Digital Health: What We Can Learn From Other Countries Experiences

“Twenty percent of Estonians will have used our DNA analysis service by the end of this year and know which diseases they are susceptible to and how they can take appropriate precautions.”

Kersti Kaljulaid, Former President, Estonia – Interview in Der Spiegel
Image Credit: Shutterstock.com

Last week I received a book recommendation based on my previous reading on my Kindle device. The title was: The Year in Tech 2022: The Insights You Need from Harvard Business Review. I immediately purchased and downloaded it. Chapter three caught my eye – Want to See the Future of Digital Health Tools? Look to Germany. The chapter summarizes an online HBR article published the previous year (more on Germany later). And it got me thinking about whether there might be additional lessons to be learned from other countries as well. So, I set off to do some research. It turns out we can learn a lot.


The lead quote for this post, from the former President of Estonia, was a real eye-opener for me from a country we rarely discuss. Imagine a country where citizens will have their genetic profiles integrated into the digital health system with individual risk scores and pharmacogenomic information. When they go to the doctor, they will get fully personalized, genetic risk-based diagnosis, medication, and preventive measures. Estonians are very comfortable using e-services and sharing their data when necessary. Citizens are brought up with the philosophy that they own their data. However, it’s both the public and private sector’s job to use this data in the best way possible—to run their shared services smoothly and improve life in Estonia. Some essential facts:

  • In Estonia, 95% of health data is digitized
  • 99% of prescriptions are Digital
  • 100% of billing is done electronically
  • 94% of citizens are covered by national healthcare

They started to build their digital health system 20 years ago, and within the next few years, the Baltic country will reap the benefits of a transparent, blockchain-based, digital health system hooked on genetic data. The first fully digitized republic certainly sets the direction for other countries to follow. How have they done it? During the last twenty years, project e-Estonia has wired up the entire Baltic nation. The specific services that the government is involved with, legislation, voting, education, justice, banking, taxes, policing, and, naturally, healthcare, have been digitally linked across one platform, X-Road. Citizens can vote through their laptops, sign contracts with their digital signature, or use their chip-IDs when surfing around in the business and land registry – knowing that their data is secured through the blockchain and open to everyone. By having 78.1 percent of public bureaucracy digitized, the country also saves around 2 percent of its gross domestic product. For a deeper dive into the Estonian digital health experience, check out this excellent post from Dr. Bertalan Mesko and his team at The Medical Futurist Institute.


Next, let’s look at Finland, which ranks among the three strongest health technology economies globally. For centuries Finland has been collecting data precisely. And they also have been working for a long time to have their health and social care data digitized and harmonized. Finland has the National Data Exchange Layer, the equivalent of the Estonian X-road (starting to see a pattern here?). The interesting thing about this is that data can be exchanged, even between these two countries. They also have Kanta/My Kanta for Health data. These services are widely used by patients, even though they are relatively new. The system grants access to all healthcare information that the public system has about the person enquiring. People can renew electronic prescriptions, view records related to their treatment, store their living wills and organ donation testament, and consent to or refuse the disclosure of their personal data.


How about Denmark. The world’s third happiest country has one of the most advanced digital health systems alongside an elaborate and concise national digital health strategy for the next four years. The document emphasizes the importance of the cooperation of every healthcare actor through the easiest and fastest way, technology, with a clear purpose: to build an integrated network focusing on patients and looking at the person as a whole, not just at the individual diagnosis. Information on causes of death has been collected since 1875, and cancer incidence has been registered for the whole country since 1943. The Danish National Patient Registry has been keeping records that date 30-40 years back, making it one of the oldest nationwide hospital registries globally.

Another area where Denmark invests heavily is genomics-powered precision medicine – and things are moving fast. The Danish parliament adopted the law to establish the National Genome Center in 2018, and they built up their dedicated supercomputing infrastructure in 2019, began large-scale whole-genome sequencing to build up their accompanying genome database in July of that year. They believe that within the next five years, they will at least do 60,000 whole-genome sequences – at a minimum. Once again, The Medical Futurist Institute gives us a deeper understanding of the situation in Denmark in this post.


The health system in Sweden is founded on the principles of equal access and regional autonomy. Sweden recently updated its national eHealth vision, which now states that, by 2020, all residents aged 16 or over should have access to all health-related information documented in county-funded health and dental care. Two things enable this; a national patient portal and a national health information exchange platform. Although the county councils are autonomous and can prioritize which eHealth services to focus on, the decision was made at a national level that patients should only have one way to reach healthcare. A national patient portal, ‘1177.se’, is available for anyone seeking healthcare or health-related information in Sweden.

Sweden has chosen to implement a national Health Information Exchange (HIE) platform to facilitate the communication between different health information systems and eHealth services. The national HIE platform enables a single point of connectivity for client applications, making all Swedish EHRs appear like a national, virtual EHR. And citizens are responding. Preliminary results of a national patient survey among PAEHR users in Sweden indicate that the overwhelming majority of patients who have accessed the PAEHR are positive about it. Almost 90% of respondents completely agreed, and 8% partly agreed with the statement, “Having access to ‘Journalen’ is good for me.”


Now back to Germany – In late 2019, Germany’s parliament passed the Digital Health Care Act (Digitale-Versorgung-Gesetz, or DVG) — an ambitious law designed to catalyze the digital transformation of the German health care system, which has historically been a laggard in that area among peer countries. The timely introduction of the DVG means that Germany is poised to set an example for other countries in seeing what works (and what does not) in the adoption and diffusion of digital technologies for improving patient outcomes.

Perhaps the DVG’s most important provisions are its formalization of “prescribable applications” (Digitale Gesundheitsanwendungen, or DiGA), which include standard software, SaaS, and mobile as well as browser-based apps, and the creation of the Fast-Track Process, an accelerated regulatory path for companies to take their digital health applications to market. Following a streamlined review, an app can be added to a central registry of apps that can be prescribed by physicians and psychotherapists and will be reimbursed by all of Germany’s statutory health insurance providers, which cover 90% of the population of roughly 73 million individuals. The Fast-Track Process is run by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, or BfArM), which plays many of the same roles in Germany that the FDA does in the United States); BfArM also maintains the DiGA registry. The first five apps have already been added to the registry and offer support for patients to manage conditions including tinnitus, obesity, agoraphobia, osteoarthritis, and insomnia.

DVG promises to provide a standard care environment for manufacturers of new digital health tools to evaluate pricing strategies and understand how digital health applications fit into health care practice and patients’ everyday routines. The importance of such a major country mandating that all insurers have to pay for digital health apps is hard to overstate. With at least 50 apps currently already in the Fast-Track process and hundreds expected over the coming years from manufacturers worldwide, evaluation studies will create a wealth of data on how digital tools for remote patient care work in practice, which other payers and health systems can learn from. They will also be valuable in convincing health care providers — for whom evidence is of paramount importance — of the value of digital tools, both generally and in particular use cases.

Here’s a recently published update on the German DiGA journey with data through November, 2021.


So what can we learn from these examples? – There are several common elements to these national digital health programs that we could benefit from. But, and this is a crucial challenge, we would have to make major structural, payment, regulatory and legislative changes to how we currently operate. Here are my three major observations:

Interoperability is essential – Whether it’s X-Road in Estonia, My Kanta for Health in Finland, the National Patient Registry in Denmark, or 1177.se in Sweden, the data is interoperable and accessible across all sites of care, and in some instances, across country borders. Contrast that with our experience. Ask the question: “What have the American people gotten for their $35 billion HITECH investment?” The answer is not much. Silos abound. Compiling a single, comprehensive patient record is impossible. We have no national patient identifier to prevent mixing patient records. Cybersecurity is dismal at best. All of this is in a country that spends more than 17% of GDP on health care and has an administrative overhead estimated to be over 8%.

