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By Viviente Health Health Lifestyle News

02 Dec: How Patient Care Is Being Improved by Technology Everyday

With technology becoming more integral to patient care in recent years, innovation in the medtech space is progressing at an unprecedented level. From streamlining long-held manual processes to creating entirely new diagnostic devices, new tech is cropping up all over the industry—resulting in a real-world impact on patients’ quality of life.
These technologies are helping companies to enable faster and more efficient engagement with patients, improve traditional devices, incorporate more software solutions into patient care, and even launch wholly new products. Further, these modern tools help medtech companies keep up with the rapid pace of innovation, by launching new products faster and quickly extending to new markets.
Streamlining quality processes for the better
In medtech especially, quality is the name of the game. The speed at which companies can address post-market or field issues is vital to success. After all, if a product meant to improve patient care isn’t performing the way it’s intended to, there could be tangible life-saving implications.
The secret to speedy post-market action is automating and integrating what was once a manual and disparate case-to-complaint and reportability process, by using a single enterprise platform.
For instance, imagine a company that wants to decrease their issue-to-resolution times. Their cases can be automatically tied to complaints and propagate common data, enabling faster investigations, reportability determination and electronic submissions.
Also, their enterprise technology enables them to capture nonconformances with batch details which can quickly trigger ship holds, dispositions, and field actions.
And many of these major innovations trickle downstream to corrective and preventive actions (CAPA), Engineering Change Orders (ECOs), and business processes.
Having the ability to close the quality loop throughout the entire enterprise value chain can not only revolutionize a necessary process, it can deliver better patient experiences and outcomes.
Improving traditional therapies 
While headlines about new strains of Covid-19 and Monkeypox continue to circulate, the most common chronic diseases continue to grow at alarming rates.
Technology is helping to both manage difficult symptoms of these diseases, and find proactive ways to prevent them before the onset.
Advances in technology are giving patients their independence back. Think of how much easier a diabetes patient’s day-to-day life would be by conducting therapies in their own home instead of adjusting their scheduling around trips to the hospital for recurring appointments. Not to mention the lowered cost.
Imagine a world where therapies for type 2 diabetes (T2D) have the potential to prevent or even reverse its course. In the U.S. alone approximately 30 million people are diagnosed with T2D and half of them have difficulty controlling it.
Leveraging software as a medical device (SaMD)
Smart technology is virtually inescapable today. We use software devices in many aspects of our lives—in our homes, in our cars, in our pockets. And our medical needs are no exception.
Software as a Medical Device (SaMD) is one of the fastest growing areas of medtech innovation, enabling tangible life-saving results from:

Remote patient monitoring Faster, more accurate disease diagnosis and treatment decisions, such as stroke and pulmonary issues
Streamlined workflows & coordination for care teams
Digital Therapeutics and Digital Companions

…and the list is increasing exponentially. SaMD has changed how patients manage their health and interact with healthcare professionals.
Ushering in the future of care
The pace of medtech innovation is accelerating so much it almost feels as if we’ve stepped into the future. There are groundbreaking companies focused on eradicating certain cancers that are offering comprehensive genomic profiling (CGP) which provides results from a simple blood draw in days. This allows oncologists to obtain information quicker and advise the right treatment to each of their cancer patients.
This is just one example of how patients at all stages of cancer can live longer and healthier through the power of blood tests and the data they unlock.
The secret weapon 
The secret weapon is the ability to connect all business processes on a single platform solution. Keeping pace with top innovators requires a modern system to manage integrated change processes and cross-functional collaboration across the entire product and software lifecycle.
The critical and complex products that patients rely upon demand responsibility to ensure the best availability, quality, outcomes and uptime.
Photo: metamorworks, Getty Images

