In the healthcare sector alone, recent cases of these concerns have arisen in relation to genetic testing and precision medicine, genome-editing, transcranial direct current stimulation, mobile health (mHealth) and wearable technologies (currently under review, inter alia, in the US, UK and Australia), glucose optical tracking, and medical data storage and sharing technologies. Readers are likely familiar with the cases of 23andMe, who received authorisation by the US Food and Drug Administration to market its genetic tests for disease risk assessment to consumers in April 2017, and of the genome-editing technology CRISPR/Cas9, whose related patents are currently being litigated in the US (US Court of Appeals for the Federal Circuit, Appeal No. 2017-1907), for issues of interference, and before the European Patent Office, for issues of priority. It is sufficient to browse through the apps on our smartphones to glimpse the extent to which health data are collected through embedded sensors, connected wearable devices or direct input (see, for a recognition of this trend, the 21st Century Cures Act in the US), and stored in proprietary apps, with limited data-sharing capabilities.
As far back as 1998, a report of the Organisation for Economic Co-Operation and Development (OECD), entitled ‘21st Century Technologies: Promises and Perils of a Dynamic Future’ (OECD Publishing 1998), highlighted the key role played by information-sharing and knowledge spillovers in promoting socio-technical breakthroughs. The increased focus on standardisation, which features prominently in the legislative and political agenda of the EU and US, and the stronger emphasis placed globally on the intersections of competition and intellectual property rights, sought to address such concerns, with partial success. These attempts have proved fruitful in redressing imbalances in mature technologies, failing instead to shift the exclusionary approach that is typical of infant industries and technologies. Similarly, ancillary rules on data protection (including data portability, security and unauthorised disclosure), regulatory approval, interoperability and consumer protection seem to be struggling to cope with disruptive technological changes, especially where traditional applicability requirements such as stability (for regulatory approval) and dominance (for interoperability) are replaced by dynamicity and fragmentation.
Assessing the effects of the rigidity of the legal framework and its slow evolution vis-à-vis rapid technological changes requires a hypothetical analysis of potential strategic R&D choices that would in fact be influenced by a myriad of factors. However, there is growing endogenous evidence, within multiple industries, that the growth of infant technologies requires a new legal paradigm, characterised by an increased level of openness. This shift suggests the adoption of a broader definition of open innovation, focused not only on the sharing of technological breakthroughs, but also on the sharing of data and models within the industry, as well as with consumers, authorities and other interested third parties.
The centrality of open standards and interoperability in the growth of new technologies is also underlined by numerous examples of industry-led initiatives, which range from the new Open Neural Network Exchange Format initiative (onnx.ai), a community project started by Facebook and Microsoft to create an open ecosystem to represent deep learning models, to the open licensing commitments made by Tesla for autonomous vehicles technologies, to the Alliance for Open Media (AOM) dedicated to the development of next-generation ultra-high definition video formats.
The potential for revolutionary technologies to change the way we live and work depends, to a significant extent, on their ability to communicate with each other, to integrate and interact (any reader who has ever attempted to buy connected devices for her home, eg smart speakers or connected lightbulbs, has likely experienced this). Further, the investments needed to complete the initial development and deployment of such technologies require some form of collaboration and sharing, a principle usually acknowledged only after extensive litigation ending in inevitable cross-licensing. Finally, the evolution of the legal framework applied to such technologies depends on the sharing of data on their functioning and use with the relevant authorities (eg see the US FDA’s precertification program for digital health software) and the public (eg through explicit identification of the limitations of the technologies involved and clear rules on potential legal liabilities). In a time of revolutionary technological leaps, are we ready for revolutionary legal reforms?
Issue Section:
 Editorial
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