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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.
References
- 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
2022: progress and partnership
As 2022 comes to a close, we reflect on the progress we’ve made over the last 12 months in driving a digital-first approach to care and research, enabling people to live longer, fuller lives.
4 Reasons to meet Huma at OCT Europe '23 | 3-4 May, Barcelona
Discover how a digital-first approach to research can drive operational efficiency, accelerate project timelines, and seamlessly improve participant experience.
6 ways remote patient monitoring can help drive MedTech revenue
Remote patient monitoring enables providers to harness the power of real-world data and real-world evidence to increase revenue. Find out how in our latest blog.
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%
Bayer Partners with Huma on Bayer Aspirin Heart Risk Assessment Tool
We’ve partnered with Bayer, a leading global life sciences company, have partnered to develop the Bayer Aspirin Heart Risk Assessment, an online tool that quickly assesses an individual’s risk of developing cardiovascular disease (CVD).
Bayer Partners with Huma on Bayer Aspirin Heart Risk Assessment Tool
Breaking the bias in cardiovascular disease
How digital-first care and research can address the gender bias in cardiovascular disease
Breathe Easier: The Power of Digital Health in Asthma Care and Research
Asthma is a respiratory condition that affects over 300 million people globally. Without treatment, it can lead to life-threatening attacks. Read more to explore how digital health technologies can help patients manage their symptoms effectively.
Come and meet us at DMEA, Berlin!
Looking to attend Europe's top Digital Health event? Join Huma at DMEA from 25-27 April 2023 in Berlin. Don't miss the chance to meet with us and learn about the latest in healthcare technology. Register now!
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%.
Demystifying SaMD Regulation
Many of our customers come to us with questions and even misconceptions about SaMD regulation. Read this article and understand some common myths surrounding SaMDs and how Huma is pioneering a new path forward for companies entering this emerging environment.
Digital health technology offers a way out of the annual winter NHS crisis
As we head towards yet another ‘worst winter on record’, Dr Mert Aral explains how digital health technology can solve the annual NHS crisis.
Digital support against Covid-19 in Germany
Press release: German states focus on patient care via app
Do’s and Don’ts of setting up virtual wards
When it comes to virtual wards, the opportunities for the health sector are immense, but how do you know where to start? We asked industry experts to join us on a panel to discuss some of the do's and don'ts for setting up virtual wards.
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.
Exploring the future of De-centralized and Hybrid Trials: Huma at SCOPE 2023
SCOPE 2023 in Orlando was a summit for clinical ops executives to learn about DCTs. Huma's DCT team shared insights on digital-driven DCTs. Attendees discussed innovative solutions, increasing uptake and appetite for DCTs, and Huma's patient-centric solution.
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.
Growth for good: how Huma is scaling its business to improve patients’ lives
A strong start to 2023: Huma wins Tech Tour Growth50’s Health Award and is named the Financial Times’ fastest growing healthcare company in Europe
HSJ Value Awards 2021
Huma has been shortlisted as a finalist for the HSJ Value Awards 2021.
Health for All: Why Planetary Health is Key to Achieving Global Wellness
To mark its 75th anniversary, the World Health Organisation has made Health for All the focus for this year. This Earth Day, we are looking at how planetary health is an essential component of reaching that goal.
How Digital Health can drive transformation in MedTech
Download our 21-page guide, and discover how senior executives from Huma, Abbott, Smith & Nephew and AliveCor use technology and real-world evidence (RWE) to improve patient outcomes in neurology, cardiology and orthopaedic surgery.
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 Virtual Ward Technology Offers Relief to An Overburdened NHS
Our 21 page guide to Virtual Wards, brings together Huma’s 10 years of experience in implementing remote patient monitoring and virtual wards in the NHS
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 digital-first care is improving health equity
We are at a pivotal time for the healthcare industry. At Huma, we believe that everyone should have an opportunity to attain their highest level of health. Read more about why we believe that digital-first care can promote health equity.
How our Huma app drives engagement in population health research
In a recent study, we teamed up with researchers from the University of Cambridge in a fully remote sub-study of the Fenland longitudinal cohort. Discover what we learned in this blog.
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 + AstraZeneca: pioneering end-to-end digital-first care and research
In March, we announced our pioneering partnership with the world-leading pharmaceutical company, AstraZeneca (AZ) to scale innovation in digital health. Hear from Abby Staible, AZ’s Director of Commercial Digital Health about the impact and what’s to come in 2023.
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 Alcedis, one of the world's leading digital clinical trials companies
Huma announces that it has acquired Alcedis GmbH (“Alcedis”), a market-leader for data driven clinical research and technology.
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 collaborates with Google Cloud to improve healthcare through generative AI
Huma Therapeutics (“Huma”) today announced it will use Google Cloud’s generative AI (GenAI), including Med-PaLM 2, to enhance Huma’s regulated disease management platform.
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 highlights - 2022
2022 was a landmark year for Huma. Take a look back over 2022 and review our key achievements, highlights and partnerships, alongside some of our biggest successes.
Huma joins digital pioneers to advance health equity in care and research
Chief Executive Officer and Founder, Dan Vahdat, is returning to the annual World Economic Forum’s main conference where he will join a panel discussion devoted to improving care for non-communicable disease and tackling health equity.
