In the past 21 months since Covid-19 became a public health crisis, adoption of virtual health solutions has accelerated in an effort to mitigate risk. Although once regarded as a useful companion to in-patient visits, virtual care as a default starting point for healthcare delivery is becoming increasingly common, thanks to CMS reimbursement. And that’s becoming the norm not only for many primary and some urgent care delivery, but also for specialty areas such as behavioral health. National retail chains such as CVS Health and Walgreens have adopted platforms to support Virtual First Care (Virtual1Care). Amazon Care embraces Virtual1Care – it’s made the service available to its employees across the country and other companies are beginning to use it as well, particularly Hilton.
Virtual1Care is part of a wider trend we’re seeing in the restructuring of healthcare. In order to benefit from this trend, pharma and medtech companies must ensure that their digital health tools, wrapped around a drug or device, comply with evolving regulations. In an interview, BrightInsight CEO and Founder, Dr. Kal Patel discussed how Virtual1Care is shaping digital health adoption, some of the regulatory shifts underway in digital health and how BrightInsight is collaborating with companies to fulfill this new vision of healthcare.
One deal that underscores this trend is the digital health collaboration between Fitbit, owned by Google, and Verily’s virtual clinic – Onduo. The collaboration pairs Onduo’s chronic condition platform with Fitbit’s devices and Fitbit Premium as part of the company’s approach to whole person health. It seeks to provide a comprehensive view of how the different aspects of health and wellbeing fit together, including activity, sleep and stress, to help participants better manage their health and build a routine that works for them, according to the September announcement.
These kinds of collaborations are also taking place in life sciences, for the same reasons. 
“How do you leverage continuous data sources in ways that drive intervention with the patient that go beyond a patient interaction having to be a face to face clinical visit?” Patel asked.  
“Our whole portfolio speaks to the potential and the power of what you can do by wrapping regulated software around traditional drugs and devices.”
Digital health investment soared to new heights in 2021, particularly for companies developing virtual care tech. As a company that provides the infrastructure for pharma and medtech companies to develop and scale regulated digital health programs, BrightInsight benefited from this investment trend as well. In the first quarter, it closed a $101 million Series C round led by General Catalyst.
Patel’s background in digital health in pharma at Amgen, with telemedicine provider Doctor on Demand and more recent experience as president of Flex Digital Health makes him well suited to lead these collaborations. One example of how BrightInsight is helping life science companies execute on their digital care ambitions is its collaboration with Novo Nordisk to support people with Type 2 diabetes. 
The pharma company needed a regulated digital health platform to help it build and operate a suite of digital health products and services to improve diabetes care. In addition to an open, device-agnostic platform that could capture data from continuous blood glucose meters and insulin pens, Novo Nordisk required a regulated platform designed to satisfy the stringent privacy, security, regulatory and quality requirements of US and European healthcare regulatory bodies. One of the challenges that companies seek to address is to improve the way patients manage their chronic conditions. At least 45% of people with type 2 diabetes have a tough time managing their blood sugar levels and medication adherence is one contributing factor.
The collaboration with BrightInsight helps people with diabetes unlock real world data. By integrating user’s blood glucose data with automatically recorded insulin dose data from Novo Nordisk’s smart insulin pens, users can better understand how their activities, diet, and insulin intake play a role in their levels and make more informed decisions to keep their glucose levels within safe parameters. 
Although there are numerous companies developing digital health solutions, if they can’t adapt to regulatory shifts, they risk falling behind or becoming irrelevant. Earlier this year, the EU regulatory body mandated a series of changes directing how companies need to manage software medical devices, which went into effect May 26. The changes were designed to ensure a high standard of safety and quality as regulators try to keep up with the pace of health tech innovation while maintaining the need for safety and efficacy. The FDA shared draft guidance for planned changes to premarket submission of digital health technology – the original version dates back to 2005.
The FDA has indicated that it’s updating software medical device guidance so that each software device will fall into one of two buckets: basic or enhanced, according to a blog post on BrightInsight’s website. The updated draft guidance is the FDA’s attempt to keep up with the influx of cutting-edge submissions.  By focusing on basic and enhanced risk, they eliminate the middle ground and streamline the submission process.
