• 2019 HEALinc Summit Program Focus/Discussion Themes

    Event Program 5-Action Categories

    Digital Health

    Ethics & Standards

    Methodology & Design

    Regenerative Health



    Cross-Disciplinary Consensus Report


    Feeling and Doing Better in Reality – Not Just Looking Better on Paper

    Each of us is a hologram of our data. We are living at a time in history where we have more information now about everything than we have ever had since the beginning of time. This includes ubiquitous information on all aspects of disease, health, behavior, genetic and epigenetics and more. Significantly, individual health and wellness are inextricably linked to the health of families, communities, countries, the oceans and the planet.

    How do we navigate our way through and make sense of the jungle of 24/7 information so that new paradigm medicines offer truly “whole-person” and “whole-system” solutions for improving personal health and well-being? At the same time, how do we protect individual data sovereignty and freedom?

    • Is the data/information trustworthy about health in general and personal health in particular? How do we test and evaluate the trustworthiness of the information we are using in the evaluation of therapeutic efficacy?
    • What is the role of blockchain in healthcare as it relates to regenerative medicine and personal health?
    • Do we have a scientific and social obligation to use the vast volume of information available to us?
    • Is there a way of accessing and authenticating information relevant to personal health without actually sharing it? 
    • How do we protect the sovereignty of individuals and their data?
    • How do we create systems that reward individuals for positive health behavior and sharing health information (genomic, behavioral, physiological, etc.)?
    • Is there – or can we create – a succinct set of markers/metrics of personal health and wellness that can be tracked as part of the outcome measures of stem cell, regenerative and personal wellness therapeutic interventions?

    We need to employ modern epigenetic and augmented intelligence approaches to make sense of the information about who we are and how we are made (our individual personal wellness systems), as well as to ensure that the information we employ is accurate, trustworthy, authentic and relevant, and that individual sovereignty is protected at all times. New paradigm stem cell, regenerative and personal wellness therapeutics cannot just be about accessing new medicines; it must also be about living better lives.


    Evidence-Based Ethics and the Ethics of Optimal Health

    The Randomized Controlled Clinical Trial (RCT) has limitations. This is true of all medicines evaluated in RCTs. Even when new paradigm stem cell, regenerative medicine and personal wellness therapies are evaluated in RCTs, the results may not be able to help determine whether a therapy will actually help an individual patient, whether it might harm them or whether the therapy will likely have no effect at all.

    The methodological limitations for evidence-based clinical evaluation have significant ethical implications for informed consent and patient choice. Furthermore, the ethics around clinical trials and human experimentation are based on a paradigm of sickness care.

    • What’s the truth about the limitations of the RCT – not just for stem cell and regenerative medicine, but for all therapeutic interventions?
    • What are the ethical principles of personal wellness and optimal health?
    • Does a person have the right to optimize or even enhance their health? 
    • What is patient choice and free choice without accurate information? 
    • What are patients’ rights in data sovereignty? 
    • What is the meaning of informed consent when it comes to new paradigm therapies in the stem cell, regenerative medicine and personal wellness space? 

    We need new approaches to thinking about the ethics of therapeutic evaluation when it comes to new paradigm medicines. Methodology and design of therapeutic evaluations have ethical implications, as does the sovereignty of patient data.


    Clinical Studies Design for New Paradigm Therapies

    People are traveling to get the new paradigm medicines they hear about through word-of-mouth, the media, the internet or healthcare professionals. They believe these therapies will improve and/or optimize their health and well-being. This trend is not set to reverse and shows every sign of increasing.


    What are the challenges of patients buying access to clinical experimentation on their own bodies offshore?

    • Why are patients traveling to offshore destinations for new paradigm therapies they are not able to receive in the U.S. or their home countries? Are these stem cell, regenerative medicine and personal wellness therapies safe and efficacious? What is the science? 
    • How can we build on and improve the fast track ethical model created in The Bahamas for evaluating stem cell, regenerative medicine and personal wellness therapeutics? How can we replicate this prototype and open new “fast track” test beds in other countries and jurisdictions elsewhere in the world? 
    • How can The Bahamas partner with the FDA, NICE and other traditional regulatory systems elsewhere in the world to ensure that data obtained in The Bahamas and other “fast track” test beds can be repatriated to the U.S., Europe, etc. so that patients can access new paradigm therapies everywhere?  
    • Can the technological advantages of real-world data capture via fit-bits, sensors and other wearables that allow us to track therapeutic impact and outcome, and close the gap between the “unknowns” of new paradigm therapies? 
    • Is it time to make the fastidious pre and post-treatment follow-up that takes advantage of modern technology an essential component of the new paradigm therapy trial design?

      We need to create new models for evaluating the safety and efficacy that allow researchers/physicians to collect data to the best of their ability on new paradigm medicines and modalities in the stem cell, regenerative medicine and personal wellness space. This data allows us to determine the efficacy of these therapies based on the best, most trustworthy and accurate available knowledge/evidence. 

    Personal Wellness: Increasing Your “Playable Life”

    As people are living increasingly longer, they are also wanting to live better, healthier, more vibrant lives. Wherever possible, they also want to avoid medications that have toxic side effects or drain them of their energy and vitality. As evidenced by the four trillion-dollar valuation of the personal health and wellness industry, people from all walks of life (not just high-performance professional athletes) are using stem cell therapy, regenerative medicine and personal wellness modalities to increase their “playable life.”

    The emergence of a new paradigm threatens and often heralds the death of the old. What happens to the structure of the entire traditional medical ecosystem and the traditional way of “doing business” in medicine when true health – regenerative health, not the absence of disease – becomes the standard?

    • Does the stem cell regenerative medicine and personal wellness community have a social responsibility to create bridges to the future? 
    • If “stem cells” is the avatar of the new health paradigm, what are the laws and rules of the “new health” universe? What are the implications for communities and the planet?
    • What is the strategy for educating and engaging with traditional medicine frameworks and creating bridges to the new paradigm?

    Connecting the dots between the “whole-person” health paradigm of personal wellness and a healthier future for individuals, communities and the planet is a critical aspect of the regenerative health paradigm. This paradigm has biological, physiological, philosophical, social, cultural and economic implications beyond particular individual stem cell, regenerative medicine and personal wellness treatment modalities. Bridging to the future does not happen by accident.



    How Do We Pay for the Future Health Therapeutic Modalities? ​​

    Most patients pay out-of-pocket for stem cell, regenerative medicine and other new paradigm personal wellness therapies. This often places a significant burden on many patients who might benefit from such interventions and creates inequities in access to such medicines.

    • How can we create innovative approaches to reimbursement and support innovative approaches currently in progress?
    • Might there be more regenerative business models where patients receive rewards and price reductions for sharing (or allowing access to their health data)?

    ​​We must create more innovative ways of paying for and funding R&D of regenerative medicine, stem cell therapies and personal wellness modalities. The advancement of new paradigm medicines and approaches to health depends on it.