Image Credit: OECD, 2019

Patients own their health and genetic data – Most citizens in the countries discussed above are brought up with the idea that they own their data, can control who has access to it and for how long. In those countries that are doing genetic profiles of their citizens, the patient controls the information and its use – in some instances, using blockchain technology to maintain security and authorization of access. Here, the accepted norm is that your provider “owns” your data. And although you can request a copy of your patient records, you’ll likely be charged for the privilege and will either receive the information in paper form on a disk that is of little use. While patient data advocates like Dave deBronkart Jr, widely known as e-Patient Dave, a cancer patient, and blogger who, in 2009, became a noted activist for healthcare transformation through participatory medicine and personal health data rights, and others push for this, progress is slow.

“Owning a copy of your personal data does not change property law, medical record requirements, or hinder the advancement of science. But it does build health equity by giving everyone equal access to their lifetime medical data.”

Juhan Sonin, Annie Lakey Becker and Kim Nipp, Stat First Opinion, November 15, 2021

Data ownership gives each of us the keys to our health puzzle and insight into how our data is used outside medical appointments to further research, innovation, and better health care for all. It gives us the keys we need to care for ourselves and our loved ones, and to build health in our communities and our country at large. Data ownership unlocks the path to achieving our health and wellness potential.

Including an individual’s genetic information is critical to personalized care. – In addition to Estonia, the NHS in the UK, Iceland, and the UAE have plans to sequence the DNA of large segments of the population to make citizens’ lives better. Here in the U.S., Boston Children’s Hospital had a five-year program where parents of newborns had the option of having the child’s DNA sequenced to test whether that information helps guide the care of babies and monitor how pediatricians and parents react to knowing it. Phase 1 of that study wrapped up in 2019. These plans likely won’t be perfect at first. But other nations looking to implement their systems might build off those, and citizens will be the ones to benefit.

Digital health tools development is a complex, multifaceted, and highly dynamic environment. While significant implementation challenges remain, I’m confident that there is a better chance of preparing for whatever is coming next by demonstrating the best practices of how other governments, regulators, and developers tackle the challenges of today.

Health Tech News This Week – November 27, 2021

What happened in health care technology this week – and why it’s important.

Image Credit: Shutterstock.com

A new, gel-based wearable can catch infections before the naked eye can

A team of researchers had designed a wearable sensor that, in preliminary testing, identified infections in open wounds before they looked any different than uninfected wounds. Maddie Bender reported on their progress in an article in Stat Health. Their sensor, which combines principles from biology, materials science, and electrical engineering, may one day be a low-cost, time-saving alternative to existing diagnostic tools.

The device senses infection at its source by exploiting a particular quirk of harmful bacteria. For reasons that are not entirely understood, many strains of harmful bacteria secrete an enzyme called deoxyribonuclease. It’s a reaction with that enzyme that the new wearable sensor ultimately converts into a signal.

Why it’s important – The hope is that detecting infections more quickly will lead to treatment that can uproot an infection before it progresses to a complicated and potentially life-threatening illness. The study, published in the journal Science Advances, comes on the heels of an October study by an overlapping group of collaborators that focused on using sensors to monitor a range of biometrics in surgical wounds. The new research centers exclusively on bacterial infection, a wound complication that costs health care systems billions of dollars and frequently leads to death.


Coming Soon: A Wearable Device to Predict Epileptic Seizures

Dennis Thompson posted an article in Health Day News outlining why investigators now think they’re on the path to accurately predict epileptic seizures by using a wristband device that tracks different body signals. The researchers identified patterns among patients that could allow about a half-hour of warning before a seizure occurs, according to findings published online recently in the journal Scientific Reports. Participants were asked to wear the device for six months to a year and upload data every day to cloud storage. The algorithm took a look at each individual patient and tried to figure out the specific “tells” that would predict when they would be at the highest risk for a seizure.

Why it’s important – Previous studies of epilepsy have determined that seizure forecasting is possible based on data gained from brain implants placed in people’s heads to help control seizures. However, until now, there’s been no non-invasive way to gather the sort of data that might allow such a prediction to occur. Just knowing that the epileptic “storm” is coming could be a huge benefit to patients with poorly controlled epilepsy. People also would benefit from knowing that there’s no seizure risk in the near future. The technology is available today, but the algorithm reliably predicts epileptic seizures is still years away.


“The Designer Baby Project” Imitates a Gene Editing Company That Specializes in Designer Babies

I just genetically designed a baby. And the experience was as creepy as it sounds. The Designer Baby Project is an exploratory endeavor by science journalist and writer Torill Kornfeldt and web developer Julia Johansson of the visualization studio Order Order. This is a website meant to imitate a gene-editing company that specializes in babies. It lets you try what it could be like to order a baby with technology likely to be available soon.

Image Credit: The Designer Baby Project website – Accessed 11/23/2021

When Torill was working on her second book, The Unnatural Selection of Our Species, she performed numerous interviews and research trips worldwide to find out more about genetic editing in humans. In the beginning, she had a hypothesis that science was advanced but not within practical reach for decades. After one particular trip, she and Julia met for a cup of tea, and Torill explained both horrified and excited that the first genetically modified babies had already been born. This and further development raised severe ethical issues. Why is no one talking about this? We need to talk about it! They then decided to take this knowledge and place it in the concrete format of a website where you can go through the process of customizing a baby.

Why it’s important – The whole experience was something everyone should go through when thinking about the ethical side of using technologies like #CRISPR for this purpose. All of the choices are probable and around the corner soon to be accessible. As with many new and shiny things, access is likely to be for only the very rich in the beginning. Even so, the entire field opens up questions such as “Who should be able to decide?” and “What should you be able to modify.” When the opportunities exist, a passive choice will also be a choice. If nothing else, the project will spur debate on some of the critical issues society will need to face in the near future.


RSNA 2021 – What to Expect From the World’s Largest Medical Imaging Conference

“After two challenging years, our attendees were ready to return to Chicago for the world’s leading imaging forum and to engage with the state-of-the-art technical exhibition.”

Mary Mahoney M.D., President, Radiological Society of North America
Image Credit: Radiological Society of North America

It’s Thanksgiving week. And medical imaging professionals know that generally means a terrific dinner with family, a short day of relaxation following all that food, and a Saturday trip to the Windy City to prepare for the opening of the world’s biggest medical imaging conference, the Annual Meeting and Exhibition of the Radiological Society of North America (RSNA).

In the past, that was my usual Thanksgiving routine throughout my time as a company representative and provider of imaging services. In all, I’ve attended 43 RSNA conferences. And it’s was both a grueling and fun experience. I know I don’t have the stamina today to handle a week of booth duty, customer meetings, presentations, and walking the halls of McCormick Place (for miles and miles) to scope out the competitive landscape. But, that doesn’t mean I’m not interested in what technology will be shown and what techniques will be discussed. So, I thought I’d dust off my crystal ball and take a shot at forecasting what this year’s conference will be like – for attendees and exhibitors. Here goes:

Attendance will be down considerably from pre-COVID-19 levels – An industry reporter acquaintance emailed me this week saying that his contacts told him that Professional registration is now at 9,200. This is approx. 50% of in-person professional registration from the same time in 2019. 31% of the professional, in-person registrants are from outside of N. America. This ratio is similar to 2019. There are 7,800 virtual RSNA meeting registrants, 56% of which have opted for both the in-person and virtual event (we’ll have to watch out for double-counting in the reported numbers), so they can access the RSNA educational program until April 30th, 2022. On Monday of this week, Aunt Minnie published an article that stated that the Society is expecting about 19,000 in-person attendees and about 4,000 virtual attendees. Pre-pandemic attendance was usually between 51,000 and 60,000 total attendees.