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By Viviente Health News

02 Dec: The FDA Is Opening the Use of Registry Data in Drug Development – What Does It Mean for Patient Advocacy Groups?

Having a full view of a patient’s health story through real-world data (RWD) and evidence (RWE) is the key to improving health outcomes and advancing treatment options. Yet, many historical challenges have slowed consistent adoption, such as data standards, data holders disregarding and blocking the sharing of information, and a lack of awareness among a broader population. In response, the 21st Century Cures Act in 2016 prompted government agencies such as the Center for Medicare and Medicaid Services (CMS), the Office of the National Coordinator for Health IT (ONC), and the Federal Drug Administration (FDA) to publish regulations and guidance to address these issues.
Since then, industry stakeholders have increased their understanding of the importance of electronic health data, including patient registries, in the clinical care and research process. In tandem, patient registries have been exploring how to become strong industry partners by providing the data needed to improve the treatments available to their patient communities. The recent draft guidances released by the FDA in late 2021 and early 2022 offer broad recommendations for using real-world evidence in drug development.
While these draft guidances do not provide strict requirements for industry stakeholders to abide by, they offer patient advocacy organizations with a clearer understanding of how to model their registries to have a more substantial impact for their patient communities.
Guidance: Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry
What is in this draft guidance?
To successfully utilize registry data in drug submissions, the FDA released this draft guidance to provide recommendations on evaluating the relevance and reliability of a potential registry partner. Also included are several considerations for linking registry data to other sources to provide supplemental information, including EHRs, digital health technologies, and other registries.
How does this impact patient advocacy organizations?
This draft guidance is the exemplary roadmap for how patient advocacy organizations should model their registries to build industry partnerships and maintain relevance. The key features that the FDA recommends include relevance of the registry data for a given study, the reliability of the registry data information and quality, and the ability of the registry data to be linked with other systems. Patient advocacy organizations should implement these recommendations now to ensure success long term.
Guidance: Considerations for the Use of Real-World Data and Real- World Evidence to Support Regulatory Decision-Making for Drug and Biological Products
What is in this draft guidance?
In this draft guidance, the FDA outlined the best practices for the use of RWD for investigational new indication of drug (IND) applications. Research for INDs aim to gain approval for new uses of existing drugs (i.e., a drug for epilepsy being approved for alternative use to treat migraines). Best practices outlined in this guidance include clear documentation on all the data analyses performed during the study design phase when submitting the application to the FDA.
How does this impact patient advocacy organizations?
Through this draft guidance, patient advocacy organizations will be able to play a major role in advancing IND studies as a trusted data source. Historically, some of the biggest treatment advancements for many disease groups have come from utilizing drugs that are already established. By supporting the IND process, patient advocacy organizations have new opportunities to achieve their core mission of finding better treatments for their patient communities. Getting involved with IND studies is also a way for patient advocacy organizations with strong registry data to strengthen business sustainability.
Guidance: Data Standards for Drug and Biological Product Submissions Containing Real-World Data
What is in this draft guidance?
The FDA suggests that all RWD, including EHR and registries, that is submitted for review and approvals should be in a standard electronic format. This draft guidance outlines the necessary standards that industry stakeholders must comply with when submitting any study data that includes RWD. While the FDA acknowledges that there is a wide range of approaches to data transformation, they will require detailed documentation and the rationale behind the specific approach used.
How does this impact patient advocacy organizations?
The purpose of this draft guidance is to promote the ease of interoperability (i.e., the sharing of data) by creating compatibility standard. The ability to bring together insights from multiple sources helps provide valuable insights to patients, clinicians, and researchers, about the manifestation of different diseases. This is important to patient advocacy organizations because it empowers their patient communities to make more informed decisions about their health and increases the likelihood of successful treatment development.
Guidance: Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
What is in this draft guidance?
The FDA goal with this draft guidance is to provide recommendations for appropriate study designs using RWD sources prior to submission to the agency for approval. By outlining study design considerations, the FDA is aiming to ensure the safety and efficacy of drugs submitted for approval, including data source relevance and validity of data sources.
How does this impact patient advocacy organizations?
The fundamental aim of this draft guidance is ensuring drugs endorsed by the FDA improve health outcomes while also reducing the risk of potentially life-threatening side effects. By encouraging researchers to submit EHRs and registry data directly to the FDA, it will reduce provider burden and help with site recruitment and retention. Improved site recruitment and retention is important to patient advocacy organizations because it is vital to successful treatment advancements for their patient communities.
Overall takeaways for patient advocacy organizations
These guidances provide patient advocacy organizations with the opportunity to increase their influence in advancing drug developments that will keep patients at the center of the conversation. Because these draft guidances are recommendations, not requirements, the FDA is sending a signal to stakeholders that they are open to continuing a dialogue on key priorities.
When it comes to next steps for organizations, creating a systematic strategy that incorporates all data handling best practices that the FDA lays out in these draft guidances, will be critical. This includes cross-checking registry data against the ONC’s USCDI requirements for interoperability and providing clear documentation about the relevance and reliability of the data for a stakeholder’s specific goals. Reducing the burden on stakeholders and establishing trust in the value of an organization’s registry will be the key to sustainability and advancing treatment options for their patient communities.
Photo: Getty Images, Sarah Silbiger

