Wednesday, October 14, 2020

Israeli drone company plans for worldwide aerial-supply networks |



Gadfin, or “wings” in Aramaic
Its flagship aircraft hovers like a UAV and folds out wings to fly like a plane—is hoping to connect Israeli hospitals with drone supply networks and has its sights set on providing essential services in remote Third World locations.

Israel’s Gadfin UAVs (Unmanned Aerial Vehicle) and drone producer was the first company in the world to receive the Israeli Civil Aviation Authority permit for urban airspace deliveries this year. That permit means that Gadfin can compete for tenders that provide a glimpse into the near future. Under this vision, hospitals, laboratories, and a range of organizations will send and receive supplies via drone transport networks, skipping over-congested roads and reducing risk to sensitive, refrigerated packages.

Gadfin holds several breakthrough patents, including for a first of its kind drone called “Spirit One” that folds out its wings in-flight. It can take packages weighing up to 15 kilograms across more than 250 kilometers. The aircraft are operated autonomously with almost no human intervention.

The company is also designing a larger version of “Spirit One,” called “Spirit X,” which can take 100-kilogram packages across 500 kilometers.

Spirit One

The use of drones requires electrification of it's engine(s) and the use of GPS, possibly 5G and integration of air traffic control systems for optimization and safety concerns.  Modern air control systems will have to adapt to new flight modes.

Gadfin CEO Eyal Regev states,

“When we look at the world, we see that most areas are in the periphery. Most peripheral areas are very much lacking the services that city centers enjoy. It’s true for Southeast Asia, it’s true for Africa, it’s true for South America, but also for the West. This applies to many services. Medical tests, for example, have short lifespans and need to reach destinations quickly,” he explained.

“We hope that within two years, we can connect Israeli hospitals. This could speed up deliveries of sensitive medical supplies like bone marrow transplants. These are highly complex and expensive deliveries on land,” said Regev. “Instead of having doctors or nurses accompany the delivery to make sure the taxi doesn’t stop in the sun, our aircraft whisks them to the lab or hospital in minutes.”

The marketplace is expanding for drones in health care.  It is also apparent that the new niche will have many competitors looking for business.









‘This is a revolution’: Israeli drone company plans for worldwide aerial-supply networks | JNS.org

Sunday, October 11, 2020

In Treating Alcohol Use Disorder, Gender Matters | by Phillip Levin

                                

These days, talking about the differences between men and women can be perilous. The subject is a polarizing one and for a good reason.

One has to wonder, what can be gained of acknowledging our differences?

However, there is one area where such discussion may have great utility: medicine.

There are biological differences between the sexes, and when it comes to medicine, these such differences may be too important to ignore.

Take, for example, Alcohol Use Disorder. Researchers at the Boston University School of Medicine published a study recently that indicates significant differences exist in the neuropathology of Alcohol Use Disorder in men and women.

In the study, researchers found that brain activity in regions associated with the processing of memories, emotion, and socialization are more significantly reduced in men diagnosed with alcoholism than men who are not alcoholics. Meanwhile, researchers found increased brain activity in women alcoholics compared to women who are not alcoholics.

Admittedly, such findings come with the potential to provide power to those who want to endorse gender stereotypes. But equally so, findings like this present an opportunity to better understand an affliction that causes real harm and suffering to anyone hurt by this substance use disorder — a cause that is important to many, independent of gender.

Previous research had indicated that there may be abnormalities in how the brains of alcoholics process “aversive stimuli” associated with “negative feelings, such as fear, pain, and stress,” according to the neuroscientists responsible for the study. This differential response could be implicated in the likelihood of developing Alcoholic Use Disorder as well as the relapse of recovering alcoholics.

These researchers were willing to ask an important but perhaps controversial question: what’s the difference between men and women?

In an effort to better understand how alcoholism affects the brains of men and women, researchers used functional magnetic resonance imaging (fMRI) to monitor the brain’s response to emotional stimuli. Alcoholic and non-alcoholic men were compared separately, while alcoholic and non-alcoholic women were also compared.

In both cases, the neuroscientists showed study participants variety of images expected to invoke a particular type of emotion. Specifically, images with salience related to erotic, fixation, neutral, happy, aversive, gruesome feelings were used. The researchers then measured the activity of different brain regions to determine if men and women’s brains were affected differently by Alcoholic Use Disorder.