“This is reflective of the FDA’s view of low risk/high risk when it comes to devices,” said Sonia Nath, a partner with Cooley law firm in a BrightInsight blog post. “This may be announced as a simpler risk-based approach to viewing software devices generally…The thinking behind this guidance is, if we tell you more explicitly what we need, you can get through the approval process more quickly because there’s not going to be so much back and forth. Technology is always faster than the law and the guidance documents.”
The new draft guidelines will require that submissions for “high risk” software devices are accompanied by more design documentation spelling out the technical design details of how the software functions, how the software design implements all the requirements of the Software Requirement Specification (SRS) and how the Software Design Specification (SDS) traces to the SRS in terms of intended use, functionality, safety, and effectiveness. 
The convergence of pharma, medtech and providers through digital health data over the past few years has been a fascinating transformation. Pharma companies such as Takeda and Sanofi are developing specialty practices to gain greater insights on market dynamics and what patients need. Patel noted that health data has become a critical commodity.
“For pharma and medical device companies, there will continue to be a tremendous expansion and focus of their resources going into software,” Patel said. “You will have multiple sources of health data that can answer questions from disease diagnosis to matching patients with the right therapies.”
He added: “I think all disease areas are amenable to digital solutions.”
Virtual health visits are poised to increase in 2022 as will the need for regulated connected devices and Software as a Medical Device (SaMD) to monitor patient health between medical appointments. Collecting and analyzing data from these devices is not only critical for spotting potential problems with dosages, device usage and the overall health of patients; they can also make the interaction between patients and their clinicians more meaningful with the insights they can provide to them. The digital health offerings across pharma and medtech will continue to expand and become more robust across chronic conditions and specialized areas such as oncology and rare diseases. It will be interesting to see the form these collaborations take in the new year. 
Photo: NicoElNinom, Getty Images

GE Healthcare will expand its ultrasound business into the operating room. The company closed its planned $1.45 billion acquisition of surgical visualization company BK Medical.
BK Medical, which has headquarters in Boston and Copenhagen, currently has more than 650 employees. It has been experiencing double-digit revenue growth, the companies said in a news release. 
While GE Healthcare currently uses ultrasound for preoperative and postoperative visualization, the acquisition would also give it the ability to use ultrasound in real-time during a procedure, to help surgeons make decisions. BK Medical would also be able to reach new customers in new markets as part of GE. 
BK Medical CEO Brooks West will continue to lead the company, and it will operate as part of GE Healthcare’s $3 billion ultrasound business. 
 “We have been on a journey to change the standard of care for surgery by making it possible for surgeons to make critical decisions in the operating room using real-time advanced visualization, allowing for better care, faster surgeries and reduced complications,” West said in a news release. “Together with GE this journey will continue, and we can look forward to making a greater impact in healthcare around the world.”
GE is currently in the process of spinning out its healthcare division as part of a broader restructuring. Last year, the division brought in $18 billion in revenue. GE Healthcare would become a separate, publicly traded company in 2023, with GE keeping a 20% stake.
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“So, tell me what happened to your mother,” she said. I get asked this question a lot since losing my mother to a Clostridioides difficile infection (CDI) in April 2010. Over the past eleven years, I have told her story to tens of thousands of people in a variety of settings, and documented it in several articles, op-eds, podcast, news stories and videos op-eds, podcasts, and videos.
Sometimes telling her story reinforces our deep love for each other, which makes me feel good. At, other times, I want to stick my head in a well and scream until I’m hoarse. Occasionally, it makes me feel flat and disconnected. And sometimes, it brings me right back to the white-hot rage that I felt in the months after she first died. But I still consider telling the story of who my mother was and what happened to her to be a sacred duty. In sharing the incomparable and unreconcilable loss my family experienced when my mother was killed by a preventable healthcare associated infection (HAI) at just 56-years-old, I seek to both honor her memory and her life’s work as an educator and to ensure that her death will not be in vain.
