Progressing the health agenda: responsibly innovating in health technology^*

* Adapted from keynote address at the OECD’s workshop on ‘Neurotechnology and Society: Strengthening Responsible Innovation in Brain Science,’ September 16, 2016, Washington DC.

ABSTRACT

The World Economic Forum (WEF) contends that the world is at the cusp of a Fourth Industrial Revolution. Predicated upon past advancements, this Revolution will usher in new technologies that are personal, predictive, and increasingly preventive. Several of the technological innovations emerging in the Fourth Industrial Revolution are in their infancy. This means that the innovation landscape can be designed to suit the needs of humanity. Shaping this landscape will require proactive actions by a variety of stakeholders to address the ethical, legal, and social implications of new technologies in health, including neuro-technologies. This perspective article is an adapted keynote address from the OECD’s workshop on Neuro-technology and Society, which aimed to examine the science and society interplay in brain research, and the development of novel neuro-technologies.

KEYWORDS:

• Guidelines
• neuro-technologies
• personalized health technologies
• wearables
• ethical
• legal
• social implications

1. Introduction

Every year, the world’s most influential leaders gather in the quaint, wintery town of Davos, Switzerland to discuss the most pressing issues facing humanity. The 2016 World Economic Forum (WEF) centered on the Fourth Industrial Revolution. Klaus Schwab, the Founder and Executive Chairman of the WEF, contends that the world is at the cusp of a Fourth Industrial Revolution (Schwab 2016). The First Industrial Revolution, which spanned from 1760 to 1840, provided mechanical production, with the construction of railroads and the creation of the steam engine. The Second Industrial Revolution, which began at the turn of the twentieth century, brought mass production through the advent of electricity and the assembly line. The Third Industrial Revolution, commencing in the 1960s, saw the invention of computers, semiconductors, and the Internet. Today, the Fourth Industrial Revolution is characterized by smaller, more powerful, and cheaper sensors; cognitive computing advancements in artificial intelligence, robotics, predictive analytics, and machine learning; the Internet of Things; additive manufacturing/3D printing; nanotechnologies; neurotechnology; biotechnology; and much more.

Several of the technological innovations emerging in the Fourth Industrial Revolution are in their infancy. They are being developed in cutting-edge research facilities, spanning institutions and national borders. Others are being tested on our streets or in or on our bodies. The uncertainty around the creation and adoption of these new technologies means we do not know, or we are unsure, of how the Fourth Industrial Revolution will unfold. Will these new technologies wipe out jobs to create technological unemployment? Will they eradicate death in all forms? How will they impact the well-functioning of our planet?

If we are at the cusp of the Fourth Industrial Revolution, we have an opportunity to shape the innovation landscape – including the brain sciences landscape – of today. We can be proactive and not reactive. We can be thoughtful and deliberate, and not rash or irrational. We can develop innovations that generate as much benefit for society as for the entities that create them. This type of meticulous and thoughtful innovation requires a different mindset, a collaborative one. It requires the cooperation of disparate stakeholders, ranging from government and business to academia, non-profit, and civil society.

The workshop on Neurotechnology and Society – convened by the Organisation for Economic Co-operation and Development (OECD) – was an initial gathering to uncover ideas and approaches, and promote coordinated efforts, underlying the science and society interplay in brain research and novel neuro-technologies. Overcoming the challenges posed by new neuro-technologies will require addressing related ethical, legal, and social concerns.

2. Ethical, legal, and social implications of health technologies

As with any new technology, thorny ethical, legal, and social concerns arise that could impact uptake by all populations. From an ethical perspective, challenging questions arise: To what extent do we rely on technological algorithms or human judgment when making decisions? What safeguards are necessary to ensure adequate confidence among the public? How do we balance benefits and risks? From a legal perspective: To what extent do varying consent models impact engagement with new technologies? How does the language used to communicate privacy protocols affect the acceptance and adoption of the technology? Finally, from a social or cultural perspective: How do we design innovations that target widening health disparities? How should governance models incorporate disparate stakeholder voices? These are a sampling of the complex ethical, legal, and social questions that arise when engaging in the innovation process.