Exhibitor numbers and total exhibitor square footage is down – The number of exhibitors is down approximately 33% vs. 2019, with 495 in-person technical exhibits occupying 296,000 square feet (versus 740 technical exhibits occupying 452,000 square feet in 2019). I would expect that companies will send fewer staff to the conference this year. Some exhibitors have opted only to do virtual booths. Most major exhibitors will have a robust online component to their marketing efforts for 2021 – mirroring what they did last year – 52 virtual exhibits, including 32 virtual-only exhibits. (Numbers accurate as of 10/30/2021)

A.I. will be a significant focus again this year – As usual, AI research will be the focus of a variety of dedicated scientific sessions, as well as sprinkled throughout the scientific program at RSNA 2021. AI is increasingly being investigated for its potential utility in predicting patient outcomes and guiding treatment. The conference will also include an A.I. Showcase which will be located in the South Hall of McCormick Place this year. As of early November, 93 vendors were scheduled to showcase their wares in this dedicated area on the exhibit floor. Those visiting the AI Showcase in person will also have the opportunity to visit the RSNA’s Imaging AI in Practice interactive exhibit, which will feature 22 vendors demonstrating AI technologies and the integration standards needed to embed AI into the diagnostic radiology workflow. Featuring 32 different products, the interactive exhibit will showcase the use of AI and health IT standards throughout the radiology workflow in real-world scenarios.

Photon-Counting CT will be the talk of the exhibition – Just this past week, Siemens Healthineers’ Shape 22 pre-RSNA event featured an ambitious hardware announcement that stands to expand what can be done with CT exams. The new scanner has received clearance from the U.S. Food and Drug Administration (FDA), a move the FDA said was the “first major imaging device advancement” in CT in nearly a decade. Naeotom Alpha uses the emerging technology of photon-counting CT, in which each individual x-ray photon is measured as it passes through the patient’s body. This differs from existing CT instrumentation, in which the scanner’s detectors measure the total energy in many x-rays at once. Proponents of photon-counting CT believe the scanners can give radiologists much more detailed images at a lower radiation dose than conventional CT. Photon-counting images have a higher contrast-to-noise ratio, resulting in higher resolution and the correction of artifacts like beam hardening. Siemens claims that photon-counting CT will be the standard within ten years. So, that creates a fascinating thing to watch at this year’s RSNA. What’s the response from Siemens’ competitors like GE, Philips, and Canon? We are probably in for a treat listening to the marketing gurus spin their company messages. GE in 2020 made a major investment in the future of photon-counting CT by acquiring Prismatic Sensors, a Stockholm-based developer of the technology using silicon. But is “Deep Silicon design” enough to blunt the splash Siemens has made? Inquiring minds want to know…..

Mobile imaging solutions featured prominently – As I outlined in a previous post, the options for bringing medical imaging to the point of care have grown with the introduction of portable CT, MRI Ultrasound, and next-generation digital x-ray systems. Hyperfine will be exhibiting its Swoop mobile MRI system. Samsung and Siemens will be showing their portable CT systems. Butterfly, GE, Philips, and others will be highlighting their handheld ultrasound systems. And multiple vendors will be showing redesigned mobile digital x-ray systems. The COVID-19 pandemic and the Hospital@Home movement have prompted health systems to rethink their approach to point-of-care imaging. And, many are adding capabilities to their fleet of services to meet the expected demand.

My most anticipated RSNA reporting – Every year, I look forward to reading Michael Cannavo’s PACSman Awards article on AuntMinnie.com. Michael J. Cannavo is known industry-wide as the PACSman. After several decades as an independent PACS consultant, he worked as a strategic accounts manager and solutions architect with two major PACS vendors. He has now made it back safely from the dark side and is sharing his observations. I had the opportunity to work with Michael during my tenure at Philips Healthcare. And I love his irreverent but highly accurate look at the world of the RSNA technical exhibition. If you haven’t experienced Michael’s annual post, here’s a link to his 2020 RSNA PACSman Awards.

Wild cards – Lots of pre-RSNA online postings (primarily Twitter, Facebook, and Press Releases) from one company about a new system with a “novel x-ray source” that’s going to “revolutionize” digital radiography. (Hint to the vendor: using the term “cold cathode” in your marketing materials doesn’t mean there isn’t heat generated in creating x-rays. Electrons smash into the target/anode, and only less than 1% of the energy is converted into usable x-rays, while the rest gets wasted as heat. Isn’t it wonderful that the laws of physics apply to everyone?) As to the term “novel” x-ray source, perhaps the vendor in question should look at the portable x-ray machine from Carestream, which uses a carbon nanotube, cold-cathode x-ray source. Or, maybe a review of what Fuji and Micro-x are doing would be in order. I’ll reserve the final judgment on this vendor until after the conference. But perhaps I’ll nominate them for one of Mr. Cannavo’s PACSman awards this year.

So, how much of this will I get right? We’ll know after next week is over. I’ll be posting my highlights of the 2021 RSNA in early December. They might not be as entertaining as the annual PACSman Awards, but they’ll include what was discussed and why I think it’s important. Thanks for reading! My sincere best wishes to you and your families for a happy and safe Thanksgiving gathering.

Health Tech News This Week – November 20, 2021

What happened in health care technology this week – and why it’s important.

Image Credit: Shutterstock.com

UK firm to trial T-cell Covid vaccine that could give longer immunity

An Oxfordshire-based company will soon start clinical trials of a second-generation vaccine against Covid-19. This easy-to-administer skin patch uses T-cells to kill infected cells and could offer longer-lasting immunity than current vaccines. As reported by Julia Kollewe in The Guardian, Emergex has received the green light from the Swiss drugs regulator to conduct initial human trials in Lausanne, involving 26 people who will receive a high and a low dose of its experimental Covid-19 vaccine, starting on 3 January. Interim results from the trial are expected in June.

Why it’s important – A study published in Nature last week showed that some people experience “abortive infection” in which the virus enters the body but is cleared by the immune system’s T-cells at the earliest stage. Scientists said the discovery could pave the way for a new generation of vaccines targeting the T-cell response, producing much longer-lasting immunity. And the technology has broader applications than just COVID-19. Emergex is testing another T-cell vaccine against dengue fever on humans in a separate Swiss trial, with initial results due in January.


Hilton is Amazon Care’s newest client

Amazon Care will be providing health services to Hilton as its second publicly announced customer. As reported by Reuters, all of Hilton’s staff in the United States who are enrolled in a corporate health plan will have access to Amazon’s app-based medical options starting next year. The deal with Hilton Worldwide Holdings Inc, which Reuters is the first to report, marks Amazon Care’s first hospitality customer and only its second disclosed client after fitness equipment maker Precor.

Why it’s important – It shows how the company is seeking to disrupt the healthcare industry with a tried-and-true playbook. Just as Amazon built data centers to satisfy its e-commerce needs and later sold access to this infrastructure in what became its cloud-computing business, so is Amazon looking to market a healthcare service it built first for its workers’ benefit. So, don’t write off Amazon as a major player in health care services just yet.


FDA clears GE Healthcare AI algorithm for patient intubation

An artificial intelligence algorithm developed by GE Healthcare that helps with the placement of endotracheal tubes (ETTs) has been approved by the FDA. As reported in Pharmaforum online, the new tool – part of GE’s Critical Care Suite 2.0 – helps bedside staff and radiologists assess patients before intubation – for example, before ventilation in patients with critical COVID-19 – and make sure their ETTs are positioned correctly.

Why it’s important – Anyone who has intubated a patient or at least witnessed the intubation process knows how tricky it can be even in the hands of an experienced medical professional. Using the AI, ETTs are automatically identified in chest X-ray images, providing feedback to the clinician on positioning within seconds and warning them if it hasn’t been placed correctly. It will also quickly detect complications like pneumothorax and can automatically send an alert to a radiologist along with the X-ray images for review.


Smartphone-powered trial backs J&J’s Invokana for heart failure

In what is being labeled as one of the first “virtual clinical trials,” Pharmaforum online reports that Johnson & Johnson’s SGLT2 inhibitor Invokana has been shown to have a significant effect on heart failure symptoms in a clinical trial that relied entirely on remote monitoring of symptoms using a smartphone app.

“We did not know if a completely ‘virtual’ clinical trial, especially one where randomised treatment was delivered to participants and the outcomes were collected through a smartphone app, could work.”

