Guidance on Clinical Decision Support: Definitions and Transparency

The new FDA draft guidance for clinical decision support software is an important step forward but still has a long way to go.

Roughly two years after
we reviewed the first FDA guidance on Clinical Decision Support (CDS), FDA issued new draft guidance. The FDA was criticized for not basing their first draft regulation criteria on use-case risk. Since then the International Medical Device Regulators Forum (IMDRF), which the FDA chaired, created a framework for organizing Software as a Medical Device (SaMD) by risk categories. While CDS is a very broad category that encompasses many functions, this guidance could have an outsize impact on the need to provide transparency in AI/ML platforms and algorithms for healthcare.

ONC: More patients are downloading their medical records and using portals

The agency's analysis suggests increases in interoperability and patient-provider communication, along with frequent use of mobile health apps.

A brief out this month from the U.S. Office of the National Coordinator for Health IT found an increase in patient portal access and online medical record download rates over the past few years.  

In 2020, the agency said, about six in 10 individuals throughout the country were offered access to their patient portal, and nearly 40 percent accessed their record at least once.  

About a third of patient portal users downloaded their online medical record in 2020, nearly double the proportion of 2017.  

"Making it easier for individuals to access and use their electronic health information is a national priority," wrote agency representatives in the brief.   

NVIDIA In Healthcare: From Gaming To Medicine

Mostly renowned for its powerful graphics processing unit (GPU) used in the video game industry and, more recently, for crypto mining, NVIDIA is no stranger to healthcare. In fact, it has a dedicated branch to offer solutions that its computing platform can deliver in medicine. 

“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, told The Medical Futurist in an interview.

Prominently, 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 with the classification of images. In 2019, the tech giant also started to explore federated learning in healthcare, the privacy-focused A.I. training method. 

SDOH Strategies All Provider Organizations Should be Adopting Now

There is growing concern among many well-respected providers about the consequences of fewer preventive services over the past 1½ years as a result of the COVID-19 pandemic. As patients slowly start to resume care throughout 2021 and into 2022, experts predict we will see a spike in the number of severe or late-stage diagnoses that normally would have been caught much earlier. As a result, we may face more complex situations and costlier treatments in terms of their economic, physical, and mental health impact.

Cancer cases make an excellent illustration. People have not come in for recommended colonoscopies, mammograms, and other cancer screening exams during the pandemic. By the time they do, it is possible that any tumors found will be well established. Unsurprisingly but no less sadly, providers who have been resuming screenings are seeing more late-stage and terminal cancer cases.

Why outcome-based incentive models are critical to the success of VBHC

Successful transformation towards value-based health care (VBHC) involves a change to the organizational culture. This must be done inclusively, with a reward system and outcome-based incentive model that is focused on achieving a common goal: deliver the best health outcomes to patients.

In Part 2 of this interview, Christina Åkerman speaks to us about how to implement such an outcome-based incentive model to ensure the success of VBHC in your organization.

Click here to see Part 1 of this interview: Transforming towards VBHC and improving patient outcomes

Implementing an outcome-based incentive model

HT: You talk about rewards systems and outcome-based incentive models being key to the successful implementation of VBHC, how do you recommend that these models be created and who should be involved in their design?

Christina Åkerman: To me, the only way to design financial rewards systems for the long term is to base them on measuring and reporting health outcomes. This is a stepwise approach.

The first step is to move towards bundled payments as it is essential to integrate budgets across the entire care pathway. This way, you don’t have budgets for certain procedures or specialties.

How outcome-based contracting can improve access to innovative therapies

Apple looks to digital biomarkers for features detecting depression, cognitive decline

The Wall Street Journal reports that the work on the feature could be born out of collaborations with UCLA and Biogen.

Apple is looking to use digital biomarkers to help detect depression and early-stage cognitive decline, according to a new report out of The 
Wall Street Journal

The end goal, according to the Journal, is to create a new Apple feature that would tell users if there was a potential mental illness. Data collected regarding a users’ mobility, physical activity, sleep pattern could be included in the algorithm.

The report notes that the new effort could be tied to collaborations that the Silicon Valley titan already has established with UCLA researchers and pharma company Biogen. 

At the beginning of August UCLA announced a three-year study collaboration with Apple centered on finding the connection between depression and biomarkers collected by digital tools. In the study, researchers will look at data from the iPhone, Apple Watch and the Beddit sleep monitoring device. 

“This collaboration, which harnesses UCLA’s deep research expertise and Apple’s innovative technology, has the potential to transform behavioral health research and clinical care,” Dr. Nelson Freimer, a professor of psychiatry and principal investigator

Hospital at Home: Aligning Provider Needs with Patient Wishes

2020 saw three factors combine to define the future of “Hospital at Home” care in a way that will become a new care reality over the coming years.

Changing Patient Attitudes

Patients became more reluctant and concerned about going to hospitals. The fear of contracting illnesses such as Healthcare Acquired Infections (HAIs), like sepsis, is a real and legitimate concern. While the number of patients has been declining, around 100,000 people die each year in the US from contracting an HAI in the hospital setting. To top it all off, the risk of contracting an infection increases with the length of time spent in the hospital facility.

Ponemon study finds link between ransomware, increased mortality rate

Researchers surveyed nearly 600 health IT and security professionals about the ways cyberattacks disrupt care delivery and put patient safety at risk.

A report released Wednesday by the Ponemon Institute found that ransomware attacks in the time of COVID-19 have had an impact on patient safety, data and overall care availability.  

