P4 Healthcare Means Medical Devices Increasingly Important in Healthcare Regulation

P4 medicine takes healthcare to a whole level, requiring deeper understanding of how healthcare & FDA law shape the path to market for your healthcare service or product. P4 medicine

Image: Institute for Systems Biology

I think of 20th and early 21st century medicine–the medicine I grew up with, in all its technological sophistication for the times–as service-oriented medicine. We still looked to doctors as descending from Mount Olympus with the technological P4 medicinemedical marvel to cure us. Future medicine I think of as product-oriented medicine. Think “Honey, I Shrunk the Kids,” only make it, “Honey I Shrunk the Doctor.” (He or she now fits on a little screen on my wrist or on my belt or futuristic retro-fashion suspenders).

The last few years we’ve been preoccupied with Obamacare which is really about employer obligations and insurance, not healthcare law. The next few years we’ll worry less about Medicare says and how it impacts physicians, and more about how telemedicine, mobile health, wearable health tech, lifestyle and fitness, mobile medical app, and medical device manufacturers and distributors are crafting health care and general wellness products that direct our health.

We’ll move more from sickness care to prevention and wellness care. Integrative medicine will continue to ascend, as will functional medicine, and other approaches to medical care that adopt a more holistic, whole systems orientation to personal health. And we’ll be integrating quantum self health data that we get from our fitness and wellness tracking devices.

Healthcare licensing laws, which govern practitioners, have consumed much attention with the advance of non-licensed practitioners. Given that practices are moving into technological, personalized / wearable domains, FDA regulation of cosmetics, dietary supplements and medical devices will be the legal and regulatory doorway to an evolving health and wellness marketplace.

Which brings us to P4, a technological approach that integrates holism, and picks up the rallying cry of integrative medicine for individualized, personalized healthcare that is preventative in nature.

The P4 in P4 Medicine stands for:

  • Predictive
  • Preventive
  • Personalized
  • Participatory

The P4 Medicine Institute states:

“The convergence of systems biology, the digital revolution and consumer-driven healthcare is transforming medicine from its current reactive mode, which is focused on treating disease, to a P4 Medicine mode…

P4 Medicine will improve the quality of care delivered to patients through better diagnoses and targeted therapies. These advances facilitate new forms of active participation by patients and consumers in the collection of personal health data that will accelerate discovery science. Soon a virtual data cloud of billions of health-relevant data points will surround each individual. Through P4 Medicine, we will be able to reduce this complex data to simple hypotheses about how to optimize wellness and minimize disease for each individual.”

The Institute for Systems Biology says P4 medicine will change the way healthcare is practiced, because it will predict illness by analyzing big data sets and personalized genomic information, deploying the information through business and social networks.

Spearheaded by Leory Hood, MD, PhD, this “systems” approach to disease brings together a cross-disciplinary approach that includes genomics, proteomics, informatics, nanotechnology and other sciences, and computational and mathematical tools,to create a “proactive,” wellness approach that will detect disease long before it manifests. According to Dr. Hood, evidence-based medicine is reactive, disease-centric, and tested against large populations; whereas P4 medicine is proactive, focuses on wellness maintenance, takes many measurements in an individual-centric way, and stratifies disease populations into relatively small groups (to garner faster FDA drug approval).

In Systems Biology and P4 Medicine: Past, Present, and Future, Hood predicts:

P4 medicine will cause every single sector of the health care community to rewrite their business plans, and many will be unable to do so due to their conservative business outlook. P4 medicine will create enormous wealth for those who adopt it. In 10–15 years, the wellness industry will far exceed the disease industry, also known as the health care industry. In addition, the wellness industry will probably be developed by companies that are completely different from those currently engaged in health care. P4 medicine will be able to reduce sharply the escalating costs of health care to the point where we will be able to export it to the developing world, leading to a democratization of health care, a concept unimaginable five years ago.

Hood also speaks to the revolutionary social implications of P4 medicine. These have to do with evolving medical care to meet technologies that can provide highly predictive approaches to disease that are also intensely individualized (personalized).

I think the P4 medicine revolution has two enormous societal consequences. It will absolutely transform the business plans of every sector of health care. Which will adapt and which will become dinosaurs? That’s an interesting question, but it will mean enormous opportunities for companies.

I also think it will lead to digitization of medicine, the ability to get relevant data on a patient from a single molecule, a single cell. I think this digitization in the long run will have exactly the same consequences it has had for the digitization of information technology. In time, the costs of health care will drop to the point where we can export it to the developing world. That concept, which was utterly inconceivable a few years ago, is an exciting one.

We will all have a personal “dashboard” of health which will analyze where we are with respect to our individual genomic sequence. Among other things, our indicators will be cardio activity, sleep patterns, proteins, cholesterol, blood metabolites, and epigenetic profile (chemical reactions that switch crucial genes on and off).

This year:

President Obama asked Congress to approve spending in medical research that tailors treatment to individual genes–for a precision medicine initiative that moves away from one-size-fits-all treatments to individualized genetic care.

Concierge medical practices will avail themselves of these trends. And healthcare regulators will take note, just as they have developed telemedicine laws so as not to lag too far behind marketplace telemedicine developments.

And just as soon as P4 takes off, we’ll have the next iteration of healthcare products – perhaps fashioned by successive generations of robotic minds that already know how to compose poetry and cook. Whether the legislative and legal frameworks that govern healthcare can adapt quickly enough remains to be seen. More than likely disruptive medical technologies will continue not only to wreak havoc on corporate behemoths that are not sufficiently lithe to adapt, but also disrupt legal and social frameworks as well.

Our medical device and FDA attorneys and healthcare lawyers track developments so we can counsel our clients on their healthcare and FDA compliance legal obligations. Contact our health care and FDA legal team for laws and updates relevant to your situation.

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