What follows is guidance that I have developed over more than a decade of telling my mother’s story as we build a movement to end preventable harm from CDI and other HAIs. We offer it to healthcare workers, hospital administrators, journalists, nonprofit leaders, government officials, industry leaders, and others who want to invite engage a patient safety advocate to share their story at an event, or to collaborate on a research or awareness project. People who have been harmed very often want to share their experience, both as catharsis and to help prevent others from being hurt.
But doing so can come at a cost. Reliving the brutal 36 hours from when I arrived to take my mother to the hospital to the ICU doctor telling us she had died is mentally and emotionally draining. So while we welcome the invitation, the following “DOs and DON’Ts” will help ensure that the experience is optimal for people like me.
Do your homework. Survivors of medical harm and their loved ones frequently recount our stories to raise awareness and advocate for change. If we’re established enough to be on your radar, it’s highly likely that our story is available online. Read it BEFORE you contact us. And do not ask us to “tell you what happened” during an initial conversation. Reliving the harm or loss we’ve suffered takes an emotional toll every time we do it. Respect that we have a right and duty to ourselves to share our stories only when it can have a tangible impact.
Don’t ask invasive questions (or let your audience do so). Telling our stories requires us to be very vulnerable. To both connect with our audiences and have the desired impact, we choose to share extremely personal aspects of our lives. That may include graphic details of the medical harm we’ve experienced, our emotional state during and after the harm, efforts we have made to heal ourselves such as therapy, psychiatric treatment or legal remedies. Unless specifically invited, questions related to those aspects of our lives should be avoided, as should questions about our families, marriages and children. The trauma of medical harm ripples through our families and friendships, so respect our privacy.
Don’t expect tears. I rarely cry when recounting the story of my mother’s death. I suspect that’s due to her not being a big crier and my being an experienced public speaker. I occasionally tear up and get a lump in my throat. But that’s usually it. I have and do still cry plenty in private.
Do be prepared for tears. Of course, I know many patient advocates who cry every time they tell their story. Some do it very openly with a lot of calm. Some do it with a barely contained anger. Some sob and some just let tears fall. Some do it unexpectedly even to themselves. Whatever way it happens, you should be prepared to offer tissues, water, and allow us a moment to compose ourselves before continuing.
Don’t ask us to layout money for transportation or lodging. More than one-third of American families do not have $1,000 in savings for an emergency. People who experience a chronic illness, terrible injury or medically related harm, are less likely to have any savings. Many have lost some or all their income. A portion will be living on disability and Social Security payments. Most of us cannot afford to lay out the money for a plane ticket, hotel room and other travel-related costs.
Do pay us. I presented at professional associations and quality improvement meetings for five years before asking to be paid. At the time, I was working full time while also running Peggy Lillis Foundation, in memory of my mother, so I didn’t “need” the money. But every hour I spend preparing, traveling to or delivering a presentation was time away from fundraising for PLF or implementing our programs. That revenue has to be made up. Even if your speaker doesn’t have an organization to run, the time it takes to craft and deliver a presentation deserves compensation.
Other reasons to compensate patient advocates include:

Diversity. Medical harm affects Americans from all demographics, but the structural impediments of racism, sexism and classism mean that patient advocacy is mostly filled with college-educated white people from the professional class. Compensating speakers would go a long way toward ensuring that people from marginalized communities – who struggle to access care and are more likely to be harmed – are able to share their experiences and shape the discourse around patient safety.
Disparate benefits. Patient advocates do not benefit from continuing medical education credits or resume building that serves as compensation for many speakers. Those intangible benefits – free conference participation, etc.- can serve as material compensation for healthcare workers but not for us.
Economic justice. Americans spend $3.6 trillion on healthcare, yet we receive less and poorer care than other Western post-industrial nations. Further, if we experience medical harm, our most likely course of redress is a civil lawsuit. And most lawsuits brought against physicians and hospitals are found in favor of the defendant. The average legal settlement for medically-related wrongful death is just under $350,000. Worse, so-called “tort reform” has made is incredibly difficult to even bring a suit in many states as caps on damages mean fewer attorneys will take a case on contingency.