John Spertus, Lead University of Missouri-Kansas City School of Medicine

Why it’s important – Demonstrating the success of a decentralized clinical trial opens opportunities for applying this approach to the testing of other cardiovascular therapies that focus on health status. This study also proves that virtual clinical trials can be effectively used across a broad spectrum of life sciences developments.


VR treatment for chronic pain gets FDA authorization

Nicole Wetsman’s article in The Verge highlights the FDA clearance of a virtual reality system as a prescription treatment for chronic back pain. The therapy, called EaseVRx, joins the shortlist of digital therapeutics cleared by the agency over the past few years. EaseVRx includes a VR headset and a device that amplifies the sound of the user’s breath to assist in breathing exercises. It uses principles from cognitive behavior therapy, which aims to help people recognize and understand various thought patterns and emotions. The program addresses pain through relaxation, distraction, and improved awareness of internal signals, the FDA said in its statement.

Why it’s important – Around two-thirds of participants using EaseVRx said they had more than 30 percent reduction in pain, while only 41 percent of the control group had a similar decline. The reduced pain lasted for up to three months after the study for people in the EaseVRx group but not for the control group. The VR system could be an alternative option to opioid medications for back pain. For a deeper dive into the use of extended reality in health care, check out my earlier post on the topic here.


CMS proposes expanded payment for CT lung cancer screening

Kate Madden Yee reported on the news that the U.S. Centers for Medicare and Medicaid Services (CMS) on November 17 released a proposed update to its low-dose CT lung cancer screening guideline that would start paying for exams beginning at age 50 five years younger than under its current policy. The move would bring Medicare and Medicaid reimbursement in line with recommendations from the U.S. Preventive Services Task Force (USPSTF), which itself lowered its recommended starting age for screening earlier this year.

Why it’s important – The action is an acknowledgment of the severity of lung cancer and its high mortality rates if it is not caught and treated early — which is of particular importance in the older Medicare population. “Lung cancer is the third most common cancer and the leading cause of cancer-related death in both men and women in the United States,” the agency wrote. “It is an important issue for the Medicare population due to the age at diagnosis and the age at death. In 2021, the National Cancer Institute (NCI) estimated that the number of new cases is over 235,000, with a median age at diagnosis of 71 years.” Like the USPSTF guidance released in March, the proposed guidance from CMS lowers the starting age for screening from age 55 to age 50 and the smoking history from 30 pack years to 20.


First human trial of Alzheimer’s disease nasal vaccine to begin at Boston hospital

Brigham and Women’s Hospital will test the safety and efficacy of a nasal vaccine to prevent and slow Alzheimer’s disease, the Boston hospital announced Tuesday. The start of the small, Phase I clinical trial comes after nearly 20 years of research led by Howard L. Weiner, MD, co-director of the Ann Romney Center for Neurologic Diseases at the hospital. The trial will include 16 participants between the ages of 60 and 85, all with early symptomatic Alzheimer’s but otherwise generally healthy. They will receive two doses of the vaccine one week apart, the hospital said in a press release. The participants will enroll at the Ann Romney Center.

Why it’s important – If clinical trials in humans show that the vaccine is safe and effective, this could represent a nontoxic treatment for people with Alzheimer’s. It could also be given early to help prevent Alzheimer’s in people at risk. Research in this area has paved the way for researchers to pursue a whole new avenue for potentially treating AD and other neurodegenerative diseases.

Health Tech News This Week – November 13, 2021

What happened in health care technology this week – and why it’s important.

Image Credit: Shutterstock.com

Electrochemical Test Measures Antibiotic Resistance

Medgadget writer Conn Hastings reported on work from researchers at Washington State University who have developed an electrochemical test that can rapidly identify antibiotic-resistant bacteria in patient samples. The technology can provide a result in less than 90 minutes and is based on measuring the bacteria’s electrochemical activity after they are exposed to antibiotics. The data reveal the metabolism and respiration of the bacteria. If they are still happily metabolizing after exposure to an antibiotic, they are considered resistant to it. By providing a rapid answer to the question of antibiotic resistance, the method could be beneficial for clinicians in prescribing the most appropriate antibiotic for their patients.

Why it’s important – In the age of antibiotic-resistant bacteria, prescribing the correct antibiotic is becoming critical. If a clinician gets it wrong, the treatment won’t work, and misused antibiotics could even contribute to new resistant forms of bacteria. Instead of looking for the growth of a culture, they look for metabolism, and that is basically what they’re detecting by the movement of these electrons so that it can happen in much shorter time spans compared to a conventional culture-based assay.


Scientists discover an antibody that can protect people against several coronaviruses

An article in Rifnote online by Mansur Shaheen describes research at the University of North Carolina – Chapel Hill (UNC) and Duke University, in Durham, where scientists have identified an antibody that can protect people from COVID-19, its variants, and other types of coronaviruses. The antibody, DH1047, works by binding to the virus’s cells and neutralizing them, preventing them from replicating.

Why it’s important – This antibody has the potential to be a therapeutic for the current epidemic. It could also be available for future outbreaks, if or when other coronaviruses jump from their natural animal hosts to humans. The findings provide a template for the rational design of universal vaccine strategies that are variant-proof and provide broad protection from known and emerging coronaviruses.


Google is taking sign-ups for Relate, a voice assistant that recognizes impaired speech

As reported in The Verge, Google launched a beta app that people with speech impairments can use as a voice assistant while contributing to a multiyear research effort to improve Google’s speech recognition. The goal is to make Google Assistant, as well as other features that use speech to text and speech to speech, more inclusive of users with neurological conditions that affect their speech.

The new app is called Project Relate, and volunteers can sign up at g.co/ProjectRelate. To be eligible to participate, volunteers need to be 18 or older and “have difficulty being understood by others.” They’ll also need a Google account and an Android phone using OS 8 or later. For now, it’s only available to English speakers in the US, Canada, Australia, and New Zealand. They’ll be tasked with recording 500 phrases, which should take between 30 to 90 minutes to record. Here’s a short video showcasing the project:

YouTube Project Relate video credit: Google

Why it’s important – Other Google apps like Translate and Assistant haven’t been very accessible for people with conditions like ALS, traumatic brain injury (TBI), or Parkinson’s disease. The hope is that the Project Relate data will help people with speech impairments when having conversations or when using voice commands for home assistant devices.


Nvidia unveils new healthcare offerings at GTC Fall 2021

Graphics processing unit technology developer Nvidia introduced a new healthcare artificial intelligence (AI) computing platform, as well as a new relationship with MD Anderson Cancer Center, at this week’s GPU Technology Conference (GTC) Fall 2021. Eric Ridley reported on these topics in his article on AuntMinnie.com. Clara Holoscan is designed to provide the computational infrastructure to enable medical device developers to build applications that process multimodality sensor data, run physics-based models, accelerate AI inferencing, and render high-quality graphics in real-time, according to the vendor. It provides scalable, end-to-end processing of streaming data for medical devices.

Nvidia is now also partnering with MD Anderson Cancer Center on cancer-focused AI initiatives. Several radiology AI initiatives are underway, including new AI models aimed at early detection of pancreatic cancer — a leading cause of cancer deaths that’s often identified only after it has metastasized. Other AI initiatives underway at MD Anderson include image-contouring models for planning of radiotherapy treatments and MRI-assisted radiosurgery, as well as an algorithm that analyzes post-treatment prostate MRI studies to assess the quality of radiation delivery.

Why it’s important – As I highlighted in a previous post, Nvidia continues to grow its footprint in health care through partnerships like the one with M.D. Anderson Cancer Center. They’re leveraging their strengths in AI and machine learning to create a robust platform for researchers to increase the variability of their sample datasets, which in turn boosts the model’s accuracy and generalizability.

Health Tech News This Week – November 6, 2021

What happened in health care technology this week, and why it’s important.

