Regulatory challenges and involving clinicians in the health tech industry

Regulatory challenges and involving clinicians in the health tech industry


Although health tech and digital health startups have much to offer in terms of transforming healthcare, they often face the challenges of overcoming regulatory hurdles, which are especially stringent in healthcare for the safety of patients. In addition, clinicians can often be torn between being in medical practice and being involved in health tech innovation/research, particularly for those in the public health sector in Singapore.

An outcome-based approach to regulation

A concern that was raised was how regulatory bodies, such as the Ministry of Health would approach regulation in an age in which innovation can outpace regulatory developments/changes.

“One of the ways that regulations have been changing over the last 20 years across the world is moving away from a prescriptive approach in which there are a given amount of people and systems in place at the hospital. Instead, an outcomes-driven approach should be taken in how these outcomes can be achieved and assessing if the means are the gold standard or best practice.

The reason we are doing this is that there may not be a right answer for everyone. There are many ways to achieve the desired outcome – by being very strict with the regulations, we then kind of stifle innovation and that’s why this outcome-based approach is very important,” said Mr Praveen Raj Kumar, Assistant Director (Engagement Strategy), Ministry of Health, Singapore.

Bridging the gap between clinicians and the health tech industry

Another question was raised on how clinicians can juggle between commitments at their respective healthcare organisations, such as public hospitals and being involved in the health tech industry.

Dr Yau Teng Yan, Chief Medical Officer, Holmusk, who was formerly a practicing clinician in Singapore before entering the health tech industry full-time, explained:

“Many of the digital health companies, especially in the US, many of the founders are still in clinical practice and it is possible to juggle both. I think it is important for healthcare technology companies to bring in clinicians in terms of conceptualising the product, etc. There are a lot of very smart people outside of the healthcare industry who have very good ideas but without bringing it into the clinical context and understanding how the healthcare system works, a lot of these products which may be very innovative are unfortunately doomed to fail because there’s no right model of bringing it into the healthcare system.

If there’s a way that clinicians could carve out some of their time, I’m not sure how possible it is in the public sector, to spend some time in the industry and work with different innovators, it is an ecosystem and everybody had to work together, not just developing products in isolation.”

Ms Pang Sze Yunn, Head, Population Health Management, Philips ASEAN Pacific, added that there are different ways that clinicians can be involved in the private sector to develop new products. For instance, Philips collaborates with doctors, both from the public and private sector, sometimes in their personal capacity, because the hospitals have allowed them work with the company for specific projects or products. 

Integrating digital health data into clinical workflows and decision making

A challenge faced by clinicians is that although data from digital health platforms/devices is available, it does not necessarily mean that they are going to integrate it into decision-making. In response, Dr Yau shared that it is indeed very difficult and it is very specific to countries and organisations.

In the context of Singapore, a lot of the IT needs in the public healthcare sector are administered by IHiS, the national healthcare IT agency. Dr Yau had several conversations with IHiS to talk about integration and it does require meeting some of their technical requirements as well as some of their security requirements for data before data can go from devices, wearables, mobile apps into their EHR systems. In the current exploration, it does require a sizeable amount of do something like this.

In the private sector, however, there are certain opportunities to work with EHR vendors, as some of the systems are more open to ‘pulling’ data from various sources. 

“I think this is what the current landscape looks right now, especially because of EMR systems that have been developed 10-15 years ago. When they have been developed, their focus was not on actually helping doctors work in the best way but rather on how they can bill patients in the best way, capturing billing codes and so on. In the next five to ten years or so, the new age EHR systems will be a lot more interoperable and the data from all these different sources can be pulled in a meaningful way to the systems. And that’s where we can actually see an integration of all these data,” Dr Yau observed.



Source …

Share this page...
CBDPet CBD Hemp Oil Extract Dietary Supplement

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.