Don’t reduce us to our story. Patient advocates have a lot more to offer than just our stories. We come from all walks of life, bringing diverse perspectives, skills and knowledge. In my time as a patient advocate, I have met HVAC experts, nurses, chemists, data infrastructure experts, x-ray technicians, pharmacists, schoolteachers, law professors, hair stylists, and people from countless other professions. Beyond the knowledge we have at the time of our loss, injury or diagnosis, patient advocates are often self-taught experts on their illness, healthcare policy, regulatory issues, peer support and navigating the healthcare system. We bring a wide range of policy, technical and lived experience that can inform every aspect of healthcare. Not every patient advocate can or wants to engage more deeply than sharing their story, but we should never be reduced to that.
Albert Einstein said, “We cannot solve our problems with the same level of thinking that created them.” Patients and family members have a critical role to play in articulating the dangerous gaps and blind spots in our healthcare system as well as developing solutions. To be effective, we need for healthcare leaders to engage with us as far more than our stories.
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A recent webinar on connected devices and the keys to setting up an effective remote patient monitoring solution offered insights on connectivity and security considerations. It also shed light on why medical devices should embrace connected care platforms and how it influences patient experience and engagement.
Israeli company BioT, which builds a connected care platform which transforms medical devices into connected care solution , sponsored the webinar, which included speakers Itai Weissman, vice president of product for BioT, and Dr. Allen Burton, medical director for medical device manufacturer Abbott‘s neuromodulation business.
Abbott developed Neurosphere, a neuromodulation platform for a suite of products that helps clinicians and patients manage chronic pain and their condition associated with spinal cord stimulation or dorsal root ganglion therapy. Its myPath  app helps track and report patients’ perceived pain relief and general well-being. Neurosphere also enables clinicians to connect to the patient’s neural implant and make changes as needed while communicating with patients in their own home.
BioT highlighted the efficient process by which it can help medtech companies easily connect to cloud and get to market within days  and some of the services it provides.
Both Weissman and Burton noted that some of the value of connected devices and digital tools are that they have improved the quality of care and interactions between patients and their physicians.
“Patient-reported outcomes until today have largely been tethered to validated tools that often rely on questionnaires or the patient’s subjective responses,” said Burton. “As we’re able to move into digital care, there are so many rapidly developing ways to objectively assess patient outcomes, including a variety of different tools that are embedded in our smartphones like Apple Health Kit. We’re really bringing the way doctors have cared for these patients into the digital arena.”
Other key takeaways from the webinar included:

Patients need to perceive value beyond just reporting their data. Ask patients the right questions at the right time to create a fully personalized experience.
It is a significant commitment from the company to find and build the expertise needed for a connected device platform. Consider partnering with ready-made no-code connected care platforms that are easy to set up by using the drag-and-drop modular template approach.  
A connected system is not the goal; it is the means to an end goal which is successful remote patient monitoring and improved treatment outcomes.
Bring your own core competency into play without the need to develop cloud cybersecurity know-how 
HIPAA has its own set of challenges but the data privacy terrain gets more complex as companies expand globally.

To access the webinar on demand, click here.
Photo: marchmeena29, Getty Images

Medtronic recently expanded a recall of its MiniMed 600 series insulin pumps due to broken retainer rings.
The Food and Drug Administration slapped Medtronic with a warning letter related to inadequate medical device quality requirements for its diabetes business. Specifically, the warning letter refers to issues with risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events.
In July, the FDA inspected Medtronic’s Northridge facility, the headquarters for its diabetes business, after a recall of Medtronic’s MiniMed 600 series insulin pumps.
Medtronic disclosed the warning letter in a Wednesday news release, and said it would implement corrective actions and process improvements in response. However, the company shared few details on what those actions would entail.
“We are committed to fully resolving all observations as effectively and quickly as possible, Sean Salmon, president of Medtronic’s diabetes business, said in a news release. “Nothing is more important to us than providing the highest quality products to people living with diabetes.”
Recalls of the insulin pumps began in 2019, when broken retainer rings resulted in patients receiving the incorrect dose of insulin. Medtronic recently expanded the recall to include all of its MiniMed 600 series insulin pumps, to replace the retainer ring with a more durable version.