Image Credit: Shutterstock.com

FDA releases ‘guiding principles’ for AI/ML device development

The U.S. Food and Drug Administration released a list of “guiding principles” this week aimed at helping promote the safe and effective development of medical devices that use artificial intelligence and machine learning. As reported by Kat Jercich in HealthcareIT News, the ten guiding principles identify points at which international standards organizations and other collaborative bodies, including the International Medical Device Regulators Forum, could work to advance Good Machine Learning Practices (GMLP).

Why it’s important – The agency says stakeholders can use the principles to tailor and adopt good practices from other sectors to be used in the health tech sector, as well as to create new specific methods. Having these baseline ten principles will help to inform regulatory practices in the future.


User-Centered Design of Companion Robot Pets Involving Care Home Resident-Robot Interactions and Focus Groups With Residents, Staff, and Family: Qualitative Study

Companion robots, such as Paro, demonstrate strong potential for helping reduce this pressure through reported benefits, including reduced agitation, depression, loneliness, care provider burden, and medication use. But there have been few studies undertaken to look at the design of these robots. A recent study published in JMIR aimed to provide user-centered insights into the design of robot pets from critical stakeholders to inform future robot development and the choice of robots for real-world implementation and research.

They found that care home residents, family members, and staff were open and accepting of the use of companion robot pets, with the majority suggesting that they would keep a device for themselves or the residents. The most preferred device was the Joy for All cat, followed by the Joy for All dog. In discussions, the preferred design features included familiar animal embodiment (domestic pet), soft fur, interactivity, big appealing eyes, simulated breathing, and movements. Unfamiliar devices were more often seen as toy-like and suitable for children, producing some negative responses.

Image Credit: Ageless Innovation LLC

Why it’s important – This is the first study to focus on the end-user and their caregivers’ insights into which design elements will support the adoption and regular use of companion robots. The results have implications for future robot designs and the selection of robot pets for both research and real-world implementations.


The unexpected health impacts of wearable tech

We didn’t realize how much doctors would see of our health data and whether or not the information would help treat and manage chronic conditions. But, as Nicole Wetsman reports in The Verge, people were using the devices to monitor their health — tracking their heart rate, steps, and sleep. And gradually, more and more of them started to bring that information along to their doctors’ appointments. The permeation through healthcare is particularly noticeable in three areas: cardiology, sleep medicine, and sports medicine.

Kardia Mobile 6L Image Credit: AliveCor, Inc.

Why it’s important – The increase in the use of patient-generated health data (PGHD) has been hotly debated in health care circles for several years now. Depending upon the clinical use case, and as has been described in the article, patients and their care teams can benefit from the real-time monitoring and reporting of data. This accomplishes three things. First, it tells the provider more about chronic disease self-management in everyday life. Second, it holds the patient accountable for that self-management. And finally, it can notify a clinician when a patient’s disease state becomes out of control and spur intervention. PGHD use is still limited, but the data suggest that when patients collect and providers view PGHD, it can positively impact patient health.


A smart knee implant promises to ‘help write the future of orthopedic technology.’ Surgeons aren’t so sure

Mario Aguilar, Health Tech Correspondent at STAT, reviews a new, souped-up knee implant developed by Zimmer Biomet as a way to passively collect data about recovery after one of medicine’s priciest and most common procedures. The implant — cleared by the Food and Drug Administration in August for use in a small subset of knee replacements — contains sensors, a wireless transmitter, and a pacemaker-like battery that could paint a far more precise picture of the recovery process problems that arise. The company has called it “groundbreaking” and claims it will “help write the future of orthopedic technology.” But the surgeons who will need to embrace the implant caution that while the device has potential, insights are likely far off — if the data turns out to be helpful at all.

“Technology has to be proven that it’s going to improve outcomes in order to be used. So, you know, even though this sounds like a cool idea … this isn’t going to improve our outcomes.”

Calin Moucha, Chief Joint Replacement Surgeon, Mount Sinai Health System, NY

Why it’s important – The quote above says it all. In joint replacement, novel technology usually isn’t favored over established implants with years of positive results. Some surgeons agree that such information might one day help identify patients whose implants had loosened or who required attention that couldn’t be detected with routine X-rays or changes in symptoms. But surgeons still have concerns about the utility of the data Zimmer Biomet is collecting as it goes to market with the technology. Most agree that mobility data is “interesting from a biomedical science standpoint and understanding the function of these implants,” but are adamant that it’s no substitute for hearing from a patient.


FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions

More news from the FDA this week. The FDA is making available the draft guidance Content of Premarket Submissions for Device Software Functions intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software functions. The proposed recommendations in this draft guidance document pertain to device software functions, including both software in a medical device (SiMD) and software as a medical device (SaMD), and describe a subset of information that would be typically generated and documented during software design, development, verification, and validation.

“As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into medical devices. The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions that is aligned with current standards and best practices.”

Bakul Patel, Director, FDA Digital Health Center of Excellence in the Center for Devices and Radiological Health

Why it’s important – For software developers, this guidance will eliminate any confusion in the submission process and represents a step forward in the regulation of medical software products. The FDA is requesting comments on the draft now. When final, this guidance will replace the FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005. It will update the FDA’s recommendations on the appropriate documentation for the review of device software functions in premarket submissions.


Alphabet has a new drug discovery company building on DeepMind’s AI chops

Katie Palmer in Stat+ (subscription required) reported on the launch of Isomorphic Laboratories. This new Alphabet company aims to leapfrog the success of the protein-folding work to apply deep learning methods to drug discovery. Isomorphic will focus on building predictive or generative models of biological phenomena, using computers to anticipate how drugs will perform and potentially design novel molecules. Rather than developing its own pipeline of drug candidates, the company may aim to sell its models platform as a service.

Why it’s important – DeepMind can leverage the success of its protein folding work in predicting protein structure with its deep learning model, AlphaFold2. The new company could focus upon protein-protein interactions, small molecule design, binding affinity, and toxicity analysis as potential targets for predictive models. Isomorphic’s most immediate task will be in staffing up a multidisciplinary group of deep learning experts, computational biologists, medicinal chemists, biophysicists, and engineers.

Some Straight Talk on Edge Computing in Health Care

“5G and edge computing will enable the low-latency, real-time guaranteed conditions necessary to use IoT devices for patient monitoring and at-home care. For rural patients unable to access the care provided in larger metropolitan facilities, this could be a game-changer.”

Greg Chiasson, Principal, Capital Projects & Infrastructure (Technology, Media and Telecommunications), PwC US
Image Credit: Shutterstock.com

Centralization has been a predominant paradigm in healthcare computing for the past several decades. Originally, this meant that provider organizations operated large, centralized data centers that housed mainframes and servers designed to serve as the industry’s computing workhorses. Recent technological advancements are starting to shift that paradigm, however.

Edge computing, through on-site sensors and devices, as well as last-mile edge equipment that connects to those devices, allows data processing and analysis to happen close to the digital interaction. Rather than using centralized cloud or on-premises infrastructure, these distributed tools at the edge offer the same quality of data processing but without latency issues or massive bandwidth use. It seems clear that edge computing will play an essential role in health care. But what is it? And why is it a significant development?

First, some basics – Edge computing is the practice of capturing, storing, processing, and analyzing data near the client, where the data is generated, instead of in a centralized data-processing warehouse. Hence, the data is stored at intermediate points at the ‘edge’ of the network, rather than always at the central server or data center.” The concept dates back to the 1990s when Akamai solved the challenge of Web traffic congestion by introducing Content Delivery Network (CDN) solutions. The technology involved network nodes storing static cached media information at locations closer to end-users. Today, edge computing takes this concept further, introducing computational capabilities into nodes at the network edge to process information and deliver services.

How is edge computing related to cloud computing? – Think of edge as an extension of the cloud rather than a replacement. Cloud computing is the concept of storing, processing, and analyzing large amounts of data on remote servers or “data centers,” usually online. Data centers are often located remotely where data is processed and collected, resulting in a period between collection and processing or “high delays.” While the lag of time is usually only a few hundred milliseconds, it makes a massive difference to time-sensitive applications. In addition, a large amount of data moving up and down the network poses significant difficulties to bandwidth. This can reduce the speed of data processing and transfer. This back-to-back period could mean the difference between life and death in time-sensitive applications, especially in health care. So, edge computing is used to process time-sensitive data, while cloud computing is used to process data that is not time-driven.