The study’s findings suggest they are.

The researchers found diminished brain activity in alcoholic men in response to having seen emotional and neutral images. In particular, the reduced brain activity occurred in the inferior parietal gyrus, anterior cingulate gyrus, and postcentral gyrus. The experiment revealed that there was significantly lower activation of brain regions, such frontal, parietal, and temporal regions,in alcoholic men across the different types of emotional stimuli. According to the researchers, this may indicate “deficits” in “maintaining positive and negative emotions.”

In alcoholic men, the inferior parietal cortex also showed a diminished response. This brain region processes the “perception of emotions in facial stimuli.” Most of the images shown to the subjects contained faces, according to the researchers, so this reduced response “may represent an impairment in processing emotional facial expressions” for men with Alcohol Use Disorder. Additionally, the limbic and subcortical structures of men with the disorder responded similarly to both erotic and neutral pictures. This is surprising, given that these brain regions in non-alcoholic men typically respond differently to such types of images.

Interestingly, the researchers found that the brain activity of women was increased in different areas than in men, including the superior frontal and supramarginal cortex. Meanwhile, in alcoholic women, the superior frontal cortexhad an increased response to happy stimuli and supramarginal gyrus an increased response to aversive stimuli. This, according to the scientists, may suggest “possible compensation for deficiency in maintaining positive and negative emotions.” The difference in the limbic and subcortical response of alcoholic women’s brains to erotic and neutral pictures was increased, indicating an increased emotional response in women with Alcohol Use Disorder.

From a scientific standpoint, such differences are interesting. However, it is necessary that findings like these are delivered with a careful awareness about the implications and repercussions of such ideas should they be misconstrued or wrongly characterized by those with malicious intent for society.

One must actively circumvent the wrong ideas here. Medical discoveries about the differences between the sexes are not statements about the value of either sex. This is a discovery about a disease and information about how to proceed with future medical interventions.

The important thing here is not that men and women with Alcohol Use Disorder are different. Rather, it’s that treatment plans can be improved, perhaps, by understanding the details of the pathology, including the effect of sex differences.

If knowledge of biological differences between men and women can lead to better treatment plans, should we not acknowledge and employ such information in developing treatments?

It seems that such distinctions might, at the very least, be beneficial in developing treatment plans to help the more than 100-million people worldwide who are suspected of struggling with Alcohol Use Disorder.

Phillip Levin

WRITTEN BY

Phillip Levin

Theoretical physics graduate student @ Cal State LA. Alumni @ UC San Diego. Editor of online physics textbook, https://www.didacticful.com.








In Treating Alcohol Use Disorder, Gender Matters | by Phillip Levin | Medium

Wednesday, September 30, 2020

Back to the Future: Trump’s History of Promising a Health Plan That Never Comes

 

Back to the Future: Trump’s History of Promising a Health Plan That Never Comes

Last night's Presidential Debate produced nothing....chaos and empty promises.

Ever since he was a presidential candidate, President Donald Trump has been promising the American people a “terrific,” “phenomenal” and “fantastic” new health care plan to replace the Affordable Care Act.

But, in the 3½ years since he set up shop in the Oval Office, he has yet to deliver.

In his early days on the campaign trail, circa 2015, he said on CNN he would repeal Obamacare and replace it with “something terrific,” and on Sean Hannity’s radio show he said the replacement would be “something great.” Fast-forward to 2020. Trump has promised an Obamacare replacement plan five times so far this year. And the plan is always said to be just a few weeks away.

The United States is also in the grips of the COVID-19 pandemic, which has resulted in more than 163,000 U.S. deaths. KFF estimates that 27 million Americans could potentially lose their employer-sponsored insurance and become uninsured following their job loss due to the pandemic. (KHN is an editorially independent program of the Kaiser Family Foundation.) All of this makes health care a hot topic during the 2020 election.

This record is by no means a comprehensive list, but here are some of the many instances when Trump promised a new health plan was coming soon.

2016: The Campaign Trail

Trump tweeted in February that he would immediately repeal and replace Obamacare and that his plan would save money and result in better health care.

By March, a blueprint, “Healthcare Reform to Make America Great Again,” was posted on his campaign website. It echoed popular GOP talking points but was skimpy on details.

