paradigm, but also will increase the market share for complementary and integrative medical approaches. Appification—the reduction of in-person, clinical care to online or mobile visits—will further reduce the intimacy of physical relationship between doctor and patient, and additionally drive exploration of pluralistic approaches to care. Obamacare, along with diminishing Medicare and private pay reimbursement, will drive physicians to develop health care products (from dietary supplements to medical devices and mobile medical apps) as a way to garner patient revenue. Overall, healthcare will move from the service to the product sector. Understanding key FDA rules will be critical.
3. Corporate ownership of medical information: Privacy and security questions will continue to haunt both medical service providers and creators of medical data storage products. HIPAA remains the regulatory behemoth that overshadows exchange of medical information; government increasingly intervenes with enforcement actions that showcase the vulnerability of even small medical practices and start-ups. Given that data breaches are inevitable, practitioners and business owners will have to make business judgments regarding compliance efforts. Further, as patients increasingly turn their medical data (and medical care) over to “Dr. Google,” their smartphones, and other electronic storage and feedback systems, battles will continue to arise as to who owns or can sell patient data. Intellectual property issues will predominate.
4. Ubiquitous healthcare. The highly politicalized era of government-driven healthcare reform will seem anachronistic and archaic, as physicians increasingly bypass insurance reimbursement mechanisms—and from the patient side, access to healthcare becomes ubiquitous via online, mobile, and wearable networks. Given that FDA recently has indicated that it will take a ‘hands-off’ posture with respect to “low-risk general wellness products,” the healthcare market will be ever more open to technological innovation. Medical practice is morphing from physical to mobile, wearable, and ultimately, implantable. From state regulation of practitioners through licensure, to federal regulation of deceptive advertising, businesses and practices will need to understand how the regulatory landscape shapes not only what they can do, but what they say they can do.
As a result of these trends—telemedicine, mobile care, corporate ownership of medical information, and ubiquitous healthcare—medicine will no longer remain contained within the doctor's office, but will be everywhere and anywhere. Health and wellness may also be our dominant human preoccupation as we all live longer, feel healthier, and look better.
Current marketplace trends as well as legal rules shape our emergence as self-aware beings that bridge technology and consciousness. That is why, beyond identifying marketplace drivers, we examine key legal rules that underpin the healthcare marketplace; and review how business and practices can optimally respond. Only those who understand the changing landscape can make it to market, or stay competitive in navigating the trillion-dollar health and wellness landscape. We are redrawing the map of what it means to be human, wearing on health data on our sleeves, and merging mind-body awareness with the quantifiable self.