In this wide ranging interview we discuss the future of remote patient monitoring (RPM) software and government progress in ehealth. Through its RPM platform, Huma claims to massively cut costs and improve outcomes for patients with chronic conditions.
In March 2023, the EU granted Huma the world’s first and only multi-condition Class IIb approval for its device-agnostic, configurable Software as Medical Device (SaMD) platform. This was followed in June by a similar level of regulatory clearance by the US FDA, called 510-k Class II. Huma has raised $217m and shareholders include Bayer, Hitachi Ventures, Samsung Next, Sony Innovation Fund and Unilever Ventures as well as individuals Nikesh Arora (former president of SoftBank) and Michael Diekmann (Chairman of Allianz).
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HBI: So what exactly does Huma do?
IO: We are a digital-first company that works across healthcare and medical research. In terms of remote patient monitoring (RPM), we provide a platform that tracks patient vital signs remotely and presents these through a clinician-facing dashboard which allows a doctor or nurse to monitor and manage the several patients at once. Take heart failure, for example. Specialist doctors decide on what vital signs to track and these are then entered manually by the patient at home or via bluetooth-linked devices. Because the patient isn’t waiting for a clinic visit to have their vital signs monitored at intervals, measurements can be taken almost continuously in the real world setting, giving a truer picture of the patient’s condition. The software platform then tracks these measurements and alerts doctors if they move outside the parameters set by the clinician for managing the disease The platform can also operate in the other direction and send messages to the patient, advising them what to do on a daily basis, serving up questionnaires about their health and symptoms so that this can give a broader picture of their health, whether they are taking their medication etc. All this can be linked into bigger patient record systems.
HBI: So what is the significance of the recent EU and US FDA approvals?
IO: When we gained the EU approval, we were the first disease-agnostic platform to be given Class IIb approval. Together with our US FDA (510-k) Class II clearance and Class IIb registration with the UK MHRA, I believe we now have the broadest geographical reach of any such digital health platform. This level of regulation allows us to monitor patients of all ages, including children, and also during pregnancy. It also allows our platform to accept artificial intelligence (AI) algorithms. This is important because AI has the potential to augment RPM technology by allowing the earlier detection of signs of patient deterioration and we are working on this very function with some of our partners–the worsening of disease symptoms that predict a downturn in a patient’s condition. Of course, the outcome is always overseen by a doctor or nurse, so there is always a human-in-the-loop.
HBI: So does all this patient monitoring software work?
IO: Absolutely. During COVID, and working in Germany, we were able to show that regions which used Huma’s platform to manage COVID patients had mortality rates 3-4 times lower than non-monitored patients.
HBI: 3-4 times! That is almost unbelievable.
IO: Well it is a published paper!1 The problem with unmonitored patients with COVID was that those who were worried would come into hospital with minor or no symptoms – where they would promptly catch the virus! Conversely another group of patients would stay at home with severe symptoms and leave it too late to come to hospital. Once there, they would be promptly put on mechanical ventilators, which we now know had very poor outcomes.
HBI: So COVID is an extreme case.
IO: It’s just a simple example. We work across a large range of conditions. With NHS Wales, for instance, we have shown we can keep heart failure patients at home longer and, because we are regularly monitoring their vital signs, we avoid emergency visits. Typically, it would take around 4-8 months previously to ascertain the right dosage with patients travelling in for appointments. With the software giving daily readings, you can titrate it within a month and avoid emergency room visits. Patients prefer this and have better outcomes generally2.
HBI: OK and so who are you competing with?
IO: Well in most countries now I think you will find a few small players. In the UK we compete with Luscii from the Netherlands and with Current Health owned by Best Buy, a big US tech retailer. Then we have Docobo, owned by UK healthcare software vendor Graphnet, which is owned by private equity house CVC.
HBI: What about the majors?
IO: Optum in the USA, but not in Europe, Epic and Cerner claim to have this sort of capability and Google has something within Alphabet. Apple’s offering is more consumer oriented. In general, the majors have been slow to the party.
HBI: So there has been a sea change with COVID, hasn’t there? I was talking to a small Belgian player who said that specialist doctors in oncology and cardiology are now really keen on patient monitoring. He said there has been a complete change in attitude thanks to COVID with kit getting into a hospital within a week of the first sales call.
IO: Yes that is true. We went up a very high growth path in COVID and, although things have steadied since then, interest and the market is still growing.
HBI: So who do you sell to?
IO: I guess there are two main buyers. You’ve got big pharma who use the technology in clinical trials and to generate real life data and hospital trusts who use it to monitor patients.
HBI: And are they similar in behaviour?
IO: No! Pharma is very enthusiastic about digital technology and is very keen to build a digital offering to differentiate themselves and increase loyalty. They also have a strong vision; for instance, they will be much more likely to use bluetooth to link devices rather than making the patient do manual entry. Monitoring software alerts doctors that drugs need readjusting for better control of disease. The platform can also be used to expand the reach of clinical trials by recruiting a much more diverse audience at a distance from the trial site, and to generate real world data after approval of a medicine when it’s on the market and being used by patients.
Health authorities are perhaps more conservative . They tend to rely on manual data entry by patients, for instance. They are averse to staff using up valuable time compiling daily reports instead of delivering care. We have to show them that they will save a fortune on less nursing time in emergency rooms!
HBI: So you have to prove a very different business case?
IO: Indeed. And you have to understand the payor system as well. Germany has reimbursement for remote monitoring, so does France. In the UK, virtual ward funding isn’t established. US hospital systems remain activity-led so you have to show that using the software will enable them to pick up fees they wouldn’t have access to otherwise.
HBI: So how much does it cost?
IO: It can be as little as £100 per patient per annum for the software licence. The actual process of monitoring of patients is where the expense lies. At the moment, we are focusing on the UK and the USA markets so that we grow without spreading ourselves too thinly.
HBI: I remain amazed that so many countries allow publicly funded bodies to choose their electronic medical record system. NHS England should be specifying a single platform.
IO: I hear what you are saying but that isn’t actually necessary. Better is for the government to insist on formats and interfaces and allow competition within that. Denmark has done this and so too I think has Dubai and Abu Dhabi.
In any case, all EMRs are tailored to the workflow of the customer organisation. Two implementations of Cerner can be very different so deep integration tends to be an expensive one-off project.
HBI: So do you link your monitoring software into electronic patient records?
IO: Yes we can.. But you have to ask how relevant a lot of the data is. Often there will have been months between patient visits. With our software usually doctors specify the vital signs they need to monitor and we provide that on a daily or several times-a-day daily basis and that is what you really need to control things. Oftentimes, we are selling an almost standalone offering.
1. Lim et al., An Outpatient Management Strategy Using a Coronataxi Digital Early Warning System Reduces Coronavirus Disease 2019 Mortality (2022); Open Forum Infectious Diseases, Volume 9, Issue 4, April 2022, ofac063.
2. Remote Cardiac Patient Monitoring Pilot launched in Wales (2021) https://lshubwales.com/news/remote-cardiac-patient-monitoring-pilot-launched-wales
We would welcome your thoughts on this story. Email your views to Max Hotopf or call 0207 183 3779.