Key Legal & Regulatory Trends in the Trillion-Dollar Healthcare Market for the New Year

If you think Obamacare is the most important story in regulation of healthcare, you’re missing these key trends that will shape the medicine of 2015 and beyond. Remember that technological progress is ever-accelerating and that today’s office physical may seem like ancient history tomorrow. Pay attention to these legal and regulatory trends to stay on the right side of the law in your next or ongoing healthcare venture.

1. Telemedicine, mobile health (digital health) & mobile medical apps, wearable & implantable health technology, and health-related nanotechnology: These forms of virtual medicine are moving healthcare from the doctor’s office to your wrist or brain. By mid-2015 you’ll be wearing your doctor on your sleeve. Expect a holograph or robot in coming years. Legal rules governing licensure of practitioners are morphing from state-based to more national standards, based on interstate compacts. Self-healthcare data will flood encounters between patients and caregivers.

2. Integrative medicine is expanding its reach: Physicians are realizing the benefits of preventative strategies for health based on complementary and alternative medical therapies, and collaboration with CAM practitioners such as chiropractors, acupuncturists, massage therapists, energy healers, and naturopathic physicians. As the Cartesian/Newtonian paradigm continues to break down, we’ll see increasing openness to therapies once thought on the fringe of medicine. Emerging standards in integrative medicine, functional medicine, anti-aging medicine, will continue to grow and shape theories of medical malpractice, informed consent practices, and clinical care.

3. Concierge medicine will be the flagship model for physicians who remain outside the Medicare / Medicaid payment system. Medical doctors, and other clinicians will prefer to put patients on membership wellness plans, rather than fight through the reimbursement system. More providers will choose to opt out of Medicare, in order to be able to offer a wide variety of services (that would otherwise be Medicare-covered) through private concierge plans. These concierge medicine offerings will be available to every patient, not simply the wealthy VIPs.

4. Robotic surgery will accelerate, as will 3D printing of durable medical equipment and other healthcare products. FDA medical device rules will continue to expand to reach new technologies, as they have for mobile medical apps.

5. Healthcare practitioners will shift from services to healthcare products in order to continue bringing in revenues. For examples, your neighborhood practitioner of acupuncture and traditional oriental medicine will open an herbal medicine and dietary supplement company to provide a line of herbal care products. Sophisticated knowledge of FDA law governing structure/function vs. disease claims will be necessary so that companies can make marketing claims that get traction with patients, yet keep enforcement risk low.

6. Management services organizations (MSOs) will provide a vehicle for entrepreneurs to create new hybrid arrangements between non-clinician businesspersons and medical doctors or other practitioners. These MSOs will continue to skillfully navigate fee-splitting and corporate practice of medicine issues.

As we’ve written in Future of Medicine is Just a Tap Away (Daily Journal 11/5/04): “With the advent of wearable health technology, medicine moves into a new phase: on in which everyday health and wellness are becoming even more powerfully integrated into our overall vision of care. The trend here is a gradual merger of self-generated information about fitness and personal wellness into medicine — with the concomitant recognition that health and healing occupy a spectrum: from diseases that require serious clinical care, to mind-body-spirit wholeness, whose pathways are often mysterious, and reserved to the individual’s habits and decisions.” Personalized healthcare is here, moving at medicine in both directions: both from approaches emerging out of integrative care, and because technology is driving a more “me”-based approach. Existing laws and regulations will be stretched to cover the new paradigm, even as lawmakers and regulators work (as in the example of FDA Mobile Medical App Guidance) to create new frameworks to fit emerging healthcare technologies into established legal frameworks.

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