App development is a golden opportunity - but pharma companies need to be wary

Liz Ashall-Payne, founding CEO of digital health consultancy ORCHA assesses pharma's potential for digital apps and what the industry needs to bear in mind.

Since Covid-19 arrived, there has been a 25% rise in health app downloads, up from 4 to 5 million every day.  There has also been a 6,500% increase in healthcare professionals recommending apps to patients. Health tech experts acknowledge that the sector has advanced five years in the last 18 months.

Given this bow wave in enthusiasm for digital, it would seem logical for pharma to embrace what seems like a golden opportunity to engage with patients.

Apps which support medicine adherence, monitor blood pressure, help patients watch symptoms of long-term conditions and support healthy exercise and diet regimes are increasingly gathering evidence of a myriad of benefits – both to the patients themselves and to health services.

Pharma companies which support therapies with apps will not only be providing a valuable service, they will be differentiating their products from those offered by the competition. Added to this, the potential to gather data on how medication is being used, plus the habits and preferences of patients, is massive.

And new research from ORCHA, the Organisation for the Review of Care and Health Apps, has found patients – the key, of course, as they must be on board – more than willing to embrace digital health in the form of apps. 65% agreed that they’d be willing to look at using more technology, such as health apps, as part of a fresh approach. Nearly half the respondents (49%) agreed that doctors should be able to prescribe health apps just like they prescribe traditional medicines. Of the 38% who had already used a health app, a striking 87% said they were satisfied with the experience (nearly 40% of those were strongly satisfied).

But there are serious potential pitfalls. As marketing collateral goes, app development is in a league of its own. The heart of the problem is that many apps are treated, for the purposes of accreditation, as medical devices and scrutinised as such. 

The MHRA (Medicines and Healthcare Products Regulatory Agency) has enforcement powers against non-compliant digital health products under the Consumer Protection Act (1987) plus the Medical Device Regulations (2002) and General Product Safety Regulations (2005). Companies failing to comply can ultimately be prosecuted, with consequences including unlimited fines or six months’ imprisonment. Added to this, under new GDPR regulations which protect data privacy, breaches can lead to fines of up to 4% of annual global turnover or €20m, whichever is the higher.

With apps costing anywhere between £250 and £1m to produce, the stakes are high. A robust project plan is needed from the outset.

Project managers should start by taking a deep look at the market. What are the politics of the sector, what is health service policy, what other apps are out there, what works and doesn’t work?  Crucially, what are your competitors doing? The objective of this exercise is to the find the gaps.  For example, there may be many apps supporting a patient through a particular condition but none which support family and friends in a helpful way. Should you be supporting them?

Once you’ve found the USP for your app, next think about a checklist of what you must include. Think about user centred design, what healthcare staff may be looking for, where the app sits in a care pathway, and whether you are able to collect key outcome data such as PREMS and PROMS.

As the app is constructed, your checklist should include a water tight privacy policy adhering to GDPR and complying with all data standards.  You will need to show clear evidence of the professional assurance behind your app. Is there evidence of a clinical trial? Is everything you claim correctly referenced? Health apps can be complex medical devices, they can do harm as well as good if clinical safety is overlooked.

Next, consider if your app can be hacked. Cyber security is part of the government’s new DTAC (Digital Technology Assessment Criteria). And finally, interoperability is key. This means if your app connects with the NHS patient data records, the connection must be safe and secure. With all these aspects in place, your app is ready to be accredited by the DTAC.

So now you have your app, but one of the biggest challenges is ahead. Your app must not be allowed to languish in dark corners of the app store. How are you going to make sure healthcare professionals are aware of it and use it?

Distribution is key. You may want to create marketing assets for your reps to use or get your app into a commercial app library. The benefit of an app library is that the app is reviewed whenever standards change or when the app is updated.

For those considering an app, when you boil down some of these complex issues, the key questions are: is your strategy right, have you built the best product and have you avoided non-compliance?