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By Viviente Health News

01 Dec: Why UNC Chose AWS as Its Cloud Partner to Launch 10 Startups Over 3 Years

The innovation institute run by the University of North Carolina at Chapel Hill teamed up with Amazon Web Services on Wednesday to create a venture studio to turn the university’s digital health research concepts into full-fledged startups. AWS’ platform beat out the other major cloud providers because it was “the most entrepreneurial,” according to Bob Dieterle, the venture studio’s managing director.
Dieterle helped create the venture studio because he noticed something important: despite the fact that universities produce plenty of valuable digital health research, they often fail to commercialize digital health products in the form of modern app technology. 
Universities need a better pipeline model to quickly turn research into cloud-based digital health apps, he said in an interview.
The collaboration will support 25 concept development projects over three years. Refining the venture concept and validating technology may take longer than three years for some projects, so the collaboration has a goal of launching 10 startups during that time period, Dieterle said in an interview.
UNC and AWS are selecting projects that improve healthcare access, patient outcomes and the patient and provider experience. UNC researchers whose projects are selected will receive guidance from AWS software developers who specialize in cybersecurity, computing, biomedical research, and healthcare machine learning. 
There are five types of projects the collaboration is looking to support: platforms to help providers better run their enterprises, platforms to help clinicians and clinical support staff, products that store and transmit clinical information to guide care, products that aid in the diagnosis or monitoring of patients, and medical interventions or therapies.
UNC researchers will collaborate with experts from AWS at UNC-Chapel Hill’s health research labs. They can use the research labs’ software building platform to build their concepts into production-ready models to run on AWS.
When choosing a cloud partner for this venture studio, UNC looked at other major cloud providers, including Google, Microsoft and Oracle, according to Dieterle. He said UNC went with AWS because it was the company that demonstrated the most commitment to building a new type of cloud-based pipeline to commercialize more digital health research from universities.
“We need a new model than what is currently being done,” Dieterle said. “If you look at the big tech companies, they’re very siloed. They have a public sector team, and all they care about is selling to a university, for example. Then they have a startups team. These teams don’t necessarily work together. And then the startups team will wait for a university startup to be spun out, and then they engage with them. And they have innovation programs — and these programs, disparately, really don’t work. We need to identify a pipeline.”
Under this pipeline model, researchers can access cloud-based software and data science tools to help them validate their algorithms sooner — and hopefully get to commercialization sooner.
AWS was the cloud provider who demonstrated the most enthusiasm about this pipeline model, according to Dieterle. He said AWS brought together its public sector team, startup team and research team together into one and worked with UNC to create a single concept development process.
“I tried to do this with the others, and they weren’t really very interested in doing that. So that’s how we settled on Amazon,” Dieterle said.
Eight of the collaboration’s 25 planned projects have already kicked off. As startups begin to be launched out of the venture studio, UNC will share upside with them. For example, UNC will financially benefit when startups license the technology that was developed at the university. UNC is also becoming investors in these companies and getting on their capital tables, according to Dieterle.
Photo: Eva Almqvist, Getty Images

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By Viviente Health Lifestyle News