For the report, sponsored by the risk management platform vendor Censinet, Ponemon surveyed nearly 600 IT and security professionals in healthcare delivery organizations.

"Our findings correlated increasing cyberattacks, especially ransomware, with negative effects on patient care, exacerbated by the impact of COVID on healthcare providers," said Dr. Larry Ponemon, chairman and founder of the Ponemon Institute, in a statement. 

"We also analyzed steps that HDOs are taking to protect patient safety, data and care operations to determine what is working since so many respondents have been victims of more than one ransomware attack," Ponemon said.  

AI development must be guided by ethics, human wellbeing and responsible innovation

Need for Speed in Medical Device Innovation

October is Breast Cancer Awareness Month. In recognition of this awareness month, we are highlighting Innovative companies, like KUBTEC, that continue to challenge the status quo of breast cancer.

By John Pizzonia, Research and Development Manager, KUBTEC Medical Imaging
Twitter: @Kubtec

Post-pandemic, Medical Device Companies Need to Reimagine Approach to Accelerating Innovation

After spending more than 20 years of my career in R&D with leading medical device and life sciences companies, it’s no secret to me that speed matters when it comes to product development and go-to-market. Still, amid the pandemic, speed has taken on a whole new meaning.

In order to step up and meet growing demands from consumers, industry, and business leaders, medical device companies need to reimagine their approach to accelerating innovation. To do so, medical device companies should consider focusing on three critical best practices.

Many top health systems still behind on digital patient access, report finds

Though the pandemic has accelerated health organizations’ digital initiatives, the race to keep up with patient preferences continues to be challenging for many top-ranked hospitals, a new analysis from Kyruus finds.

The health tech company assessed the top 20 hospitals in the U.S. according to the latest U.S. News & World Report rankings. It looked at four categories—consumer engagement tools, an easy and modern search experience, consumer-centric filtering options and self-service booking capabilities—to determine areas of strength and opportunities for improvement when it comes to digital patient access and engagement.

Overall, hospitals need to focus more on the end-to-end consumer experience, with the ability to find care online, book an appointment and prepare for it with ease, according to the analysis.

Only one-quarter of health systems have virtual assistants or chatbots, Kyruus found, though they are considered highly helpful to patients. More than half display clear and embedded calls to action that prompt consumers to do things like book appointments online or call a number to schedule one. While many also have mobile apps for existing patients, just over a third have apps through which new patients can find or schedule care without creating an account.

Enhancing the Digital Patient Experience at Texas Children’s Hospital

There’s nothing better than learning about enhancing the digital patient experience than to hear from people who have been on the front lines doing it.  As part of the Healthcare Analytics Summit 21 Virtual Event put on by Health Catalyst, attendees got to hear from Carrie Rys, MBA, Assistant Vice President, Pediatrics Administration, and Grace Karon, Assistant Director, Business Operations and Strategic Planning from Texas Children’s Hospital.  In their session, Rys and Karon share how they used digital technologies and change management efforts to improve the patient experience.

Given their success in now having over 1 million appointments scheduled online, we wanted to share how they were able to achieve such incredible results.  In this interview with Colin Hung, Rys and Karon share what’s made their efforts to enhance the digital patient experience a success.  They address some of the technology, education, and process changes that were needed to accomplish their goals.  This included really having this as an institutional goal that everyone was working towards.

Why patient-centred digital systems are revolutionising healthcare?

4 Best Practices to Deliver Virtual Palliative Care for Providers

More and more people are living with serious illnesses such as cancer, heart failure, chronic obstructive pulmonary disease and liver disease. The National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) reports that 60 percent of U.S. adults have a chronic disease, which is the leading cause of death and disability and the leading driver of healthcare costs.

Palliative care is well-positioned to meet the unique needs of seriously ill individuals by helping to deliver relief from the symptoms and stresses of chronic illness and improving the quality of life for those in care and their loved ones. In contrast with the more widely known hospice care, which provides compassionate care for those diagnosed with terminal conditions, palliative care can be combined with curative treatment and is applicable at any stage in a serious illness. Palliative care reduces emergency department utilization, decreases visits to costly and unwanted acute care hospital services and improves the healthcare experience.

HHS Announces Synthetic Health Data Challenge Winners

The U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) today announced $100,000 in total awards to six winners of the Synthetic Health Data Challenge (Challenge). Synthetic health data (i.e., data that is artificially created to mimic real-world data), is important to researchers, health IT developers, and informaticians, among others, who need data to test new ideas until access to secure and actual clinical data is available.

The Challenge was conducted under ONC's Synthetic Health Data Generation to Accelerate Patient-Centered Outcomes Research (PCOR) project, which is supported by HHS' Office of the Secretary Patient-Centered Outcomes Research Trust Fund. Challenge winners created and tested innovative and novel solutions that will further augment the capabilities of Synthea™, an open-source synthetic health data generator that models the medical histories of synthetic patients. The availability of reliable and robust synthetic data generation tools safeguard patient privacy because they support appropriate stewardship practices in which real patient data is only accessed and used when necessary.

"The availability of realistic, synthetic data is a vital part of supporting iterative testing models and early stage research and product development," said Steve Posnack, deputy national coordinator for health information technology. "We received a lot of inspired submissions that took this work to the next level and hope that each winner can serve as a foundation to further enhance tools that create synthetic data."

The Synthetic Health Data Challenge winning solutions are:

Diffusion of Excellence: Accelerating the Spread of Clinical Innovation and Best Practices across the Nation’s Largest Health System