Keeping pace with the health revolution
Technology is transforming healthcare research and delivery. But is the law keeping up? A new research team at Melbourne Law School is exploring the key legal challenges and opportunities.
The HeLEX@Melbourne team, from left to right: Dr Harriet Teare, Dr Megan Prictor, Associate Professor Mark Taylor, Professor Jane Kaye, Dr Carolyn Johnston, Dr Jessica Bell. Image credit: Paul Pasztaleneic.
Digital health records, genome sequencing and biobanks are at the vanguard of medical advancement, allowing researchers to solve health problems through technology in previously unimaginable ways.
But the increasing use of data from this technology, and the sheer volume of it that needs to be managed by researchers and organisations, throws up a raft of challenging legislative and ethical questions for health practitioners.
How do we keep human data safe? What is the ethical onus on clinicians and researchers when they discover information about someone’s genome? How should governments and corporations share this health information?
Enter the HeLEX@Melbourne team at Melbourne Law School, a new research program providing academic advice on law and best practice around the sharing and management of data generated from the use of digital technologies.
Professor Jane Kaye, Director of the Centre for Health, Law and Emerging Technologies (HeLEX) at the University of Oxford, established the program last year. Dr Jessica Bell and Dr Harriet Teare are the first visiting scholars from Oxford who are helping to establish the Melbourne arm of the research group. They have been joined by Dr Megan Prictor, Dr Carolyn Johnston and Associate Professor Mark Taylor.
“Our aim is to build synergies between Melbourne and Oxford and to use the skills and expertise of both teams to look at the legal aspects of these issues,” Professor Kaye says.
“This gives us a global perspective and our activities enrich both institutions.
We carry out socio-legal research, which combines legal analysis with empirical research, to think about the ways the law may develop, or change, in response to emerging technologies in health.
The research involves partnering with organisations to help frame policy and guidelines, including Stem Cells Australia, Australian Genomic Health Alliance and the Melbourne Biomedical Precinct. The HeLEX@ Melbourne team also have offices in the Victorian Comprehensive Cancer Centre.
Executive Chair of the Melbourne Biomedical Precinct, Professor Gareth Goodier, says the precinct’s close cooperation with HeLEX@Melbourne is based on a commitment to building a framework around digital health and big data.
“Things are moving so fast that we’re not sure what we will be doing with those tissue samples we have collected in five years’ time because we’re inventing entirely new techniques that we didn’t know about,” Professor Goodier says.
“What we are anticipating is a world in which we have all this information about our bodies, and our clinical record will be linked with our supermarket shopping, with our exercise profile, with our social health, and all sorts of other government databases.
“So I am interested in big data in a meaningful health world where we can get huge advances in our understanding of disease and mitigate disease.
“To get the benefit of all this data, we need to be able to share it, but we need to be able to share it in a framework that is legal and that protects privacy,” he says.
Professor Kaye says applying a scholarly approach is fundamental to ensuring safe, secure and effective frameworks are adopted by international organisations for managing data and genome sequencing.
“Rather than putting our finger to the wind and saying ‘we think we should do it this way’, we have looked at best practice and law in other jurisdictions as to whether, for example, clinicians should report back incidental findings when they do a genome sequencing test,” she says.
The area of genome sequencing, in particular, raises a range of ethical and legal questions, Professor Kaye notes.
“If you are looking at large parts of someone’s genome - that is possible with the new sequencing technologies - you may come across what is known as incidental findings. For example, you might discover that someone has a BRCA1 and BRCA2 [gene] mutation, which would then put them at higher risk of breast cancer.
So we ask, ‘what is the duty of care here?’ Is that care owed by the researchers who were looking at the sequence data, or is that owed by the treating clinician?
“And what is the obligation of the clinician to the other family members?
Because if I have a BRCA1 or BRCA2 mutation, that is passed down by one of my parents. This could also indicate the level of risk for my children, siblings, cousins or other biological relatives.”
Further issues are also raised by the prospect of artificial intelligence and machine learning, which could change the way people receive health diagnoses.
“The IBM Watson computer can potentially make better diagnoses than an individual doctor because it will have the information on hundreds of patients’ symptoms to compare,” Professor Kaye says.
“This raises issues as to what will be the role of healthcare professionals in the future, and how will that influence the legal standard of care?”
Then there is the thorny issue of data collected from the growing field of wearable tech.
HeLEX@Melbourne Senior Research Fellow Dr Carolyn Johnston is investigating how data from emerging technologies is to be ethically managed and what legal duties may emerge.
“If a child comes home from hospital and they are wearing a health device, for example to monitor blood glucose levels, then that device will have data on it,” Johnston says.
“Families may then contact the hospital and ask ‘what does this information mean?’
I am interested in the legal and moral duties of pediatricians to respond to the families contacting them and how they balance the time taken to do that with their duties to inpatients they care for.
Fellow HeLEX@Melbourne researchers Associate Professor Mark Taylor and Dr Jessica Bell are similarly focused on information governance in relation to health data.
Bell, in particular, is looking at how best to manage the sharing of the vast repositories of human tissues and samples stored in biobanks.
As Bell notes, different types of public and private organisations want access to health data, and they want data for different reasons.
“Access has been controversial, generally, as to whether commercial companies can have the same access to sample repositories that a public interest researcher has.”
This is where the concept of ‘dynamic consent’ comes into play, an idea developed by Professor Kaye and others, to enable people to consent to the use of personal data and human samples when, for example, the scope of a research project widens. With dynamic consent, people can access an online website which gives them information about how their personal data is being used, but also enables them to give new consents or to change their privacy preferences.
Owing to data breaches and concerns over companies accessing personal health data, there is understandable community concern over how much of our health information is shared.
But the HeLEX@Melbourne researchers all agree that the worst outcome of any community concern would be to shut down the sharing of information that could lead to significant health improvements and cures.
“In healthcare you expect that our data stays within the cocoon of healthcare and research, and I think it does,” Professor Kaye says.
“Also, I think the standards are higher than in other areas; I think people are very conscientious about how they use data.
“But we do have to work out what the standards are, what best practice is in terms of international collaborations and the whole open access agenda, which is very much about how data that is generated through publicly-funded research should be made available to others.”
By Johanna Leggatt