Separately, Medtronic also recalled the remote controller for its MiniMed 508 and Paradigm pumps for potential cybersecurity risks.
Medtronic’s stock fell 6% on the news Wednesday, while competitors Tandem and Insulet saw their stocks rise 10% and 5% respectively.
 In a filing, Medtronic said it expects its diabetes business will be affected, with a revenue decrease in the high-single digits for the third quarter, and in the mid-single digits for fiscal year 2022. The company does not expect to change its overall earnings guidance for next year, but could potentially see a slight impact to its revenue growth in 2023.

In the United States, over 550,000 people with end stage renal disease (ESRD) are dependent on dialysis care, accounting for over $36 billion a year in Medicare spending. Of those patients, 65,000 reside in skilled nursing facilities (SNF) and long-term care (LTC) facilities. As life expectancy continues to climb due to improved treatments for cardiovascular disease, cancer and other comorbidities, a steep increase in the number of frail and/or elderly patients requiring dialysis within a SNF or LTC facility is expected.
There are many pathways that lead patients to LTC facilities, requiring dialysis. In some cases, patients suffer kidney failure and functional decline after a catastrophic health event and prolonged hospitalization. Sadly, many dialysis patients deteriorate physically and cognitively, such that their care needs exceed what can be currently addressed in the home setting. The additional need for life sustaining dialysis adds increasing complexity to this mix.
For patients living in a skilled nursing or long-term care facilities, transportation to and from a dialysis clinic three-times-a-week, often in specialized vehicles accommodating wheelchairs or stretchers, is typically required. For frail and vulnerable patients, this is an exhausting and – at times – dangerous trip. Furthermore, the cost of this specialized transport presents another undue burden to patients, as transportation to and from medical appointments – unless in the case of emergency – is not covered by Medicare.
Though innovation has been needed for ages, the Covid-19 pandemic forced dialysis providers to think of better treatment models. Transportation to and from dialysis centers, time spent waiting for treatment, and hours tethered to machines in close proximity to other patients renders social distancing virtually impossible. As a result, a persistent concern with no immediate solution is the potential risk of transporting an infected patient back to the care facility with other vulnerable patients. Illustrating the deadly impact of this challenge, to date, approximately 31% of all Covid-19-related deaths have been linked to LTC facilities in the United States.
While the Covid-19 pandemic further complicated dialysis care for patients and providers alike, it’s clear that traditional, in-center dialysis never “worked.” In fact, studies show that dialysis patient death and emergency room utilization is more apt to occur on Mondays and Tuesdays, due to a long 2-day gap in treatments over the weekend.
In particular, the first 90 days of dialysis remain a period of high cost, high admission rates and mortality. A lack of sufficient pre-dialysis and transitional care is a significant contributing factor to this reality—nearly 40% of patients with end-stage kidney disease (ESKD) initiate dialysis without adequate preparation. So, what’s the solution? A personalized approach to care that caters to patient needs, reduces risks and improves quality of life and outcomes. In many cases, this approach will include ensuring that a patient is effectively transitioned from in-center to home hemodialysis—wherever “home” may be.
Virtually all routine dialysis should be available within SNF and LTC facilities. The technology for this type of care exists and training LTC staff on easy to operate, portable dialysis devices should be the norm. Devices that can be learned to operate in under six hours and utilized by a range of healthcare employees and patients, if broadly adopted, would not only alleviate cost burden but, more importantly, protect the safety and quality of life of our frail and elderly loved ones.
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An IntelliVue MX850 monitor displays  patient’s vitals. Philips recently received FDA 510(k) clearance for its IntelliVue MX750 and MX850 devices. Photo credit: Philips
A year after they were given an emergency nod to be used during the pandemic, two of Royal Philips’ newest patient monitors now are cleared by the Food and Drug Administration. The agency recently granted 510(k) clearance to Philips’ IntelliVue MX750 and MX850, which are designed to provide real-time information on a patient’s vitals and support remote monitoring in a hospital setting.
