Data linkage and sharing for healthy longevity together present a global challenge, in the view of Prof Makoto Suematsu, Japan Agency for Medical Research and Development and Rihana Diabo at the World Economic Forum
Data sharing in medicine is easier said than done. Of particular importance is data sharing across national borders. The evolution of deep space science resulted from global data sharing that helps researchers discover black holes using hundreds of radio-telescopes set up all over the world. In medicine, on a positive note, infectious disease research initiatives including Global Research Collaboration for Infectious Disease Preparedness (GLOPID-R) and Infectious Disease Data Observatory (IDDO) are advocating for global data sharing to improve diagnosis and treatment of patients and to ensure coordinated and effective responses to emerging infections and cross-border threats to health. (1) The International Rare Diseases Research Consortium (IRDiRC) found that nearly 80% of rare disease researchers who responded to its survey had experience of sharing data internationally.
Why are successful examples so rare in medicine? Reasons include intra- and extra-territorial factors; coordination failure among different ministries responsible for health care and medicine under heavy bureaucracy, siloed systems of electronic health records within individual nations, conflicts and competition for medical research resources among individual researchers and industrial sectors all over the world, etc. In these circumstances, how can we utilise global data sharing to fast-track medical R&D and achieve healthy longevity all over the world?
Super-ageing is one of the biggest issues for global health which, sooner or later, most of countries will experience. As predicted previously (2), the competition for resources dictated by free-market principles will be the undoing of the medical commons. Sooner or later, most of countries will need to adopt global mechanisms to foster innovative ideas raised by young investigators and to catalyse them within the private sectors and to share challenging experiences between preceding super-ageing nations and younger nations. We cannot otherwise guarantee sustainability.
An area of global importance is the ageing of the population. It is predicted that by 2050, 1.6 billion or 18% of the world’s population will be over 60 years old. This is associated with a global decrease in fertility rates. In Japan, around the time of the Meiji Restoration (1868), only 20% of Japan’s population was over 50 years old and that percentage remained more or less unchanged until the 1970s. The Japanese population started to age rapidly around then, however, introducing universal health coverage, the eradication of major infectious diseases and rapid economic growth had the combined effect of increasing life expectancy and reducing fertility rates inexorably.
Japan has, thus, now become a super-aged society and the trend is continuing: By the 2040s, an unprecedented ultra-super-ageing demographic drift will reach its peak with only 35% of the population being under 50 according to the prediction by Dr Toshihiko Hasegawa). In 2019, now that this great population shift has already advanced two-thirds of the way through this great transition phase, Japan has only two decades in which to find effective solutions to ensure healthy longevity by the time it reaches the ageing peak.
It should be noted that developing the drugs and medical devices needed for any such solutions takes time. If we consider the likelihood that many other countries will also begin to age rapidly in the next few decades, global sharing of data and values on comprehensive medical/environmental/social studies for healthy longevity are indispensable to achieving sustainability of human health. A good practice to follow in the global sharing of data would be the Alzheimer’s Disease Neuroimaging Initiative (ADNI) project (3), which has strict rules designed to encourage sharing of collected data among its members including both public and private research institutions.
The super-ageing of populations might serve as a huge opportunity to promote a so-called silver market for human wellness. At the meeting of the Global Future Council (GFC) on Human Enhancement and Longevity held in Dubai during November 2018, the Council organised the four workstreams for healthy longevity researches: “Understanding needs of the elderly to fully leverage the opportunities of the silver market”, “Ethics, equity and governance of an ageing world population”, “Appreciating the human capital of older adults and developing human capital for the care of older adults” and “Global data sharing”.
Countries offering public funding to R&D projects on healthy longevity should make it a condition that the resulting data be shared internationally after an appropriate waiting period. Such discussion was further galvanised at the Davos-Kloster meeting in January 2019, as exemplified by Prime Minister Abe’s speech proposing “Data Free-Flow with Trust” for medical and industrial R&D purposes, while the privacy of the individuals’ health data should be sufficiently secured.
