Fixing the foundations: building a solid evidence base for digital health
Just as a building needs secure foundations to stay strong and stable, healthcare innovations should be underpinned by solid clinical evidence showing that they are safe and make a difference to people’s lives.
For conventional medicines, this evidence base is built from long-established building blocks of preclinical data, clinical trials and regulatory approvals that can take years to assemble. But in the booming world of digital health, the same rules don’t always seem to apply.
A recent study of more than 200 US digital health startups1, led by digital health investors Rock Health, revealed that nearly half had no clinical data or FDA filings to back them up, with just 20% of companies making up the bulk of the evidence provided.
Meanwhile in Europe, the Medical Device Coordination Group (MDCG), which advises the EU on the regulation of novel digital health technologies, has warned that more than 90% of the provisional approvals2 for medical devices granted on the basis of minimal clinical data are due to expire in 2023-24. More than half of the full regulatory applications for these products are currently incomplete, suggesting that sufficient evidence is yet to be gathered.
That’s a big problem, not only for the patients and clinicians who rely on these technologies, but for the health tech sector as a whole. Unless companies step up and produce solid clinical data demonstrating the foundational safety and effectiveness of their products, there’s a risk that the market for digital health - together with public confidence and trust - could start to fall apart.
Let’s get rigorous: measuring clinical robustness
It’s easy to ask that digital health products demonstrate evidence supporting their claims - often referred to as clinical rigour or robustness - but much harder to know what this should look like in practice.
In their study3, the Rock Health team combined the number of registered clinical trials and FDA filings from each company together to produce a measure of clinical robustness, which they could then compare against the number of health claims being made.
Another approach would be to look at the number of peer-reviewed papers published about a particular company’s product or technology. However, publication isn’t necessarily a guarantee of research quality or reliability, and the increasing tendency to ‘salami slice’4 one study into multiple publications can also inflate the tally.
More formal frameworks, such as CONSORT-EHEALTH5, aim to provide a more comprehensive checklist for reporting and assessment of the evidence supporting digital health tools. The World Health Organization takes a broader approach when it comes to assessing digital health interventions6, suggesting that regulators should look at the overall strength of confidence in the data about a particular technology and make adjustments according to the scale and scope of the product.
Reassuringly for Huma, of the roughly 40 peer-reviewed studies we have published about our technology, the majority are rated as good according to the WHO criteria - the second-highest ranking available. This reflects the fact that the highest rating is only awarded to multi-centre randomised controlled trials, which can be the most expensive and time-consuming study types.
Embedding clinical rigour into digital health at Huma
Here at Huma, we take the clinical robustness of our platforms seriously. The two of us have recently stepped into new senior positions dedicated to generating evidence and ensuring clinical rigour, as Global Clinical Directors of Evidence Generation & Information Governance (Arrash) and Patient Safety & Quality (Peter), bringing more than 25 years of clinical experience between us.
We’ll be working together with clinicians and patients to ensure that their voices are heard by our technical development team so we continue to create digital health solutions that truly connect people to the care they need.
We’re fortunate to have our in-house clinical colleagues on hand, and are developing plans to set up patient and clinical advisory groups to get broader insights. We’ll also be keeping a close eye on the scientific literature and changing landscape around digital health regulation, to make sure we’re getting it right.
Huma is committed to evaluating our projects and sharing what we learn with the people who need to know. This is something we bake in from the start of every study, creating a prospective evaluation plan for how we’ll gather evidence and assess whether something is working before a single patient is recruited.
It’s a strategy we’ve used to good effect for our ‘hospital at home’ platform. Rather than simply give our partners the technology to run virtual COVID-19 wards in Germany and let them get on with it, we agreed with them how we would measure success.
We were able to show that hospitals using the platform had up to four times lower mortality rates, 40% shorter hospital stays and the technology reduced patients’ need for intensive care, generating robust data that was then published in a peer-reviewed journal7.
The future of digital health is evidence-based
Digital healthcare is a relatively new and fast-growing industry in an ever-changing technological and regulatory world. The decisions that we make now will shape our industry for years to come, for better or for worse.
As the sector grows, we have a duty of care to do our part to ensure that it is as healthy as we wish our patients to be. At Huma, we’re committed to generating robust clinical evidence that builds trust in these transformative tools and technologies, and to sharing our results with the digital health community and the wider world to help people live longer, fuller lives.
- Day S, Shah V, Kaganoff S, Powelson S, Mathews SC. Assessing the Clinical Robustness of Digital Health Startups: Cross-sectional Observational Analysis. J Med Internet Res. 2022 Jun 20;24(6):e37677. DOI:10.2196/37677.