The FDA initially gave Philips an emergency use authorization for the devices in April of last year, shortly after the start of the Covid-19 pandemic. Given that the devices could be used to remotely monitor hospitalized patients, the intent was to use them to watch hospitalized Covid-19 patients’ vitals without exposing healthcare workers to the virus during a time where masks and other protective equipment were scarce.
Philips says the devices feed encrypted patient data into a hospital’s EMR, offering a real-time view of their conditions. They can connect to devices, such as IV pumps, anesthesia machines and ventilators. The monitors can also support clinical decision support tools, such as one that Philips developed to show changes in vital signs and provide context about a patient’s condition.
The FDA clearance just includes the two monitors, but add-on display screens and a module server rack were also included in the emergency use authorization. The full system has been used in Europe since it received a CE mark in 2019.

Advances in diagnostics have led to cancer screenings that can find the disease at its earliest signs when a therapeutic intervention has a greater chance of success. But making these tests the standard of care will take a little more time. Phil Febbo, chief medical officer at Illumina, said wide adoption will require more awareness of these tests as well as more evidence showing that they work. The gene sequencing giant is doing its part to boost awareness. One of the employee benefits the company offers for those 55 and older is an early detection test.
“I plan on getting it every year,” Febbo said.
Febbo spoke Thursday during a panel discussion at CB Insights Future of Health conference. He was joined by Alicia Zhou, chief science officer of genetic testing company Color. Illumina might be best known for supplying the reagents and equipment used in genetic testing, including cancer diagnostics. But the company’s offerings now include Grail, a diagnostics company that spun out of Illumina and was required earlier this year. Grail developed a test that detects genetic indicators of cancer from a liquid biopsy, a small sample of blood.
The liquid biopsies from Grail and others are intended to detect cancer early, which in turn enables earlier treatment, Febbo said. To help support adoption of these tests, he said that companies need to generate evidence to show that these tests don’t flag false positives. Febbo said that in clinical trials, the false positives for the Grail test were comparable to established screening tests, like mammography. As more evidence from these tests is generated, the case will become stronger for their adoption, Febbo said.
Zhou said that finding greater adoption of genetic testing will require a change in how such these tests are perceived. The high cost of a genetic test meant that who qualifies for such testing was limited. But those costs have been coming down, which means that genomic testing can be used as a piece of data alongside other factors to assess a patient’s health. Scalability of genetic testing is about dropping the price of these tests and making them more widely accessible, Zhou said.
Covid-19 introduced Color to more accessibility issues. As the pandemic unfolded, the company expanded its scope to include Covid testing and vaccine distribution. That led the company to think about barriers to access, Zhou said. More than just having vaccines available, Zhou said it’s important to bring those vaccines to where people are, such as community centers and faith-based organizations. Those sites need to have flexible hours in order to accommodate those who can’t get away from work during the day. Zhou added that community and faith organizations can also help to overcome vaccine hesitancy.
“The work doesn’t stop when you get the approval for the vaccine,” she said. “You need to think about the distribution.”
Zhou and Febbo said that many of the changes sparked in healthcare during the pandemic are changes for the better. A lot of communication between patients and their physicians has moved to Zoom, and Febbo said patients and providers have come to realize that they don’t need to do everything in person. Zhou said the lockdowns led diagnostic companies to search for new ways of reaching patients. Drive through testing, for example, is not something the industry would have tried if not for the pandemic, she said. Clinicians and diagnostic companies found other workarounds. Zhou noted that some testing previously done with an in-person visit to a clinical site can now be done by sending a test kit to a patient’s home.
“These are things we’ll hold on to after Covid,” Zhou said.
Photo: iLexx, Getty Images

PromptHealth, a Canadian wellness platform bridging the gap between conventional and holistic wellness options, has officially launched their new website and app: PromptHealth 2.0. The update makes them a leading one-stop-shop solely for individuals to directly interact with wellness providers. 
Time constraints and over-crowded social media platforms mean wellness providers have to compete for attention among millions of other, non-certified individuals sharing advice. 