01 Dec: Federal Court Says Cerner May be on the Hook in Brain Damage Lawsuit

Medical software company Cerner must head to trial for a jury to decide whether its software contained design defects that caused brain damage to a 25-year-old who was undergoing surgery to remove his gallbladder.
In a 2-1 decision, the Fourth Circuit said that the lower court, the Eastern District of Virginia, erred when it sided with Cerner and granted the company summary judgement.
“On the record before us, a jury reasonably could conclude that Cerner’s software contained two design defects that did not comply with industry standards or satisfy reasonable consumer expectations,” Senior Circuit Judge Barbara Milano Keenan stated in the opinion published Tuesday in a decision from the Fourth Circuit Court of Appeals. 
Cerner, based in Arlington, Virgina, develops and sells a software system that hospital staff use to enter medical orders for patient care.
The case started when Ruby Lowe, grandmother of patient Michael Taylor, filed a lawsuit against Cerner in 2019 on behalf of her grandson. In seeking $50 million in damages, Lowe alleged that there were two design defects in Cerner’s software and that the company failed to warn users of those defects.  
As described in the opinion, Lowe maintains that those alleged defects affected the doctor’s orders. The doctor’s orders were supposed to show that pulse oximetry should start immediately after the surgery but instead showed to start pulse oximetry at 10:00 a.m. the day after Taylor’s surgery.
Lowe contends that when the doctor — Alexandria Booth — performed surgery on Taylor at Virginia Hospital Center, she put in an order for him to receive continuous pulse oximetry to measure the oxygen levels in his blood. A pulse oximeter will send an alarm to alert hospital staff when a patient’s oxygen drops below a certain level so the staff can wake the patient. 
However, Taylor’s oxygen levels were not monitored overnight and he suffered from hypoxia, or a lack of oxygen to his brain, causing damage. As a result, Taylor can no longer walk, bathe, or use the bathroom by himself. 
“The parties do not dispute that if Taylor’s oxygen level had been monitored continuously, his resulting hypoxia and brain damage would not have occurred,” Keenan wrote in the opinion.
The question is who is at fault. And the Court of Appeals believes it’s possible to point the finger at Cerner. 
In his dissent, Judge James Harvie Wilkinson wrote that because Taylor’s grandmother already reached a settlement with the hospital where the procedure was performed — Virginia Hospital Center — and with the doctor’s employer, the case seems to be about money only. 
“There is one reason, and one reason only, that the manufacturer is a defendant in this suit. It has a deep pocket,” Wilkinson wrote. 
He said that Lowe has failed to show that Cerner’s software was a probable cause for the brain damage Taylor suffered. He says that hospital staff are to blame for the tragedy that occurred. 
Lawyers for Lowe and for Cerner did not immediately respond to requests for comment. 
Photo: AndreyPopov, Getty Images

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By Viviente Health Health Lifestyle News

01 Dec: AHIP: Americans Want Congress To Make Telehealth Capabilities Permanent

To address challenges during the Covid-19 pandemic, state and federal governments provided temporary waivers and flexibilities to make telehealth more available for consumers. Now, Americans want the government to make these provisions permanent, a new survey shows.
The survey was published Thursday by advocacy group America’s Health Insurance Plans (AHIP). It was fielded in October by NORC at the University of Chicago and included a nationally representative sample of 1,000 adults, of which 498 were commercially insured.
AHIP’s survey found that 73% of commercially-insured telehealth users think that “Congress should make permanent the provisions that allowed for coverage of telehealth services before paying their full deductible.” 
Because of these findings, “health insurance providers encourage policymakers at the federal and state levels to make telehealth design flexibilities permanent to allow for the continued convenience, access, and value they provide for Americans,” the advocacy organization stated in a news release. 
The survey also discovered:

Four in 10 of the commercially insured respondents said they had used telehealth in the last year. Of this group, more than half used telehealth between 2 to 5 times in the past year.
Nearly 70% of commercially-insured telehealth users said they used telehealth instead of in-person services in the last year because of convenience.
Almost 4 in 5 commercially-insured telehealth users said telehealth helped them receive care when they needed it.
Another 85% said there is an “adequate” number of providers available through telehealth to meet their health needs.
Women with commercial insurance were 1.6 times more likely than men to use telehealth services. Women were also four times more likely than men to use telehealth due to a lack of childcare or eldercare.
Those with low to middle incomes use telehealth slightly more than those with higher income. About 40% of those earning $30,000-60,000 annually and 46% of those earning $60,000-100,000 annually use telehealth, compared to 38% of those earning more than $100,000.