- Directorate-General for Health and Food Safety 2022 MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements [Online] Available at: https://health.ec.europa.eu/system/files/2022-06/mdcg_2022-11_en_0.pdf [Accessed on: 28 July 2022]
- Day S, Kaganoff S, Ryan R 2022 Stacking up against the clinical robustness index: A primer [Online] Available at: https://rockhealth.com/insights/stacking-up-against-the-clinical-robustness-index-a-primer/ [Accessed on: 28 July 2022]
- Elsevier Factsheet: Salami Slicing 2019 [Online] Available at: https://www.elsevier.com/__data/assets/pdf_file/0011/653888/Salami-Slicing-factsheet-March-2019.pdf [Accessed on: 28 July 2022]
- Eysenbach G CONSORT-EHEALTH Group CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions J Med Internet Res 2011;13(4):e126. DOI: 10.2196/jmir.1923
- World Health Organization 2016 Monitoring and evaluating digital health interventions: a practical guide to conducting research and assessment [Online] Available at: https://apps.who.int/iris/bitstream/handle/10665/252183/9789241511766-eng.pdf?sequence=1 [Accessed on: 28 July 2022]
- Lim, A. et al. An Outpatient Management Strategy Using a Coronataxi Digital Early Warning System Reduces Coronavirus Disease 2019 Mortality Open forum infectious diseases (2022) 9(4), ofac063 DOI: 10.1093/ofid/ofac063
AI detects patients at highest risk of COVID-19 mortality
Peer-reviewed research published in Nature Scientific Reports
Atos and Huma support Symbiosis Hospital to expand care capacity
Huma’s ‘hospital at home’ technology will expand care capacity in Pune, India by up to 60%
Breaking the bias in cardiovascular disease
How digital-first care and research can address the gender bias in cardiovascular disease
Decentralized trial sees increased adherence to heart medication
A study testing if a cardiac trial could be run entirely remotely found rapid recruitment, high engagement and that patients with low baseline increased their medication adherence from 85% to 96%.
Digital support against Covid-19 in Germany
Press release: German states focus on patient care via app
Driving Patient Safety with Digital Technology
Patient safety may be paramount across healthcare, but we are a long way from ‘first, do no harm’. The World Health Organisation (WHO) reports that medication errors cause US$ 42 billion of global total health expenditure worldwide, 50% of the overall preventable harm in medical care.
FT 1000: Huma named Europe's fastest growing healthcare company
Press release: Huma listed in the Top 25 for all sectors
Fierce biotech webinar
Taking the "clinic" out of clinical trials and healthcare: Bridging research and care with digital tools
Fixing the foundations: building a solid evidence base for digital health
Our Global Clinical Directors Arrash Yassaee and Peter Kirpalani-Collins explain the importance of clinical rigour and evidence generation in digital health and how we’re doing things differently here at Huma.
HSJ Value Awards 2021
Huma has been shortlisted as a finalist for the HSJ Value Awards 2021.
How Huma technology can reduce burnout on virtual wards
Expectations are high when you hold people’s lives in your hands, so it is little wonder that physicians report emotional exhaustion and feeling overextended, plus a feeling of depersonalization.
How can digital solutions empower and support heart failure patients?
We launched a 12-week remote patient monitoring pilot with Cwm Taf and Betsi Cadwaladr University Health Boards
How decentralized and hybrid trials can drive efficiencies beyond the pandemic
Huma’s Nico O'Kuinghttons discusses how we can drive more efficient decentralized and hybrid clinical trials post-pandemic
How our digital CVD risk model can help reduce avoidable deaths
Our research was published in European Heart Journal Digital Health (EHJ-DH)
How to accelerate digital adoption across the UK healthcare system
We have only seen the tip of the iceberg when it comes to digital health. There is so much more that can be achieved with the adoption of remote patient monitoring - but how can we accelerate it?
How to design virtual wards: 5 tips to set you up for success
Our clinical deployment lead, Dr Terry Deeny shares his top tips for designing successful virtual ward programmes based on Huma’s experience supporting the NHS.
How we help tackle cardiac surgical waiting lists
We worked with Royal Brompton and Harefield hospitals to remotely monitor and prioritise deteriorating patients.
Huma Appoints Kaushik Gune as Head of U.S. Healthcare Business to Promote Adoption of Digital Health Solutions
Huma has appointed Kaushik Gune as the company’s new U.S. Head of Healthcare
Huma acquires iPLATO Healthcare to advance digital-first delivery of care
The two companies will combine their expertise to provide remote patient monitoring for NHS patients
Huma and AstraZeneca Partner to Accelerate Innovation for Digital-First Patient Care
Huma acquires AstraZeneca’s digital health platform AMAZE™ and AstraZeneca becomes a shareholder of Huma
Huma and RARE-X partner to accelerate research
Press release: RARE-X’s federated data platform will pair with Huma’s DCT platform to accelerate research
Huma and Tamer bring digital ‘hospital at home’ platform to the Kingdom of Saudi Arabia
Tamer will bring Huma’s ‘hospitals at home’ technology to the Kingdom of Saudi Arabia to tackle diabetes and cardiovascular disease.
Huma announces US expansion
Press release: Experienced industry leaders create founding US Huma team
Huma appoints Shahram Sharif as Chief Business Officer - Medtech to accelerate digital-first use in the medtech industry
Sharif joins Huma to lead business development activities for digital companion app product
Huma calls for safeguarding of scientific collaboration
CEO & Founder Dan Vahdat speaks at World Economic Forum event in Davos.