Data linkage and sharing among different health care stakeholders may provide numerous benefits for healthy longevity. The decline in the physical functions of the elderly patients is not steady but staggered and is typically precipitated by hospitalisation for acute diseases. Accumulating clinical data on ageing patients with acute illness can facilitate more detailed monitoring of this trend and help to optimise medical care services. Nursing care for the elderly is another area that could benefit from data sharing.
One promising approach in this regard is human enhancement using biomedical technologies to augment the physical/mental capabilities and health of those that are weakened with age. Some human enhancement technologies have widely been adopted, including interocular cataract lens (IOL) implants, bipolar hip arthroplasty (BHA) for osteoarthritis and pacemaker implantation for heart failure patients.
The development of more ambitious enhancement technologies will require the comprehensive use of new materials, robotics, artificial intelligence (AI) and nanotechnology and among others, together with the continued collection and analysis of clinical data for fast-tracking next-generation silver R&D.
Unlike established medical procedures to treat diseases and restore mental and physical functions which are approved following clinical trials with middle-aged participants, further application of human enhancement technologies for the overall improvement of health and well-being for the elderly will require careful consideration of many issues. Human enhancement technologies that are physically and/or psychologically invasive must be demonstrably safe to use for the elderly, just like any medical procedures. Invasive human enhancement technologies are ultimately a means to complement the users’ physical and/or mental functions and to improve their health.
A survey by the American Association of Retired Persons (AARP) on the application of human enhancement technologies revealed that of approximately 2,000 adult respondents, over 90% supported the use of the technologies to regain normal physical and mental functions, including sight recovery and joint replacement. However, the respondents did not approve of applying the technologies to acquire exceptional or superhuman abilities, such as sharper cognition (memory) or increased muscular strength. (4) As this survey demonstrates, there is a public awareness that human enhancement technologies have the potential to allow us to overstep our limitations, which could change the very foundation of society and humanity as we conventionally see them. Such adaptation and tolerance levels might differ among different countries with different cultural backgrounds.
Maximising the potential benefits of global data linkage and sharing will initially give rise to many difficult multi-factorial challenges: the first and the most important challenge is the fact that the European Union (EU) general data protection regulation (GDPR) has now extraterritorial impacts. GDPR holds data controllers accountable for multiple principles as follows; collection limitation, data quality, purpose specification and use limitation, security safeguards, openness and finally individual participation. When handling personal human data, we need novel information technology to achieve global data sharing in accordance with GDPR principles.
New approaches to consent management or dynamic consent (5,6) that allow individual participants to consent or not have been trialled in the UK and EU and by global organisations including Global Alliance for Genomics and Health (GA4GH), while their social implementation will require a bit more time. Second, it is necessary to build public funding frameworks and a consensus policy of “no share, no budget” among funding agencies around the world. (7) Integration of different databases/knowledge bases supported by public funding should be facilitated under such a policy. Researchers who benefit from public funding should waive their claims to priority access and willingly share a significant part of their unpublished research data for the benefit of patients and ultimately, the benefit of all people.
The third challenge is data linkage. Besides successful examples in Estonia, Finland and Denmark, countries with populations greater than 10 million experience difficulties in forming links among many domestic knowledgebases. Japan has a huge National Database (NDB) which aims to collect the whole-nation information on individual patients’ medical care and costs. Currently, tight regulation exists limiting the use of the data for academic and commercial purposes. NDB includes a huge amount of information on pharmaceuticals, medical devices and other medical treatments carried out by physicians in all hospitals and out-patient clinics in Japan as a function of lifetime until death.
In May 2019, under enactment of the new law, the Ministry of Health Labor and Welfare decided to connect the NDB and the Long-term Care Insurance database (LCIDB). For more than 20 years, LCIDB has accumulated full data on those who are more than 65 years old and require nursing support from the government. In the future, the link between NDB and LCIDB will lead to a better understanding of how a person’s history of medical interventions relates to their eventual medical outcomes or quality of life.
Such database linkage might give rise to concerns among the data subjects that research discovery may show linkage of multiple diseases and its misuse by insurance companies. However, the data linkage benefits strategic planning for healthy longevity by allowing analyses of activities of daily living (ADL) and patients and families’ burdens for nursing care and investigation of the linkage with past medical cares received by the individual elderly patients. Integral and quantitative analyses of the real-world data of medical and nursing care data will not only allow us to optimise the balance between medical and nursing costs but also to reveal unmet needs for nursing care that will galvanise nursing R&D.