Why is edge computing important for health care? – In the healthcare industry, data is growing at an astounding rate. A recent Dell Technologies global survey found that healthcare and life sciences data had grown by 878 percent over the previous two years — with no slowdown in sight. A significant percentage of this data is coming from the 10–15 connected devices that are often found at the typical hospital bedside. At the same time, healthcare providers are also collecting a mountain of patient data generated from connected wearable medical devices, like smartwatches and mobile wellness applications. Whether it’s on a health worker’s tablet, a wearable device, an ingestible sensor, or a mobile app, computing at the “edge” of the network is essential for speed, scale, and performance. The challenge now is putting all of this data to work to improve diagnostic and patient care processes to contribute to better patient outcomes.

What are some key use cases for edge computing in health care? – In connected healthcare, distributed analytics unlocks insights from data collected from IoT devices to help healthcare providers see beyond episodic patient visits. Edge computing broadens the field of vision, creating a continuous real-time patient record that helps providers shift from reactive to proactive care. A clear view of the power of Edge computing emerges in use case examples that illustrate how the healthcare equation changes when the analytics are brought to the data, including:

Rural medicine – Providing quality healthcare to isolated rural areas has been a challenge throughout history. Even today, with innovations in telemedicine and more readily accessible health data, medical providers have struggled to deliver fast, quality care to people who live far from hospitals and have limited internet access. Traditional healthcare databases face significant challenges here due to connectivity issues, but combining IoT medical devices and edge computing applications can make it easier to overcome these difficulties.

Patient-Generated Health Data – A range of IoT medical devices such as wearable sensors, blood glucose monitors, and healthcare apps have become far more common over the last decade, all of them collecting massive amounts of Patient-Generated Health Data (PGHD) that makes it possible for medical professionals to diagnose problems better and monitor patient health over long periods. The enormous amount of data produced by these IoT edge devices may be valuable. Still, it’s also creating a challenge for the healthcare providers tasked with managing it and keeping it secure. Edge computing applications have the potential to solve this data problem. By retaining much of the critical processing tasks on the devices located on the edge of the network, healthcare IT architectures can still benefit from gathering health-related data while also getting the rapid, real-time analytics that can predict and respond to health emergencies.

Improving the patient experience – Going to the hospital doesn’t have to be an unpleasant or frustrating experience. From smart devices that allow people to check-in for appointments whenever they like to notifications that guide them through an unfamiliar facility to find the appropriate office, IoT medical devices are among the key edge computing use cases that can potentially transform the healthcare industry’s customer experience completely.

Improving the supply chainSensor-equipped IoT edge devices have the potential to revolutionize the way medical facilities manage their inventories. Devices gathering data on usage patterns can utilize predictive analytics to determine when the hardware will likely fail. Inventory management based on intelligent RFID tags can eliminate time-consuming paperwork and manual ordering. Fleet vehicles equipped with GPS and other sensors can track the location of critical shipments in real-time. For organizations struggling to control rising costs, IoT healthcare supply chain innovations offer an opportunity to gain operational efficiencies on the margins and represent one of the more compelling edge computing use cases.

Improved patient safety and monitoringComputer vision solutions can monitor acute patient safety and longer-term medical compliance to reduce readmissions. Examples include cameras and sensors that monitor patient and staff compliance with hand sanitization policies to reduce infection rates, devices that ensure discharge instructions are fully followed, telesitters to improve patient safety and reduce fall risk in post-acute care step-down patients, and connected pill bottles that confirm medical adherence.

Enhanced pharmaceutical drug supply chain safety – Edge and IoT devices and sensors can reduce the risks inherent in the healthcare supply chain, including temperature-related and counterfeit risks. Examples include devices that continuously monitor temperature changes in vaccines during transportation to ensure that safe temperature range is maintained, RFID sensors that track medication from the point of manufacturing to the point of consumption, and GPS-enabled shipping containers that improve inventory and waste management and distinguish between goods in transit and goods stolen.

New opportunities to enhance precision medicine research – Sensor-generated data, combined with medical-grade software applications, make it possible to treat rare medical conditions previously too expensive to address. Examples include wearables and other sensors integrated into the clinical trial process to expedite study completion and improve clinical compliance and reporting, along with digital therapeutic capabilities, such as applications that allow for the automatic collection and use of individual health data.

Where we are today – The sky’s the limit when it comes to the opportunities to use edge computing in health care, says Paul Savill, senior vice president of product management and services at technology company Lumen, especially as health systems work to reduce costs by shifting testing and treatment out of hospitals and into clinics, retail locations, and homes. That is not simply buzzword-driven hype: covid-19, for example, has laid bare the need for health-care options outside the doctor’s office or hospital. There are hundreds of healthcare uses that rely on low-latency, remote, real-time results, from pop-up clinics and cancer-screening centers to patient-monitoring systems, including pacemakers and insulin pumps.

My take – While some technology applications are still in their early stages, edge computing will ultimately help solve problems that cloud computing cannot. Edge computing can act as the “glue” that takes the benefits of exponential technologies like 5G cellular technology, The Internet of Medical Things, digital health sensors, and remote patient monitoring and combines them into a comprehensive tool that can be applied at the point of care to improve clinical outcomes and increase the quality of life for patients everywhere.

But, edge computing in healthcare is domain-specific and needs support from healthcare organizations. It is necessary to work with domain experts to ensure that the system can play in real life. Healthcare organizations will need to bring all stakeholders to the table to discuss their requirements and needs, so they have a better chance of moving forward to applying edge computing to healthcare domains.

The widespread adoption of healthcare IoT devices and edge computing will make people more aware of their health status. It will also make advanced healthcare resources available in remote areas via telemedicine. The ability for caregivers to regularly keep tabs on their patients will reduce the rehospitalization rate significantly. As collaborative edge computing and machine learning can preprocess data and generate meaningful analytics in real-time, caregivers will spend less time collecting and analyzing data and more time caring for their patients.

The “Big Tech” Company in Health Care You May Not Know

“For over a decade we have partnered with the medical devices ecosystem to bring innovative diagnostic imaging, robotic surgery and patient monitoring devices to the market.”

Kimberly Powell, Vice President of Healthcare of NVIDIA
Image Credit: Shutterstock.com

Whenever you see articles about big tech companies entering or expanding their work in health care, including one of my previous posts, they generally feature the FAMGA (Facebook, Apple, Microsoft, Google, and Amazon) companies. (Does the acronym need to be changed to MAMGA now that Zuckerberg has decided to try and make his problems go away by changing the company name to Meta? But, I digress….) A recent post by Dr. Bertalan Mesko, The Medical Futurist, added NVIDIA to the list. Now I knew that NVIDIA’s graphic processing units, long considered the gold standard for gaming applications, were used in medical imaging equipment to process large imaging files and support machine learning and AI applications. But I didn’t clearly understand how much of an emphasis NVIDIA was placing on the health care segment of their business.

The GPU manufacturer launched its A.I. platform, Clara, in 2018, designed to augment medical imaging and genomics. It followed up a year later with a toolkit for radiologists, Clara AI, to help classify images. In 2019, the tech giant also started exploring federated healthcare learning, the privacy-focused A.I. training method.

NVIDIA took an interest in the rise of telemedicine during the pandemic. Last September, NVIDIA announced that its researchers are working on an automated speech recognition tool for healthcare. It has been specifically trained to interpret clinical and biomedical language. As such, the software can help transcribe and better organize information from telemedicine visits.

Last October, NVIDIA also made healthcare-related announcements during the company’s annual GPU Technology Conference (GTC). Among those was the A.I. model that their researchers, along with the Massachusetts General Brigham Hospital, developed in 20 days. Their algorithm can determine the oxygen needs of a patient with COVID-19 symptoms. It combines health records and radiological images to help identify whether the patient will require additional oxygen hours or even days after an initial exam.