Huma collaborates with Bayer to advance precision treatment for lung cancer
Medical technology powered using artificial intelligence
Huma finds way to measure breathing rate using entry-level smartphone gyroscopes
Huma researchers have verified a way to measure breathing rate using the gyroscopes in entry-level smartphones.
Huma joins forces with independent healthcare provider to launch virtual ward service for the NHS
Huma and Xyla Elective Care will work together to deliver tech-enabled virtual wards for the NHS
Huma raises $130 million financing to scale its digital health platform for better care and research
Leading names in health and technology fund expansion
Huma wins prestigious Prix Galien USA 2021 award
Huma’s remote patient monitoring technology is awarded ‘pharma’s Nobel Prize’
Huma wins ‘best of the best’ Prix Galien International 2022 award
Huma has won the Prix Galien International 2022 ‘best of the best digital health product’ award for the impact of its remote patient monitoring platform across healthcare and research.
Huma’s collaborative Covid-19 project wins HSJ Value Award
Our teams enabled better patient care and doubled clinical capacity with our hospital at home technology.
Huma’s peer-reviewed research links bedtime with heart health
Our peer-reviewed research explored the link between time of sleep and risk of cardiovascular disease in over 88,000 people
Increasing clinical trial success rates with adaptive technology
Overall, adaptive trials are more efficient, take less time to complete, and need fewer participants. By allowing for pre-planned modifications to a trial’s design after it has begun, adaptive trials make much better use of resources and money.
Keeping patients safe at home with virtual wards
Digital health has an important role to play in reducing patient harm and improving safety. This blog explores some of the key challenges, insights and learnings that enable safer patient care when using digital technology.
Key themes from this year's MedTech Conference 2022
MedTech Conference 2022, in Boston, one of MedTech’s leading annual events, has wrapped up, and we caught up with our Huma MedTech team to get the low down on all the industry buzz from this year's show.
Mediclinic Middle East launches Mediclinic at Home
A new remote care monitoring system for patients suffering from chronic conditions
Microsoft White Paper: Trends Shaping the Future of Clinical Trials
Microsoft explores the future of clinical trials and how decentralization, using tools like Huma’s, could be the key to shaping their future.
NHS Long Term Plan Webinar Series
How digital technology is helping to battle the growing waiting list backlog
Pharma and digital health must join forces for patients
Dan Vahdat, CEO and Founder of Huma, discusses how we are working with pharma partners to improve clinical outcomes through digital health solutions.
Powering COVID-19 virtual wards for better patient outcomes
Researchers have found that COVID-19 mortality rates were up to four times lower and hospital stays decreased by forty percent with Huma’s technology¹.
Remote patient monitoring pilot shortlisted for two prestigious HSJ Awards
The project has been nominated in the ‘Digitising Patient Care’ category at the HSJ Awards and ‘Virtual or Remote Care Initiative of the Year’ category at the HSJ Patient Safety Awards.
Smith+Nephew partner with Huma
Press release: Smith+Nephew and Huma develop RPM app to assist the restart of UK orthopaedic surgery
Taking the ‘clinic’ out of clinical trials
Bridging research and care with digital tools
Ten highlights from 2021, our 10th anniversary year
How we’re helping ~two million users across our platforms and people around the world live longer, fuller lives
Three ways that digital-first care can improve patient safety
During the COVID-19 pandemic the public were under quarantine orders preventing many patients from seeking care. A study on remote-patient monitoring showed that digital-first care provided a safe and effective option for patients with COVID-19.
Virtual Wards vital to help NHS tackle ‘substantial’ pressures
Huma welcome the Government’s announcement to accelerate the roll out of digital technology to provide an extra 2,500 virtual ward ‘beds’¹.
Webinar: Advancing digital-first delivery of care
Huma and iPLATO (myGP) hosted a joint webinar on how we can bring digital-first care to patients at scale
Webinar: Bridging the digital divide for improved patient diversity
Huma joined leading industry experts for a Reuters Events webinar on fostering diversity in decentralized and hybrid clinical trials
Webinar: Bringing the hospital home via digital virtual wards
Watch our webinar with leaders from the NHS and the AHSH Network.
Webinar: Empowering patients and relieving pressure on the NHS
Learn how Huma’s technology helps clinicians improve outcomes for heart failure patients and identify deteriorating cardiac surgery patients with almost 90% specificity
What Huma has learned from COVID-19
Three important lessons on how COVID-19 is shaping modern medicine
Why we acquired iPLATO (myGP)
Huma & iPLATO (myGP) join to create new possibilities in healthcare and research
World Patient Safety Day: supporting medicine safety with digital tools
For World Patient Safety Day in 2022, our Global Clinical Director Peter Kirpalani-Collins explains how digital healthcare tools can help keep patients safe by monitoring their symptoms and medication use.