“Patients and providers accept — and often prefer — digital technologies as an essential part of healthcare delivery,” Jeanette Thornton, executive vice president of policy and strategy at AHIP, said in the news release. “Telehealth can be just as effective as in-person care for many conditions and allows patients to receive more services ‘where they are.’ That’s why health insurance providers are committed to strengthening and improving both access and use for the millions of Americans who use telehealth for their health care needs.”
Photo: Alisa Zahoruiko, Getty Images

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01 Dec: UpStream Rakes In $140M to Scale VBC for Seniors

UpStream — a company that provides care coordination technology and services for physicians enrolled in value-based care models — raised $140 million in Series B financing on Thursday. 
The round brings the Greensboro, N.C.-based company’s total funding to nearly $185 million to date. It was co-led by investment firms Coatue and Dragoneer, with participation from Avidity Partners, Define Ventures and Mubadala.      
UpStream was founded in 2018 by pharmacist and entrepreneur Fergus Hoban.
“[Hoban] was deeply cognizant of the challenges of the broken healthcare system — mainly the fact that patients who were living with chronic conditions and medically complex conditions really got the shortest end of the stick in primary care practices. They were shuffled between specialists in primary care. And due to their medical complexity, they did not fit into the conventional time slot of a 15 to 20 minute primary care visit,”  UpStream CEO Sanjay Doddamani said in an interview.
UpStream’s mission is to address the fact that patients with chronic conditions often do not receive an appropriate level of care — a reality that often sends them to emergency departments and hospitals. Many of these admissions could be avoided if patients received the right care earlier, Doddamani said.
To solve this problem, UpStream provides primary care practices with AI-based technology designed to anticipate patient needs and coordinate care for patients living with chronic conditions. The company also deploys pharmacist-led care teams into primary care practices. These teams are meant to bring all of a patient’s challenges “under one umbrella,” from managing multiple prescriptions to coordinating transportation to appointments, he said.
These pharmacist-led care teams are meant to make patients feel more comfortable and less rushed in the U.S. healthcare system. Doddamani claimed that this approach involving pharmacists is one of the factors that differentiates UpStream from its competitors, such as Oak Street Health, Agilon Health and Privia Health.
Another factor is the fact that UpStream takes on full financial risk with payers to enable physicians to deliver value-based care to seniors, who are often the most complex and expensive patients to care for, Doddamani pointed out.
The company doesn’t charge providers to use its services. While it gets to share in savings, UpStream is also accountable for some of the loss if spending goes beyond the benchmark. The company has negotiated rates with Medicare programs and takes on both upside and downside risk — but physicians “only see the upside” because they get paid by UpStream no matter what, according to Doddamani. 
“We have to put up capital reserves to participate in these models,” he said. “And then based on savings, we get paid. Our physicians also get paid based on savings. But the way we’ve constructed our model, our physicians don’t wait to get paid.”
UpStream works with physicians who provide care to seniors on Medicare under full-risk, value-based arrangements. Some of these physicians are independent, and others are attached to a larger network or healthcare system. 
The company has partnered with physician groups in North Carolina, Virginia and South Carolina.
For next year, UpStream has announced new partnerships with Community Care Physician Network in North Carolina, Tidewater Medical Group in Virginia, Primary Care Associates in South Carolina, and Medical University of South Carolina Health Alliance.
“We have enabled the primary care physician to enter into a domain of full financial risk,” Doddamani said. “They can have maximum opportunity for that boat financially — but also more importantly, for resource-rich environments to be able to deliver better care for their older, sicker patients right in the existing primary care infrastructure. How can they do that? Because we put in the vital resources that they need — not just the technology, but also the people.”
Directly embedding a pharmacist in primary care offices to manage prescriptions is a key way UpStream does this. Providing patients with home-based support, such as field nurses and a medical support concierge, is another way.
UpStream’s internal data shows that when patients are supported by their services, their cost of care ends up decreasing by an average of 20%, according to Doddamani. This mostly comes from annual reductions in hospitalizations and emergency department visits, he said.
“We don’t stand in the way of patients or act as a barrier to their aspirations for something like elective surgeries when appropriate — it is really about reducing the avoidable suffering that patients are confronting by having to repeatedly go into the hospital for one of their underlying chronic conditions,” Doddamani said.
Photo: Doug Burke Photography

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