PromptHealth 2.0 allows users to discover, learn, and connect with wellness providers with different user-friendly formats, before connecting with them, to help facilitate a better provider-client relationship that results in the best care possible. After launching in 2020, PromptHealth has grown to feature providers from all across Canada and thousands of supporters on all social media platforms.
In the traditional healthcare system, finding treatment is often illness-focused and does not take into account all the elements of our wellbeing – mental, physical, social, emotional, and spiritual health. Instead, it only treats symptoms. PromptHealth was created to solve the gap between people seeking preventative care, and the wellness practitioners who provide complementary solutions to traditional healthcare. 
Check out the new website, or app available on iOS and Android devices. 
To read more, click here. 

Healthmine’s EVP of Consulting and Professional Services Melissa Smith and two of Healthmine’s Senior Consultants, Cynthia Pawley-Martin and Dwight Pattison, wrapped up the Star Ratings Webinar Series with an “Ask Me Anything”-style session just before Thanksgiving. Watch recordings of the entire series to learn everything you need to know about the 2022 Star Ratings for Medicare Advantage plans.
To watch the webinars, click here.

Sound Life Sciences, a spinout of University of Washington, received 510(k) clearance from the U.S. Food and Drug Administration for a prescription only smartphone app which uses the company’s contactless respiratory monitoring sonar software for consumer smart devices. The telehealth startup’s app produces inaudible ultrasonic sonar pulses to detect reflections caused by nearby patient respiration to measure breathing in clinical settings or at home.
Dr. Jacob Sunshine, Chief Medical Officer and co-founder of Sound Life Sciences, talked about the company’s plans for the app.
“With this foundational clearance we have established a regulatory foothold, from which we can build out additional use cases including for respiratory chronic disease management such as asthma and COPD, opioid safety monitoring, infant monitoring, incipient respiratory infection detection and identifying when an unwitnessed cardiac arrest occurs.”
To read more, click here.

Rimsys, which develops regulatory information management software for the medtech industry, has closed a $16 million Series A financing round led by Bessemer Venture Partners. Existing investors also took part, including Allos Ventures, Private Opportunities, and Innovation Works.
Its cloud-based platform helps global medtech companies streamline regulatory processes. It includes an integrated data hub for regulatory information and documents, to help easily access critical information and put it to use in pre-market submissions, and to establish and maintain market authorization.
In 2020, the FDA issued more than 70 guidance documents focused on medtech products, according to Rimsys, and noted that research from MedTech Europe predicts that the new MDR and IVDR regulations in the European Union could lead to a significant number of medical devices (including in vitro diagnostics) being withdrawn from the market.
The company also announced the appointment of two industry veterans, Adam Price and Christine Robertson to its executive team, and that Bessemer Partner Andrew Hedin and Pendo Co-Founder Eric Boduch have joined Rimsys’ board of directors.
To read more, click here.

Health2047, the Silicon-Valley innovation subsidiary of the American Medical Association, has expanded its advisory board with two physician executives and a hospital operations and IT leader.
Cheryl Rucker-Whitaker, a physician executive and entrepreneur, is an  entrepreneur-in-residence at Health2047. She is the founder of Complete Care Management Partners LLC., a company that provides urban-based Medicaid focused delegate care management services to Fortune 100 payers. She is also a co-founder of NextLevel Health Partners, Inc.
Francis J. Crosson has 35 years of clinical and executive experience with Kaiser Permanente. He is founding Executive Director of The Permanente Federation—the national leadership and consulting organization for the 8 Permanente medical groups. He is also a past Group Vice-President of the AMA and immediate past Chairman of the Congressional Medicare Payment Advisory Commission (MedPAC).
Eric Yablonka is a practiced IT executive with over 30 years of experience in leading hospital operations and information systems management functions. He served as the Chief Information Officer at Stanford Health Care and the School of Medicine.
To read more, click here.
Picture: akindo, Getty Images

Remote patient monitoring implementation and reimbursement is a transformative development in healthcare. Although its robust adoption during the Covid-19 pandemic reflected the needs of the time, remote patient monitoring has many benefits that stand to make a significant difference in improving clinical practice workloads, chronic condition management, and the patient experience.
