Digital transformation in life sciences is creating opportunities to counter healthcare’s most intractable problems from treating rare diseases to accelerating diagnostics and reducing treatment backlogs.
But technological advances are outstripping legislative and regulatory frameworks giving rise to a landscape strewn with issues over data, privacy and IP, the recent CMS Global Life Sciences & Healthcare Forum 2022 heard.
“Technology change obviously brings with it risks in implementation and new uses of technology and new regulation and legislation brings new risk,” Jeremy Mash, partner at CMS London, told delegates.
AI is a potent force in life sciences with machine learning and patient data opening up new opportunities to revolutionise healthcare and relieve systems bogged down by laborious processes and shrinking budgets.
The advances are welcomed across life sciences and digital has been enshrined in most nation’s health system planning but some fundamental principles such as who owns or is responsible for patient data, new routes to treatments and the consequences of mistakes have yet to be fully tested.
“There are situations where you can see that evolving into risk and legal problems,” added Jeremy. “There is increasing use of legislation in the space and there is concern about where it is going to lead. There are a lot of data issues about quite what the ‘black box’ is doing and you can see people starting to raise concerns about how their data is being used.
“There is also a lot talk about who is liable if that AI does not work. Is it the person who implemented it or the person designed it?”
CMS examined the emerging issues in its Technology Transformation report, which surveyed 510 senior counsel and risk managers across sectors and discovered a range of preparedness and safeguards.
It identified that IP issues represent 65% of expected future technology disputes, observed Jane Hollywood, partner at CMS London and patent attorney. She said the existing risk management systems for identifying, analysing, reviewing, mitigating and monitoring IP risk may need stiffening.
“It's one thing to have contractual obligations and training for your people governing how you protect your IP and not misuse third party IP,” she told the Forum, in Brussels. “But it's quite another to ensure that your procedures remain adequate while you're operating in a world of machine learning algorithms and AI facilitated decision making.”
She added: “The IP system does not evolve as quickly as technology advances and therefore we can have challenges obtaining protection for new technologies. We've seen this very much with AI and digital health technologies where patent protection can be difficult to get.”
She said that identifying ownership and capturing developments in a fast-moving sector where collaboration and joint ventures are common can also generate disputes.
“Big Pharma is increasingly partnering with digital health companies for drug discovery and patient engagement and clinical trial automation and, again, there's a lack of clarity about who owns the data that's generated from these partnerships so this is also likely to lead to disputes in the future,” said Jane.
To Read the full survey, visit here.