Out-Law News 4 min. read
22 Oct 2020, 4:51 pm
Speaking at an online event on connected health hosted earlier this month by Pinsent Masons from Dublin, Dixon said codes of conduct, which are open to industry bodies to develop under the General Data Protection Regulation (GDPR), have "huge potential" and could deliver a wide-range of benefits to organisations across life sciences.
"Data-driven health has a lot of complexity to it even before you get as far as AI," Dixon said. "I think codes of conduct would allow development of very specific data protection rules targeted to this sector. It would provide for an important engagement between data protection regulators and the industry sector as well where there is mutual learning and engagement. As well, importantly from the industry point of view, it creates a type of level playing field where we have all of the actors signing up to it."
"There is a big advantage as well under the GDPR in terms of the provisions on codes of conduct in that they provide for an independent third-party monitoring body in relation to the data protection rules that they impose, so patients or data subjects would have an additional place where they could bring a complaint and have it dealt with. Codes also help engender that top-down leadership because, importantly, it is not regulators that will impose a code of conduct on a sector, it is up to the sector to come forward and to sign up for it, and I think it speaks to enlightened organisations realising that data protection can be a differentiator and can be a competitive advantage, all of which feeds into the need to have legitimacy and obtain a 'social licence' [for digital health projects]," she said.
Dixon outlined her views on the prospect of GDPR codes of conduct in life sciences after Janice Carling, lead privacy counsel at Teva Pharmaceuticals in Europe, told event attendees that EFPIA, the European Federation of Pharmaceutical Industries and Associations, is leading on the development of a new pharma code of conduct, with a view to it being endorsed by EU data protection authorities. Carling said the idea of the proposed new code is that it will address the areas of scientific research and pharmacovigilance, and that it would help businesses better understand and meet their obligations around data protection in the context of their wider regulated activities, including in the context of compliance with regulations on medical devices and clinical trials.
"Agreement and approval for this code would offer an additional security and confidence to the already regulated activities in which pharma companies are already following while offering some degree of harmonisation amongst member states so that our time can be better spent on the higher goal of creating a better and healthier society for our citizens," Carling said. Other codes of conduct in areas of cloud computing and mobile health are also under development, she said.
According to Carling, there are two main barriers to data-driven digital health innovation currently: tight restrictions on the transfer for health data across borders, and "uncertainty and lack of harmonisation" of rules around the secondary use of health data.
"Secondary use of health data refers to the use of data for a different purpose other than for the one it was originally collected," Carling said. "In the health sphere, it typically involves the use of electronic health records, health insurance claims data, registry data, drug consumption data, for medicines research and public health purposes normally. To be able to share data for clinical, safety or quality research, for observational studies, to monitor the natural course of outbreaks or diseases, to understand better various diagnoses, to develop orphan medicines – all of these and more – rely on the secondary use of health data. However, in practice, legal complications and inconsistencies across member states and amongst the various parties involved in health data poses a real challenge for the industry."
Personalised medicines and digital therapeutics in all their guises that use customer-friendly, data-driven approaches, supported by advanced technologies, are going to transform health care as we know it today
Frank O’Donnell, public sector lead with Microsoft Ireland, said that the technology company works with a number of partner organisations that rely on its digital infrastructure to deliver health care solutions. He said the role of artificial intelligence (AI) solutions in health care has grown over the last 18 months, but stressed the strict governance mechanisms that should be put in place to ensure its ethical use.
"We have established a lot of internal governance around AI and set up advisory committees internally as well," O'Donnell said. "In any AI endeavour we assess the degree of sensitivity around AI use – and in health care area this is a really sensitive area, but then it becomes something that needs to be analysed in terms of the kind of principles that we feel need to underpin AI. That may be things like fairness, transparency, accountability and inclusion. Having those founding principles in place are really critical to any growth in AI and to doing things in the right way."
Something we have to do to make health care systems sustainable is we need to somehow reduce some of that demand, particularly on acute care where it is so expensive and in some countries still quite limited in terms of availability
O'Donnell said, though, that the concept of connected health covers a wide-range of different things, and that even relatively basic technological interventions can make a real difference.
He said: "We know that patients who are more engaged in their own health and their own wellbeing, prior to maybe ever needing care, is an important aspect in terms of reducing demand on health care systems. Something we have to do to make health care systems sustainable is we need to somehow reduce some of that demand, particularly on acute care where it is so expensive and in some countries still quite limited in terms of availability. We see that from some of the devices that people use, but we also see increased technology use in terms of simple things like appointment bookings or reminders about appointments. If you see the level of 'do not attends' that happen in some health care systems and the capacity issues that causes, then improving something like attendance rates again frees up capacity in health care systems."
Dublin-based Ann Henry, who specialises in data privacy in the life sciences sector for Pinsent Masons, said that Ireland is an attractive jurisdiction in which to develop connected health solutions. The country is the seventh largest exporter of pharmaceutical products and devices in the world.
Henry said: "There are a lot of amazing changes coming to life sciences over the next few years – AI, data analytics, digital tech, genomics, our better understanding of the biology of diseases and people. All of it is leading to the development of complex drugs for complex ailments at much shorter developmental lifecycles. Personalised medicines and digital therapeutics in all their guises that use customer-friendly, data-driven approaches, supported by advanced technologies, are going to transform health care as we know it today."
Cerys Wyn Davies, also of Pinsent Masons, said that life sciences companies and technology providers that are willing to share intellectual property (IP) and risk in collaborative contracts can cut down on the time it takes to get new digital health solutions to market, and further flagged the potential of 'data trusts' to enable responsible data sharing to support innovation in health care.
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