The number of Alzheimer’s patients around the world has doubled in the past 26 years. (8) Deaths from Alzheimer’s disease increased 148% in the same period, making it the fifth leading cause of death. Since the supply of available medical resources is finite and increasingly constrained, we need to employ far more powerful mechanisms for data linkage and sharing in order to conquer Alzheimer’s disease. Recent multinational studies providing a robust staging system of Ab accumulation that may be useful for monitoring patients throughout the course of AD exemplified critical roles of ADNI database consisting of 18F-florbetapir PET imaging as well as availability of gene expression information from Allen Human Brain Atlas database. (9,10,11)
Another important aspect of global data sharing that is challenging yet needs to be explored is cooperation with the private sector—especially with private entities that are pursuing human enhancement to achieve healthy longevity. The experiences and values gained in present-day Japan must inform future design for other countries which will follow in its ageing footsteps.
Healthy longevity for all people is a grand challenge requiring activation and collaboration among young multidisciplinary researchers all over the world and this is reflected in the launch of the U.S. National Academy of Medicine’s Grand Challenge in Healthy Longevity. The establishment of a global data linkage and sharing for healthy longevity has the promise to bring major changes to the silver medical R&D. The GFC members hope that this message will prove to be the first step toward making such a scheme a reality for quality of healthy longevity.
References and notes
1. GDPR Art. 9. Processing of special categories of personal data 2 (i).
2. Hiatt HH. Protecting the medical commons: who is responsible? N Engl J Med. 1975 Jul 31;293(5):235-41.
3. Schmidt ME, Siemers E, Snyder PJ, Potter WZ, Cole P, Soares H.
The Alzheimer’s disease neuroimaging initiative: perspectives of the Industry Scientific Advisory Board. Alzheimers Dement. 2010 May;6(3):286-90.
4. Whitman D, Love J, Rainville G, and Skufca L. U.S. public opinion & interest on human enhancements technology: January 2018.
5. Spencer K, Sanders C, Whitley EA, Lund D, Kaye J, Dixon WG.
Patient perspectives on sharing anonymized personal health data using a digital system for dynamic consent and research feedback: A qualitative study.
J Med Internet Res. 2016 Apr 15;18(4):e66.
6. Williams H, Spencer K, Sanders C, Lund D, Whitley EA, Kaye J, Dixon WG.
Dynamic consent: a possible solution to improve patient confidence and trust in how electronic patient records are used in medical research.
JMIR Med Inform. 2015 Jan 13;3(1):e3.
7. Adachi T, Imanishi N, Ogawa Y, Furusawa Y, Izumida Y, Izumi Y, Suematsu M. Survey on patients with undiagnosed diseases in Japan: potential patient numbers benefiting from Japan’s initiative on rare and undiagnosed diseases (IRUD).
Orphanet J Rare Dis. 2018 Nov 20;13(1):208.
8. GBD 2016 Dementia Collaborators. Global, regional, and national burden of Alzheimer’s disease and other dementias, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016 Lancet Neurol 2019, 18, 88-106.
9. Mattsson N, Palmqvist S, Stomrud E, Vogel J, Hansson O. Staging b-amyloid pathology with amyloid positron emission tomography. JAMA Neurol. 2019, doi:10.1001/jamaneurol.2019.2214.
The authors thank Drs Toshihiko Hasegawa and Professors Tomoaki Imamura and Nanako Tamiya for providing priceless knowledge about healthy longevity. We also thank AMED staff members Drs Yoko Izumi, Yoshihiko Izumida and Makiko Kusama and Mr Hiroya Hirose, for sharing useful information and Mr Sean Fox and Mr Martin Gadsden in AMED for brushing up the manuscript.
• Makoto Suematsu (Co-chair)
• Victor J Dzau (Co-chair)
• Janneke Annegarn
• Linda P Fried
Global Future Council for Human Enhancement and longevity 2018-2019:
The list of members is available here.