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Healthcare transformation and innovation

The healthcare and technology revolution


Healthcare today is undergoing a serious change that will affect our lives in the future. The rapid evolution of technology and tech applications is altering many different industries, and healthcare does not make an exception in this process of transformation. Advances in technology change the way we approach healthcare, creating new opportunities in areas like digital therapies, health technology or health insurance innovation.

Both healthcare and technology industries are extremely broad and complex, and it is difficult to keep up with everything that is taking place within those realities on a daily basis. Healthcare problems are transforming; thus new solutions are vital.

One of our goals for the Frontiers Health conference, which took place late last year, was to organise an event that would let people from the different fields of healthcare and technology build a common picture and understanding of how new medicine and health technology are replacing traditional silos to positively shape the global health situation. Of course innovation alone cannot transform healthcare and the role of healthcare policy and the regulators that can inform and help guide the process of innovation towards adoption are also important, and to that end, we made sure that the regulatory angle was also well-represented at the event.

The EMA’s approach to digital health

Marisa Papaluca is the European Medicine Agency’s senior scientific advisor to the regulatory science strategy of the scientific committees, and was one of the presenters at the Frontiers Health Conference. During the event, she gave an insightful look at how digital health and innovation are playing a key role at transforming the regulatory mission of the agency.

Marisa explained that the European Medicines Agency is fully engaged in digital health as a medicines regulator because it recognises the great potential that digital health will have in transforming medicine itself. As a result, the agency has begun to provide guidance for situations that are difficult to tackle because of the completely new ways of sourcing and generating data, which includes the ability to measure new things in life sciences that will one day be studied and that will generate a wealth of new medical knowledge.

The agency’s shift to recognising the value that data will have in healthcare had its beginning in wanting to find a practical way to improve upon the drug review and approval process which, in the past, involved the submission of thousands upon thousands of printed pages of information. From July 2013, in the context of the International Conference on Harmonisation of requirements for medicinal products marketing applications, the Agency and the regulatory network moved from paper to a mandatory submission of the Common Technical Document whereby all data is electronically submitted, reviewed and stored. Since then, relentless progress has been made to progress data standards to make this data actionable by both regulators making approval and supervisory decisions, and scientists who may want to leverage it in future research.

Non-commercially confidential data submitted and stored at the Agency was made accessible via a relevant transparency law for Access to Documents and more recently via the policy decision to make available the clinical reports of the studies submitted.

Marisa went on to describe how a data-driven healthcare paradigm has become the mission of several important research efforts such as The BRAIN initiative, launched in parallel with the US, In silico Trials Networks, the Physiological Me, etc.

Massive data collection, she explained is also emerging as a way to better define clinical outcomes based on digital measurements that are unprecedented and completely new, but that can now be contextualised around the existing medical outcomes data that has been accumulated over time.

Marisa went on to explain how the European Medicines Agency has always had a strategy of partnering with all the traditional stakeholders in the medical policy arena, and found itself working closely in areas around patient awareness, empowerment and interaction, healthcare providers and, more recently, academia and primary care physicians, mostly driven by the need for the regulators to be collaboratively involved in the areas where health innovation emerges.

“We are not fundamental scientists or researchers, but we do want to make sure that the methodology for regulatory evaluation and decision-making is science-led so that the results are actually in line with assuring that a positive benefit/risk balance is achieved,” she said, and further emphasised that, while in the past safety was the principal driving element for regulatory post-approval activities, the mission has shifted to also include efficacy as an important aspect of pharmacovigilance for any medicinal product reviewed. “We look closely at efficacy outcomes in post-approval as a determining factor, to confirm a positive benefit/risk balance, because a drug may be safe but if it does not achieve its results in the clinical health setting, we have the ability to pull that drug off the market, which might not have been the easiest case before new pharmacovigilance legislation was adopted in Europe in 2010.”

This thinking might also apply to digital health therapies that will need to prove that they are providing clinically relevant measurable outcomes, and not just passing a safety profile before being approved.

Whereas this might be seen as an increased challenge to meet, access to vast healthcare data from multiple sources will actually improve the agency’s ability to gauge efficacy and safety where before this was not possible, continued Marisa. She then emphasised that access to the same data will actually help the developers of digital health solutions to investigate new areas of need in health, and to come up with novel approaches to address this need.

According to Marisa, one of the paradoxes of the healthcare industry that the agency is trying to reconcile is by being completely focused on helping to bridge the gap within an industry that wants to be innovative, yet conservative, and is willing to minimise regulatory risk at the same time. She described this paradox as something that has been defining the pharma industry for a long time, and that she sees the agency’s ability to provide the right kind of guidance and support as critical in helping the entire industry move forward in this new digital and data-driven world.

Marisa concluded her remarks by presenting her own long-term personal vision of the work that the EMA and the European Medicines Regulatory Network are doing in bringing forth the development of cures, both traditional and digital; a vision centred on the convergence of policy, innovation and data that she foresees will somehow contribute to populating a cloud and ultimately also the proposed United Nations Science Cloud. The cloud will eventually result in a repository of available scientific information and will allow access to invaluable data and opportunities for research and health policy implementation across the globe. Marisa stated that the EMA is making sure that the work currently being done to implement the Regulators’ telematics strategy in Europe specifically follows four guiding principles around the collection, classification and storage of data as well as regulatory evaluations. The robust and reliable data on which regulatory decisions are made must be findable, accessible, interoperable and reusable.

The European Medical Agency’s implementation of the telematics strategy on a European level can be also seen as a concrete first step towards eventually offering knowledge to the Open Science movement. Marisa expressed her dream to see the day when this growing data set will be expanded beyond the European context, and that all efforts will have been used for the benefit of all humanity.

The necessity of innovation

Following Marisa’s presentation, Healthware International’s CEO Roberto Ascione took the stage and pointed out that the new approach at the European Medicines Agency illustrates how innovation has become a necessary component to finding solutions to the growing number of challenges that global healthcare is facing today; innovation in itself is not the goal, but rather a tool that is supposed to help us shape the industry in a better way, and make significant progress. Technological innovation should allow for a major shift in healthcare, aimed at abandoning obsolete methods and embarking on a new digital approach to health. All of this requires a lot of work and coordinated effort. The healthcare and technology revolution is a continuous process, and we should follow developments in the industry and stay connected with each other.

Article by
Gerry Chille

is a partner at Healthware Labs

1st May 2017

From: Healthcare



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