Similar issues emerge when exploring brain sciences and neuro-technologies. One controversial but concrete example is brain training. Brain training captured headlines when federal regulators fined the well-known brain training app, Lumosity, for delivering lofty marketing claims (Federal Trade Commission 2016). Following a closer examination, the evidence underlying the app remained insufficient. While the National Academies of Sciences, Engineering, and Medicine presented the evidence underlying the effectiveness of brain training and concluded that people (particularly older adults) can benefit, no significant transfer effects were demonstrated between trained and untrained cognitive processes (Blazer, Yaffe, and Liverman 2015). It should not be taken for granted that the public will accept other, more invasive, technologies that target the brain. The broad acceptance of technologies for the brain will require careful planning and dedicated resources.

Some may ask the question: Have there been initiatives that have been successful or unsuccessful because of their consideration – or lack of consideration – of ethical, legal, and social concerns? Several would contend that the Human Genome Project has led to substantial gains in understanding genetics and genomics (National Human Genome Research institute 2015). Ethical, legal, and social considerations were examined at the outset and continued throughout the program (Collins 1999; Collins, Morgan, and Patrinos 2003). Today, there are consumer tests that provide ancestry information based on a saliva swab in addition to a newly federally funded Precision Medicine Initiative to advance the Human Genome Project (Precision Medicine Initiative Cohort Program 2016). Is the public more comfortable with genetic testing having explored ethical, legal, and social implications early on in the initiative? Probably. Genetically modified foods (GMOs) are one example where the scientific community has been less effective at addressing these concerns. In many countries, GMOs are shied away from because of the belief that they are unnatural or will cause other problems (Gaskell et al. 2000). This is despite the fact that GMOs have potential to help minimize global hunger (see, for example, Pinstrup-Andersen and Schiøler 2003).

Personalized health technology – wearables, smartwatches, and mobile health apps – is an emerging area of innovation that is budding with creativity, but that also has potential for harm if ethical, legal, and social challenges are not proactively overcome. The rapid proliferation of personalized health technologies in the marketplace has led to concerns with health and fitness data. Unlike medical information, which in the United States is protected by federal regulations such as the Health Insurance Portability and Accountability Act (HIPAA), regulations for data from personalized health technologies have remained one step behind (Future for Privacy Forum 2016). If the data are mishandled or if the public fails to accept these technologies for other reasons, the benefits to health for individuals and society may not be realized.

Given Vitality’s¹ partnerships with developers of personalized health technologies to deliver its shared value insurance model and workplace health promotion program, the company aspired to demonstrate its leadership in addressing the associated ethical, legal, and social concerns. Vitality initially partnered with Microsoft and the Qualcomm Institute at the University of California, San Diego to consider best practices in responsibly innovating these technologies in addition to the stewardship of health data. We first launched a global public web-based consultation to identify best practices in response to two questions: (1) How do we responsibly innovate personalized health technologies? And (2) How do we be appropriate stewards of data from these devices?

Vitality received constructive feedback from a variety of stakeholders – academic researchers, business leaders, government representatives, journalists, and consumers – all operating across sectors and geographic locations. The feedback focused on the need for public and private partnerships to advance personalized health technologies, academia at times being disconnected from the demands of consumers, and who the rightful owner should be of health data. Following the three-month public consultation, Vitality and its partners released a finalized set of guidelines in March 2016 (Christie, Patrick, and Yach 2016).

3. The five guidelines for health technology

The first guideline was that personalized health technologies must be informed by science. They must be designed using the latest science and data. They must be evidence-based and recommend appropriate health activities. As an example, should personalized health technologies recommend 10,000 steps per day, 5000 steps per day, more than that, or less than that? The 10,000 number that a majority of fitness trackers use as the default is embedded within the scientific literature as the target number for seeing improvements in health (Choi, Pak, and Choi 2007). Despite the benefits to health, organizations designing personalized health technologies often unsystematically – or entirely neglect to – integrate scientific evidence into their devices. A majority also do not test the impact of their interventions on improving health. These considerations ultimately serve to promote a transparent marketplace for consumers, companies, and clinicians.

The second guideline was to scale affordable personalized health technologies. Current incentives to create innovative technologies often lead companies to recoup their initial investments in research and development through high prices for early adopters. A majority of new personalized health technologies entering the market are priced so that they are only affordable to select few who are often already healthy and wealthy. This does not benefit individuals with lower incomes who often have poorer health than their wealthy counterparts.

The third guideline was to guide the interpretation of health data. Poor health literacy and numeracy contribute to poor health. If users are unable to initiate changes in their behaviors based on data that are delivered to them, the potential for them to demonstrate improvements in health will decline. Currently, a mismatch exists between those consuming health information and those designing the technologies that deliver this information. Ensuring that the data from these technologies is easily and visibly understood will go far to ensure their continued use over time. Customizing the experience of personalized health technologies to a user’s level of health literacy can also improve engagement in addition to accounting for cultural and linguistic preferences.