Also last October, NVIDIA announced its plans to build a computer, but rather than use it for gaming, it will aid in A.I. research in healthcare. Named Cambridge-1, it will be no regular computer either as it will be the UK’s most powerful supercomputer. Dedicated to advancing healthcare, Cambridge-1 is a $100m investment by Nvidia. Its first projects with AstraZeneca, GSK, Guy’s and St Thomas’ NHS Foundation Trust, King’s College London, and Oxford Nanopore include developing a deeper understanding of brain diseases like dementia, using AI to design new drugs, and improving the accuracy of finding disease-causing variations in human genomes.

“The Cambridge-1 supercomputer will serve as a hub of innovation for the UK and further the groundbreaking work being done by the nation’s researchers in critical healthcare and drug discovery.”

Jensen Huang, NVIDIA founder and CEO

In March, the tech giant announced a partnership with Harvard University to develop an A.I.-based genome research toolkit. Named AtacWorks, it is even touted as being able to sequence a whole genome in 30 minutes. The tech company also plans to assist drug discovery with A.I. NVIDIA announced in mid-April a new A. I. project with pharma giant AstraZeneca and the University of Florida to boost drug discovery. The new drug-discovery model, named MegaMoIBART, is aimed at “reaction prediction, molecular optimization, and de novo molecular generation.” NVIDIA also announced during its 2021 GTC event its collaboration with Carestream Health, a medical imaging specialist. The latter will incorporate NVIDIA’s Clara A.I. platform into imaging devices used for X-ray screening.

My take – These recent developments indicate a rather focused path for NVIDIA in healthcare. While its plans aren’t as diverse as that of Amazon or Google, by focusing on its computing strengths, NIVIDIA positions itself as a company to watch in health care data and analytics. They believe that AI will be critically important in the future. So, they’re leveraging their strengths in that area to support clinical applications in medical imaging, digital pathology, cancer, genomic research, Alzheimer’s research, drug development, and physician training.

Demand for NVIDIA’s Graphics Processing Units (GPUs) and Data Processing Units (DPUs) will continue to grow as the data requirements in health care accelerate over the next decade. They’ll be a significant player in supporting scientific research and clinical care in the future.

Health Tech News This Week – October 30, 2021

What happened in health care technology this week – and why it’s important.

Image Credit: Shutterstock.com

The Blockchain is making domain names more private – for good or bad

A Microsoft report raises the alarm about a new kind of domain name that it says is ripe for abuse by cybercriminals. As Rob Pegoraro reported in Fast Company online, “The next big threat” is how Microsoft’s latest annual security report characterizes domain names written into a distributed ledger maintained across a constellation of computers instead of stored in a traditional, centralized registry. Storing domain names on a blockchain can make them difficult to shut down or even trace to their owners. It also leaves them inaccessible without special software or settings.

“In recent years, we have observed blockchain domains integrated into cybercriminal infrastructure and operations,” the report says, nodding to Microsoft’s experience last spring disrupting a botnet called Necurs. The potential for abuse led a group called OpenNIC, which promotes alternatives to the traditional domain-name system, to vote in 2019 to block the .bit domain lest the organization be “directly responsible for the creation of a whole new class of malware.”

Why it’s important – As I outlined in a previous post, blockchain applications in health care are many, and the potential to solve some significant challenges is encouraging. But, as with any developing technology, some bad actors will use the technology for nefarious purposes like ransomware. It’s important to follow developments in this critical area to understand what companies like Microsoft are doing to minimize the risk associated with blockchain use.


Scientists used a tiny brain implant to help a blind teacher see letters again

A former science teacher who’s been blind for 16 years became able to see letters, discern objects’ edges — and even play a Maggie Simpson video game — thanks to a visual prosthesis that includes a camera and a brain implant, according to American and Spanish researchers who collaborated on the project. Bill Chappell reported on the research project in an article on NPR this week.

The test subject had the implant for six months and experienced no disruptions to her brain activity or other health complications, according to an abstract of the study that was published this week in The Journal of Clinical Investigation. Some of the prosthesis’ effects were limited; it did not let Gómez identify all letters of the alphabet, for instance. But she “reliably discriminated some letters such as ‘I,’ ‘L,’ ‘C,’ ‘V’ and ‘O,’ ” according to the study.

Why it’s important – The study furthers what it calls a “long-held dream of scientists” to impart a rudimentary form of sight to blind people by sending information directly to the brain’s visual cortex. The method of bypassing the eyes altogether could someday restore vision to roughly 148 million people worldwide — that’s how many people have had the link between their eyes and their brain severed, the researchers say, due to conditions such as glaucoma or optic nerve atrophy.


CrossFit to launch ‘fully digital’ primary care service

Kat Jercich reports that the fitness company will join other startups in offering direct-to-consumer virtual care services, in addition to precision health and preventive medicine in HealthITNews. CrossFit is offering its new services in partnership with the Wild Health platform, which says it uses a DNA kit to “analyze the genetic advantages, predispositions, and disadvantages [making] up your human operating system.” Users who need specialty or in-person care can be referred elsewhere, although CrossFit says it hopes to build a CrossFit-affiliated network of specialists eventually. The service is not covered by insurance, but its approximate $100 monthly subscription fee is eligible for Health Savings Account coverage.

Why it’s important – Crossfit joins many other consumer fitness companies in jumping into the “virtual care” market. The upside is that there are many options to choose from at different price points to meet the consumers’ ability to pay. But some experts caution that a massive shift to telemedicine for primary care may exacerbate healthcare disparities, particularly for people who already face hurdles to accessing services.


AI Generates Hypotheses Human Scientists Have Not Thought Of

Creating hypotheses has long been a purely human domain. Now, though, scientists are beginning to ask machine learning to produce original insights. Robin Blades reports on this trend in an article in Scientific American this week. Electric vehicles can substantially reduce carbon emissions, but car companies are running out of materials to make batteries. One crucial component, nickel, is projected to cause supply shortages as early as the end of this year. Scientists recently discovered four new materials that could potentially help—and what may be even more intriguing is how they found these materials: the researchers relied on artificial intelligence to pick out valuable chemicals from a list of more than 300 options.

Several years ago, Anant Madabhushi, a professor of biomedical engineering at Case Western Reserve University, used interpretability techniques to understand why some patients are more likely than others to have a recurrence of breast or prostate cancer. He fed patient scans to a neural network, and the network identified those with a higher risk of cancer reoccurrence. Then Madabhushi analyzed the network to find the most important feature for determining a patient’s probability of developing cancer again. The results suggested that how tightly glands’ interior structures are packed together is the factor that most accurately predicts the likelihood that cancer will come back.

Why it’s important – The Case Western Reserve University example demonstrates that using AI, interoperability techniques, and neural networks can overcome the inherent human biases that often factor into the data used to train machine learning algorithms by encouraging them to think in new ways. This can have profound implications for disease research in the future.

Some Straight Talk on How Technology Will Impact Clinical Trials

“Tech solutions can bring the trial to the patient, and automation of the data collection/cleaning process. Both would cut down costs of generating clinical trial data considerably – which is the single biggest cost to drug manufacturers.”

Ruby Saharan, Senior Medical Advisor- RWE, Novartis Oncology UK and Ireland
Image Credit: Shutterstock.com

Clinical trials are incredibly costly and time-consuming endeavors. The average cost to conduct a Phase III trial is estimated at US$20 million, with a median of $41,117 per patient and $3,562 per patient visit. These expenses have reportedly risen by 100% in the last 11 years. With a push to lower the commercial price tags of new drugs – and find ways to get them to market sooner – pharmaceutical companies and regulatory bodies are increasingly more open to new clinical trial methodologies and tools. In parallel, during the current covid-19 pandemic, the pharmaceutical industry is further forced to shift away from traditional clinical trial modalities with a bricks-and-mortar approach – where patients must go to a clinical site for dosing and follow-up – to a more patient-centric approach where the trial comes to the patients in the form of digital enablement. In just a few months, 1,100 clinical trials were disrupted due to lockdown mandates, limited access to clinical sites, and people’s shift in priorities and comfort levels.

