MHealth and clinical governance

Mhealth is mobile technology that can have many useful applications, such as remote monitoring. In developing this technology, what issues must vendors consider in relation to clinical governance? In other words, how can they ensure the safety, quality and clinical benefit of their product, and mitigate the risk of harm?

Firstly, clinical governance is not just about frameworks. Clinical governance goes to the very heart of care, and how we manage risk on an ongoing basis.?Therefore any mHealth product in itself should be a component or enabler of clinical governance. Remote monitoring, for example, is about clinical governance - it allows the early identification of risk.

Clinical governance, no matter the context, ultimately concerns consumer outcomes (subjective and objective) - so it's logical that consumers should be at the centre of all approaches to clinical governance. Developers must therefore address, on the basis of evidence, what is important to their target demographic (one size does not fit all). By ensuring benefit, we also reduce the risk of harm. So vendors need to ground their product in a robust understanding of what their potential customers need, and want.?

The purpose of the product must also be clear, in terms of outcomes (not just outputs). To this extent, developers should work with clinicians in enabling mHealth to support effective partnerships with their patients. While mHealth solutions can be useful tools (for example, by allowing the early recognition of clinical deterioration), they must ultimately facilitate care.

As such, co-design is essential to developing a product which places the consumer at the centre of clinical governance and supports clinical partnerships. Extensive, holistic and early consultation is crucial.

In line with this approach developers should also consider, from the outset, how their product fits within regulatory frameworks such as therapeutic goods and privacy/health record legislation.?They need to understand their obligations, constraints, and legal risk – and develop their product on the basis of this understanding. Any risk is better managed prospectively than retrospectively.?It therefore makes sense to also collaborate with lawyers/advisers in the process of developing the product - not after. Given a key role of regulation is to prevent harm, compliance is a contributor to clinical governance.

For example, a privacy breach can cause harm. I have met many developers who deferred seeking privacy input until they had the 'finished product'. This is the wrong way around - akin to investigating what consumers want after the product has already been built. In the case of privacy, it can be a complex exercise to retrospectively unravel information flows, and developers risk having to 'undo' work if non-compliance is identified - it is also generally more expensive to do things backwards.

Clinical governance is a dynamic process. We need to be constantly thinking about what the product is trying to achieve (does the user understand this?) - constantly reviewing its limitations and risks, and considering at what point human intervention is required (how is this communicated to the user?).?Returning to the example of remote monitoring, developers must not only identify what parameters should be measured and why, but how they translate clinically, and what the ‘trigger points' are. This means understanding how these parameters compare against a user’s baseline - and how to manage natural (non-pathological) changes to this baseline, as will occur with ageing.

Finally, are there potential ‘nocebo’-type effects with technology??Can the use of mHealth have a negative psychological or behavioural impact??A friend once suffered from episodic palpitations due to SVTs, with no cause to be found.?After again presenting to ED and having an organic cause excluded, the doctor advised her to stop looking at the wearable which monitored her heart rate - he considered this to be the cause. Was he right? Does mHealth create new risks, and how are these manifesting?

In summary, we need to immediately shift from a clinical governance paradigm conceived of rigid frameworks, to clinical governance being an iterative process - flexible, responsive, and adaptive to changing needs, wants, and emerging risks. This is how clinical governance can embrace technological innovation – because, in purposeful alignment with mHealth, clinical governance is about improving safety, quality and efficiency of care.