The fourth guideline was to protect and secure health data. An information asymmetry between companies and consumers is developing. Any corporate handling of health data that are misaligned with user expectations quickly discourages trust. Improvements to health through personalized health technologies are unlikely to be realized without rigorous data privacy and security practices. Organizations must be transparent in how they protect and secure data. They must have easily understandable privacy consents, and they must design their products with privacy and security features throughout the entire development process as opposed to an added feature at the end. We advocate for the use of privacy-by-design and security-by-design, by which strong privacy and security features are integrated into the design of the technology at the outset.

Finally, the fifth guideline was to govern the responsible use of health technology and data. By this, organizations must disclose their practices on how they create health technologies and handle data through corporate or annual reports. Consumers should be able to access information on how companies address these ethical, legal, and social challenges. Bringing greater transparency and governance in this area will be necessary in ensuring the broad uptake and use of personalized health technologies.

4. Responsibly innovating health technology for the future

As in brain sciences, we must generate solid and substantial evidence, we must scale affordable health technologies, we must facilitate the interpretation of results, we must protect and secure data, and we must ensure strong governance and accountability. The lessons are no different for personalized health technologies than they are for neuro-technologies or for artificial intelligence, embeddable sensors, robotics, or any other technology within the Fourth Industrial Revolution.

Our initial notion was to determine how we could work with partners to create a self-regulatory framework for the personalized health technology industry. Many questioned the extent to which companies would be amenable to the guidelines. Overall, companies were receptive, believing that they were contributing to conversations that would help change the dialogue around health technology. Our next step is to consider how the guidelines may be applied to rapidly emerging mental health promoting and human enhancement technologies, with particular applicability to older adults.

There will always be a balance between fostering innovation and the government’s ability to introduce regulations that ensure protection. In new areas characterized by the Fourth Industrial Revolution, we need to determine how corporate players can work in partnership to act responsibly for the greater good. We should not stigmatize the private sector, but in fact work with them, as many of their goals are in fact aligned with other, non-corporate stakeholders. The WEF’s recently announced Center for the Fourth Industrial Revolution may serve as one venue to convene businesses and other stakeholders to advance the global conversation on science and technology governance.

Today, we have an opportunity to usher in transformative innovations that will benefit all populations across all age spectrums. We can work together toward this common goal, or we can work in silos and competitively against each other. It is also our responsibility to ensure that we establish common values that drive effective policy changes that affect all. Governments will need to work with business, non-profits, civil society, and others to ensure broad transformations.

Responsible innovation is a decision. It is a decision about the way to innovate, the way to create new products, services, structures, and processes. It is a choice between today and tomorrow. As explorations of the ethical, legal, and social concerns associated with brain sciences and neuro-technologies are progressed, remember that change is a decision that comes from within – it is entirely our making in how we create the future.

Disclosure statement

No potential conflict of interest was reported by the author.

Notes on contributor

Gillian Christie is a Health Innovation Manager at Vitality. She is a leader in personalized technologies that promote health and prevent disease, and explores their related ethical, legal, and social implications. Gillian previously worked at Grand Challenges Canada, where she researched investment areas within non-communicable diseases. At the Sandra Rotman Centre, she assessed health technologies for application in developing countries. Gillian was also a Director of SimPrints, a health technology start-up focused on patient identification using mobile biometrics. Gillian has spoken at a variety of events, including the World Economic Forum, the Consumer Electronics Show (CES), and the Harvard T.H. Chan School of Public Health. She is a Fellow of the Salzburg Global Seminar and a contributing author to the Lancet and Rockefeller Foundation’s Commission on Planetary Health (July 2015). Gillian completed a Master’s (M. Phil.) degree at the University of Cambridge in Innovation, Strategy and Organization, and holds a MA (Hons) in Management from the University of St Andrews in Scotland. She is a paid employee of Vitality Group, part of Discovery Ltd.

Notes

* Adapted from keynote address at the OECD’s workshop on ‘Neurotechnology and Society: Strengthening Responsible Innovation in Brain Science,’ September 16, 2016, Washington DC.

1 Founded by the South African insurer, Discovery Ltd., Vitality is an incentive-based health promotion program offered globally.