It is clear that the $52B clinical trials market needs a makeover. Startups and big tech are actively developing clinical trial solutions, from IoT for remote monitoring to machine learning for electronic health record (EHR) processing to AI-based cybersecurity for data protection. A new report from Research2Guidance (purchase required) discusses the rise in digital decentralized clinical trial (DDCT) technologies since the COVID-19 pandemic. The DDCT solution and service market in Europe and North America (NA) is $1.79 billion (€1.54 billion) and is predicted to grow by 38.5% (CAGR) to reach $9.13 billion (€7.84 billion) by 2026.

“I am impressed by the breadth of service offerings already available from DDCT companies. Solutions are innovating every step of the clinical trial process, from site selection to patient recruitment, and patient onboarding to long term data monitoring.”

Ralf Jahns, Managing Director, Research2Guidance

Now is the time for innovations in clinical trials to provide a patient-centric approach to driving patient engagement and capturing remote and accurate clinical data (including primary endpoints and patient-reported outcomes) and to drive down clinical trial costs. So how might technology innovation impact digital clinical trials? Here are some key areas to consider:

Finding a clinical trial – Matching the proper trial with the right patient is a time-consuming and challenging process for both the clinical study team and the patient. According to research by CB Insights, Roughly 80% of clinical trials fail to meet enrollment timelines, and around one-third of Phase III clinical studies are terminated because of enrollment difficulties. Patients may occasionally get trial recommendations from their doctors if the physician is aware of an ongoing trial. Otherwise, the onus of scouring through ClinicalTrials.gov — a comprehensive federal database of past and ongoing clinical trials — often falls on the patient. Artificial intelligence and machine learning can help extract and analyze relevant information from a patient’s EHR records, compare eligibility criteria for ongoing trials, and recommend matching studies. The challenges in making this work include unstructured data and EHR interoperability.

Challenges with enrollment – Unfortunately, enrollment challenges do not end when a patient chooses a clinical trial. To confirm eligibility, the patient must complete a preliminary phone screen and then undergo examination by a participating site in person or virtually. Every trial includes inclusion and exclusion criteria that each patient must meet to participate. These terms are often riddled with medical jargon that is difficult for patients to decipher. Telehealth services could help streamline this process. If eligible, the patient signs a consent form agreeing to the terms of the clinical trial. This includes awareness of potential side effects, willingness to provide biological samples, and covering expenses not included within the study budget. Solutions using AI to extract information from patient medical records can help simplify the enrollment process by automatically verifying some of the inclusion and exclusion criteria.

Medication adherence – Once patients enroll in a study, they receive the experimental study drug (or placebo). Patients go home with the first course of the medication (for example, a 30-day pill bottle with instructions on dosage) and a diary to fill out daily. Many clinical studies still use paper diaries instead of electronic systems. Patients are asked to note when they took the study drug, what other medications were taken on those days, and any adverse reactions (including headache, stomach ache, or muscle aches). This process is plagued with inefficiencies, including reliance on the patient’s memory, use of paper documents and fax machines to communicate with physicians, risk of dropout. AI and wearables offer real-time, continuous monitoring of physiological and behavioral changes in patients, potentially reducing the cost, frequency, and difficulty of on-site check-ups.


What about clinical trials for rare diseases? – The FDA classifies more than 6,000 diseases as rare, which means that they affect less than 200,000 people in the United States. Only 5% of these diseases currently have FDA-approved treatments. The first challenge of rare disease trials is the most obvious: it’s hard to find patients. Around 3.5%-6% of people have a disease classified as “rare.” An even smaller percentage will have the specific disease that a clinical trial is attempting to study. Rare disease trials often need to recruit patients from around the world to meet their enrollment goals. But having sites in multiple countries participating means the trial must receive approval from multiple complex regulatory bodies. It also means sponsors must collect and monitor documents and data from many different sites, which involves complex privacy and data regulations and can slow down trials.

One recent example was the decision by the FDA which refused to review Stealth BioTherapeutics’ Barth syndrome drug, telling the company results in a study of just eight patients are insufficient to support its submission. The impasse highlights the challenges of testing drugs for ultra-rare diseases. Barth is so rare that Stealth is unsure it can recruit patients to run a new study

Technology can help rare disease trials increase recruitment rates, improve communication, speed up their workflows, and make the most of the funding they have. Patient recruitment software to identify eligible patients, as well as telemedicine and eConsent to manage remote patient visits, are excellent options for rare disease studies.


How big tech is supporting digital clinical trials – Big tech companies are leveraging their mobile devices to build platforms that span across the clinical trial process. Since 2015, Apple has been building a clinical study ecosystem around the iPhone and Apple Watch, both of which enable real-time health data collection. Its open-source frameworks — ResearchKit and CareKit — help clinical trials recruit patients and monitor their health remotely.

Google has been more active in the space. The company is building a clinical research ecosystem through its Google Health Studies Android application and developing products through its life science subsidiary, Verily Life Sciences. Verily launched Project Baseline in 2017 to fuel medical research by mapping human health. By mid-2019, Novartis, Sanofi, Otsuka, and Pfizer had partnered with Verily to use its tools for more efficient clinical trials. The initiative has also partnered with Stanford Medicine, the Duke University School of Medicine, and the American Heart Association. In April 2020, Google opened its Cloud Healthcare API to health systems and quickly signed on top medical centers such as Mayo Clinic. These actions follow Google’s 2018 pledge to support healthcare interoperability and data-sharing standards (also signed by Amazon, IBM, Microsoft, and Salesforce). And just this week, Google Care Studio has unveiled a new mobile version of its clinician-facing search tool that helps organize patients’ medical records. The company pitches this new modality as a way for doctors to check in on a patient or access patient information on the go. Currently, Google is in the process of acceptance testing with Ascension and Beth Israel. The company is looking to pilot the tool in Q4 with Ascension. Here’s a short video from Google describing Care Studio:

Another tech company that may enter the space is Facebook, which launched its Preventive Health tool in late 2019. Given the depth of personal data that Facebook captures and its self-organizing communities around health issues, this may be the first step toward a clinical trial recruitment solution.


What platforms are being developed to support digital clinical trials? – Needless to say, with all of the interest in developing digital clinical trials, there are dozens of companies looking to develop platforms to streamline the workflow across the entire process. The best summary of the current state of the market that I’ve found was reported by Andrea Coravos on her Medium blog. She did a superb job of collecting and summarizing the various market segments, as you can see in the graphic below:

Image Credit: Andrea Coravos, 2018 blog post

I love her segmentation model, and her most recent article in Health Affairs on how these digital clinical trials will affect patients’ lives is a must-read.


My take – Today’s potential participants tend to be digital consumers who demand convenience, personalized engagement, and active participation in clinical trials. They want to use digital tools to integrate trial protocols (like medication adherence and care) into their daily lives and not reshape their lives to accommodate the protocols. Each year, more clinical trials incorporate digital tools to monitor patients remotely. Harvard researchers reviewed every trial registered with ClinicalTrials.gov between 2000 and 2017 and found the use of digital tools increased at a 34% compound annual growth rate. Across the study period, the number of registered clinical trials using these devices grew more than tenfold, from eight trials in 2000 to about 1,170 trials in both 2017 and 2018.

Studies have also shown that people are more willing to participate in mobile trials than traditional ones. In a recent survey on patient preferences for using mobile technologies in clinical trials, when given a choice in how to participate in a trial, 81% of respondents reported they were willing to participate in a mobile trial. In comparison, only 51% were willing to participate in a traditional trial.

Many challenges remain, and lessons will be learned as digital research is moved into the mainstream. Still, knowledge of the innumerable benefits to clinical research reinforces the view that now is the time to support digital methods with a focus on learning the most effective and efficient processes.