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 launches digital-first population health programme to identify and manage cardiovascular disease
Huma launches digital-first population health programme to identify and manage cardiovascular disease
Huma forms a new partnership with Camden Health Partners and UCL Partners, supported by a grant from the Small Business Research Initiative (SBRI) Healthcare, to deliver a digital-first programme for those at high risk of cardiovascular disease.
Huma named for its successful and innovative approach to clinical trials in new UK government review
NEW YORK & LONDON, May 25 2023 Huma Therapeutics (“Huma”), a leading global digital health company, is named today as an exemplar of innovation in medical research in an independent review led by former Health Minister, Lord James O’Shaughnessy entitled Commercial clinical trials in the UK.
Huma named for its successful and innovative approach to clinical trials in new UK government review
Huma obtains multi-condition Saudi FDA Class C regulatory certification for its configurable SaMD disease management platform
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 receives multi-condition US FDA 510(k) Class II regulatory clearance for its configurable SaMD disease management platform
NEW YORK & LONDON, June 12, 2023 Huma Therapeutics (“Huma”), a leading global digital health company, today announced that it has received U.S. Food and Drug Administration (FDA) Class II clearance for its disease-agnostic Software as a Medical Device (SaMD) platform.
Huma receives world’s first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform
Huma Therapeutics, a leading global digital health company, today announced that it has become the only company in the world to receive EU MDR 2017/745 Class IIb certification for a disease agnostic Software as a Medical Device (SaMD).
Huma signs partnership with Merck KGaA, Darmstadt, Germany to support cancer care
Huma to attend 41st Annual J.P. Morgan Healthcare Conference
Dan Vahdat, and Chief Financial and Strategy Officer, Ingeborg Oie, will be attending the main conference at the upcoming 41st Annual J.P. Morgan Healthcare Conference.
Huma to provide best-in-class digital clinical trials solutions through landmark acquisition of Alcedis
Huma today announced that it has acquired Alcedis GmbH (“Alcedis”), a market-leader for data driven clinical research and technology.
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 attendance at the BIO International Convention, Boston on June 5th, 2023
Join Huma at the BIO International Convention on June 5th, 2023, where we'll showcase our real-world impact on patient outcomes through partnerships with top pharmaceutical companies. Learn about our innovative solutions in disease management, regulatory approvals and the future of digital health.
Huma's innovative approach to tackling medication adherence
Medication non-adherence poses a significant problem that not only impacts the patient but also the healthcare system. Read this article and discover how Huma’s new medication module can help encourage medication adherence.
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
Hybrid vs decentralized clinical trials: weighing the options for optimal results
If the technology you are using and the team of experts implementing it don’t allow you the flexibility of running either a fully decentralised or a hybrid trial, it is probably not the best solution, furthermore, decentralisation shouldn’t mean that you must spend more money.
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.
Join us for our Ask the Expert session at MedTech Forum, Dublin on 31st May
Are you interested in the latest developments in digital health and their impact on the MedTech sector? Then mark your calendars for the Ask the Expert session at MedTech Forum in Dublin on 31 May.
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.
Largest decentralised study of its kind shows high levels of engagement with Huma’s study app
Huma announces results of the largest population-based study, exploring how digital technologies can support population research.
Mediclinic Middle East launches Mediclinic at Home
A new remote care monitoring system for patients suffering from chronic conditions
Meet Huma at J.P.Morgan
Book a meeting with Chief Executive Officer and Founder, Dan Vahdat, and Chief Financial and Strategy Officer, Ingeborg Oie, in person at the J.P. Morgan annual healthcare conference.
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
Optimizing Medication Management with Digital Platforms
Optimizing patients' medications is key to achieving the best treatment outcomes, but it can be a time-consuming process that requires persistence. Check out this article to learn how Huma's remote patient monitoring platform can boost adherence and improve both outcomes and clinical workflows.
Our digital health platform is now certified as a Class IIb medical device - but what does that actually mean?
Huma has become the first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform. In this article, Rudolf Wagner, Huma's Global Director of Regulatory Affairs, explains what this achievement means for the future of health care.
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.
Preventing Cervical Cancer with Digital Health
Preventing Cervical Cancer with Digital Health
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.
Shifting the dial from reactive to proactive healthcare
We believe digital healthcare tools can transform the proactive healthcare model by offering a more holistic insight into a patient’s health over time. Find out how in this blog written by our Global Clinical Director Dr. Arrash Yassaee.
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
The role of digital technology in clinical trials: key learnings from Outsourcing in clinical trials and Precision in clinical trials
Read Huma's perspective on some key ideas shared at the Outsourcing in Clinical Trials Europe (Barcelona) and Precision in Clinical Trials (Boston) conferences.
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.
UCB and Huma partner to provide digital health solution to improve management of the rare disease, Myasthenia gravis
Read about how Huma and UCB are partnering to provide digital technology that helps patients with the rare disease Myasthenia gravis better understand and manage their condition. This technology will improve education and empowerment, enabling patients to be active participants in their own care.
UCB and Huma partner to provide digital health solution to improve management of the rare disease, Myasthenia gravis
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
Welcome to next-generation digital-first care and research
Discover Huma's cutting-edge platform empowering clinicians with advanced digital capabilities to effectively diagnose, treat, and manage a wider patient population. Explore the reasons behind our breakthrough in delivering these enhanced capabilities.
Welcome to next-generation digital-first care and research
Discover how Huma's innovative technology can transform the healthcare experience for your patients
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