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The New Frontier: Neuroscience, Digital Health and Clinical Trials Part II

This is Part II of our blog series, The New Frontier: Neuroscience,… MORE

The New Frontier: Neuroscience, Digital Health and Clinical Trials Part I

Science is Data, Data is Science The world of science has always dealt… MORE

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The New Frontier: Neuroscience, Digital Health and Clinical Trials Part I

Science is Data, Data is Science

The world of science has always dealt in, traded in and relied on data. Data is the bedrock of all scientific breakthroughs, medical developments and drug discoveries. The scientific method revolves around the generation and analysis of data. Consequently, the ‘information economy,’ an emerging theme of the 21st century, is not particularly novel to a scientist. However, what is novel are the tools being utilised. Technological advancements and exponential improvements in computing power have fundamentally revolutionised tangible outcomes, methods, processes, and the potentials of the biomedical, biotechnology and biopharmaceutical sectors.

From bioinformatics and artificial intelligence (AI) to brain-computer interface technology and implantable devices, neuroscience research has embraced the opportunities and capabilities of new technologies. These transformations have allowed the sector to become more sophisticated, efficient, and cost/time-effective, facilitating the new generation and collation of datasets even more powerful and meaningful. While these transformations push the boundaries of medical research, they also raise serious concerns regarding data consent, protection and privacy.

The New Boundaries of Digital Health

Digital Health is quickly changing the face of the healthcare sector. The term ‘digital health’ is most often associated with the digitisation and the electronic connection of patient health data between points of care. This would ensure that all the healthcare professionals can access a patient’s medical information in a timely manner. Such an example is the Australian Federal Government’s introduction of ‘My Health Record’ in late 2018, which was subject to much controversy. There were concerns cited by data security experts and commentators from the healthcare sector about the safety of sensitive medical information and the potential for third parties, such as insurance companies, to gain access and to exploit the data therein. While legislation was eventually passed to ensure greater protections (such as a provision that barrs the use of data for commercial purposes), like any digital database, it remains vulnerable to security breaches.

However, digital health reaches far beyond this particular clinical setting. With emerging apps and platforms, and wearable and implantable technology, digital health is moving into unchartered territory. These new technologies are now able to collect, transmit, receive and process data. Examples include the PKG System developed by Global Kinetics, (a watch that assesses and disables symptoms of Parkinson’s disease), electronic patient-reported outcome (ePRO) platforms such as MoxyTech’s CLARAi technology which combine augmented reality, advanced sensor technology and deep learning AI, and currently in clinical trial development, a brain implant that could prevent seizures in people with epilepsy. However, not even these devices and platforms are safe from the same security concerns that have befallen ‘My Health Record’. Infamously, former United States Vice President Dick Cheney requested his doctors to disable the wireless functionality of his heart implant over reasonable concerns that it could be hacked.

“As technologies become more sophisticated, so do the ways to exploit their vulnerabilities,” commented Neuroscience Trials Australia CEO Dr Tina Soulis. “This is particularly pertinent to the field of neuroscience, considering the increasing number of medical devices being developed to help manage neurological diseases and conditions, such as epilepsy and Parkinson’s disease. Security protocols will be just as important as the functionality of a medical device or app.”

In addition to security, these emerging devices and platforms could foreseeably generate unprecedented volumes of intimate and vital data. This data could help scientists better understand the pathology of diseases and conditions, contributing to the development of improved treatments. As such, big data now plays a major role in many fields of scientific research.

With the General Data Protection Regulation (GDPR) in Europe and similar laws coming into effect in around the world, including the United States and Australia, the most pertinent questions being asked are: who owns this data that is being produced by wearable and implantable devices and new platforms? How effective are the protection systems that are in place? While the GDPR has particular exceptions for research, this highlights the importance of consent, ethics and compliance at all stages of the treatment discovery pipeline, from consent to participate in a clinical trial to donating data to research.

“Researchers who are developing new technologies that collect, transmit and process data must now consider these pressing questions of data security, device integrity and the ethical question of data ownership,” commented Dr Soulis. “It can no longer be an afterthought. This is now something we must test during the development stage and during clinical trials. It’s time for the innovation industry to take the lead and not wait for regulation to catch up to speed.”

This is Part I of our two part blog series on the emerging nexus of neuroscience research, digital health and clinical trials. Part II will be published next month.