In a recent webinar sponsored by 100Plus, the health tech and medtech company provided a roadmap on how their program works, including device deployment, collaboration with clinicians to assess patient eligibility, as well as implementation and reimbursement.
Dr. Mintu Turakhia, a cardiac electrophysiologist, outcomes researcher, clinical trialist, and consulting head of medical at 100Plus, provided some background on the differences between the CMS program Chronic Condition Management and the more recent adoption of Remote Patient Monitoring.
CPT Code 99457 is a monthly billing code for Remote Patient Monitoring which reimburses providers for the direct expenses of remotely monitoring physiologic data while treating a patient. To qualify for reimbursement, clinicians and other healthcare professionals must provide at least 20 minutes of interactive patient care per calendar month. 100Plus facilitates interactive remote care with its patient clinician portal, making remote patient monitoring easy and accessible by bridging the gap between visits with consistent patient data.
Turakhia shared the findings of a clinical study by University of Pittsburgh Medical Center of patients with Type 2 diabetes who participated in a remote patient monitoring program with connected glucometers. The participants successfully reduced H1C levels.
He also highlighted a 100Plus study of 14,309 patients — 42% men and 58% women — who have Medicare. Topline results included a significant drop in blood pressure for patients with hypertension over 180 days and weight loss.
Turakhia also shared his outlook that although asynchronous care is here to stay, remote patient monitoring may change over time, as it adapts to the needs of practices and the government program’s evolution.
Mike Wurm, Director of Product and Strategy with 100Plus, provided an overview of how 100Plus helps practices onboard its RPM program. He pointed out that unlike many RPM programs that use Bluetooth, it chose to use SMS text/cellular data because no configuration is required since almost everyone has a phone that provides SMS texting. Wurm also noted that 100Plus can help determine which patients in a physician practice are eligible for RPM coverage. 
Patients receive devices that can transmit cellular data. The devices can include a blood pressure cuff, digital scale, blood glucose monitor, pulse oximeter, and a digital thermometer., . It also plans to add a spirometer. 
Patients interact with an engagement platform called Ava. The virtual, AI-based medical assistant prompts patients to use their devices to transmit physiologic data. The goal of the CMS RPM program is to provide a richer time series of clinical parameters upon which physicians can provision better preventive care to reduce reactive care such as hospitalizations and ER visits. 
Nadia Ziyadeh-Hammad, RPM Coordinator, at Greenville Healthcare Associates, which uses 100Plus, noted that the large screen and fonts on the devices made them easier to use for senior patients.  
She also related how an elderly patient who didn’t like to see the physician agreed to be monitored remotely and was helped by the platform. The physiologic data transmitted from the male patient’s devices indicated he had experienced some tachycardic events. When Nadia’s team followed up with the patients, he reported fatigue and chest pressure. They asked him to come in for an EKG and the data indicated the patient was close to having a cardiac event.
Although RPM has been available for 3 to 4 years, a new variation of the program, which CMS is currently piloting, is remote therapeutic monitoring, which focuses on pulmonary and musculoskeletal conditions. It includes five new RTM codes, all of which go live starting January 1, 2022. 
National Law Review cited this hypothetical examples of how the final rule could work in practice: 
An asthmatic patient is prescribed a rescue inhaler equipped with an FDA-approved medical device that monitors when the patient uses the inhaler, how many times during the day the patient uses the inhaler, how many puffs/doses the patient uses each time, and the pollen count and environmental factors that exist in the patient’s location at that time. This is non-physiologic data. The data is then used by the treating practitioner to assess the patient’s therapeutic response and adherence to the asthma treatment plan. This can enable the practitioner to better determine how well the patient is responding to the particular medication, what social or environmental factors affect the patient’s respiratory system status, and what changes could be made to improve the patient’s health.
In only two years, the RPM program has provided a gateway to wider adoption of virtual health tools. As we emerge from the pandemic with a greater comfort level for enlisting digital health tools in the care of patients with chronic conditions, it will be interesting to see how the CMS RPM program evolves and how 100Plus responds. To download the full webinar, please fill out the form below: