Implementation of P4 medicine relies on achieving two major objectives. First, the technical aspects of systems medicine - strategies, technologies, analytical tools -must be developed so that big data can be generated and analyzed to reveal the dynamic networks for each patient. The technical solutions to these challenges are advancing very effectively. Second, the societal challenges of P4 medicine must be solved - and in our mind these represent far greater hurdles for the acceptance of P4 medicine into healthcare systems [11
]. These societal challenges come in eight forms, as follows.
First, there are the obvious questions that relate to the ethical, legal, societal, security, privacy, policy, regulatory aspects and economics of P4 medicine that deal with individual patients. These have been discussed extensively elsewhere [12
Second, there is the fascinating and difficult question of who is included in the term 'participatory’. Obviously patients must be included because a core idea of personalized medicine is that patients increasingly take control of their own health. However, to integrate P4 medicine into healthcare systems, we must also include physicians and other healthcare workers, other members of the healthcare system (payers, providers), those concerned with policy and implementation of healthcare, and those involved with education of students and the general public. Bringing all these participants into alignment around P4 medicine is an enormous challenge.
Third, ultimately bringing these participants into alignment will necessitate a change in education and consumer feedback - how do we bring an appropriate understanding of P4 medicine to all participants in the healthcare system? And how do we systematically obtain their feedback for guidance in developing new wellness products and services? Our feeling is that these enormous challenges can only be solved by employing powerful IT tools, such as the massive online open courses that are transforming the practice of higher education, bringing it within reach of much larger numbers of individuals [13
]. Indeed, we submit that the IT for healthcare of the future should include the means for educating all participants.
Fourth, it is essential to educate patients regarding the value of their data and how it can advance biomedical science without injury to them. A key to the continuous improvement of P4 medicine is the ongoing mining of the personal data clouds of billions of individuals. For this will allow rapid progress in our understanding of the complexities of disease and wellness - and profoundly change healthcare. Hence after appropriate de-identification, it is essential that each patient’s data cloud be available for mining for the predictive medicine of the future. The narrow and restrictive institutional ethical review board policies of today must be replaced with open access to data for qualified professionals - with appropriate protection for the individual.
Fifth, patient (consumer)-activated social networks will play several important roles in assuring that patients will be empowered to participate actively in P4 medicine. Several such networks are already changing medicine, and one example is the ’quantified self' networks that have now spread widely in the United States. Individuals in these networks use digital devices to measure their own physical parameters (weight, pulse, respiration, quality of sleep, stress, and so on) and use them to optimize health [14
]. There are also many disease-oriented social networks (for example, PatientsLikeMe, Breast Cancer Alliance, Multiple Myeloma Research Foundation) that are already beginning to alter how clinical trials are carried out [5
]. These social networks illustrate that healthcare and wellness can move away from hospitals and into foundations and even the home. This decentralization of medicine is an important aspect of the emerging P4 medicine focus on wellness.
Sixth, our view is that patient-activated social networks will be one of the most powerful forces in driving the acceptance of P4 medicine. Already patients are beginning to question whether they want to have physicians who do not know anything about their genomes, or nutrition or wellness. Patients are beginning to move to more recently trained physicians knowledgeable of the new technologies and strategies that are transforming the practice of medicine. A challenging question is how to generate the patient-activated social networks that will trigger the healthcare systems to accept P4 medicine.
Seventh, it is clear that the participatory aspect of P4 medicine is extremely dependent upon first class IT for healthcare capable of managing and integrating millions to billions of personal data clouds - that is aggregating, mining, integrating them and finally producing models for each patient that are predictive and actionable - thus defining the future architecture of P4 medicine. In addition, it is essential that there be a 'trusted third party site’ that contains up-to-date and accurate information on systems medicine and P4 medicine. Too often patients come to their physicians with incorrect information that has been obtained from the Internet. There needs to be an accurate and trusted source of information - for patients, physicians and healthcare workers.
Eighth, it is clear that if the information from patient data clouds is to be used effectively to optimize their wellness and minimize disease, there needs to be a trusted interpreter of these data clouds for each patient. It is our view that a new healthcare professional, which we term a healthcare and wellness coach, will need to be created who can look at the patient’s data cloud and present it to them in a way that encourages them to use their data to improve their health. We believe that nursing and general medical practice would be an ideal starting background from which to train such individuals.