During his speech accepting the Republican nomination in July, Trump again promised to repeal Obamacare and alluded to ways his replacement would be better. And, by October, Trump promised that within his first 100 days in office he would repeal and replace Obamacare. During his final week of campaigning, he suggested asking Congress to come in for a special session to repeal the health care law quickly.

2017: The First Year in Office

January and February:

Trump told The Washington Post in a January interview that he was close to completing his health care plan and that he wanted to provide “insurance for everybody.”

He tweeted Feb. 17 that while Democrats were delaying Senate confirmation of Tom Price, his pick to lead the Department of Health and Human Services, the “repeal and replacement of ObamaCare is moving fast!”

And, on Feb. 28, in his joint address to Congress, Trump discussed his vision for replacing Obamacare. “The way to make health insurance available to everyone is to lower the cost of health insurance, and that is what we are going to do,” he said.

March: Eyes on Congress — And Twitter

House Republicans, with backing from the White House, were the ones to introduce new health legislation, the American Health Care Act (AHCA). The repeal-and-replace bill kept in place some of the more popular provisions of the ACA. Some conservative Republicans said the bill didn’t go far enough, deriding it as “Obamacare Lite” and refusing to vote on it.

On March 9, Trump tweeted, “Despite what you hear in the press, healthcare is coming along great. We are talking to many groups and it will end in a beautiful picture!”

Later that month, as efforts to pass the AHCA continued to stall, Trump updated his earlier promise.

“And I never said — I guess I’m here, what, 64 days? I never said repeal and replace Obamacare. You’ve all heard my speeches. I never said repeal it and replace it within 64 days. I have a long time,” said Trump in his remarks from the Oval Office on March 24. (Which was true; he had said within 100 days.) “But I want to have a great health care bill and plan, and we will. It will happen. And it won’t be in the very distant future.”

April and May: A Roller-Coaster Ride of Legislation and Celebration, Then …

After an intraparty dust-up, the House narrowly passed the AHCA on May 4. Despite tepid support in the Republican-controlled Senate, Trump convened a Rose Garden celebratory event to mark the House’s passage, saying he felt “so confident” about the measure. He also congratulated Republican lawmakers on what he termed “a great plan” and “incredibly well-crafted.”

Nonetheless, Senate Republicans first advanced their own replacement bill, the Better Care Reconciliation Act, but ultimately voted on a “skinny repeal” that would have eliminated the employer mandate and given broad authority to states to repeal sections of the ACA. It failed to gain passage when Sen. John McCain (R-Ariz.) gave it a historic thumbs-down in the wee hours of July 28.

September and October: Moving On … But Not

Trump began September by signaling in a series of tweets that he was moving on from health reform.

But on Oct. 12, he signed an executive order allowing for health care plans to be sold that don’t meet the regulatory standards set up in the Affordable Care Act. The next day, Trump tweeted, “ObamaCare is a broken mess. Piece by piece we will now begin the process of giving America the great HealthCare it deserves!”

Roughly two weeks later, on Oct. 29, Trump got back to the promise with this tweet: “… we will … have great Healthcare soon after Tax Cuts!”

2019: More Talk, More Tweets

March and April: A Moving Target

It seems that 2018 was a quiet time — at least for presidential promises regarding a soon-to-be-unveiled health plan. It was reported that conservative groups were working on an Obamacare replacement plan. But in 2019, Trump again took up the health plan mantle with this March 26 tweet: “The Republican Party will become ‘The Party of Healthcare!’” Two days later, in remarks to reporters before boarding Marine One, Trump said that “we’re working on a plan now,” but again updated the timeline, saying, “There’s no very great rush from the standpoint” because he was waiting on the court decision for Obamacare. This was a reference to Texas v. U.S., the lawsuit brought by a group of Republican governors to overturn the ACA. It is currently pending before the Supreme Court.

Backtracking from his earlier promises to repeal and replace Obamacare within his first 100 days in office, Trump on April 3 tweeted: “I was never planning a vote prior to the 2020 Election on the wonderful HealthCare package that some very talented people are now developing for me & the Republican Party. It will be on full display during the Election as a much better & less expensive alternative to ObamaCare…”

June 16:

In an interview with ABC News, Trump again said a health care plan would be coming shortly.

“We’re going to produce phenomenal health care. And we already have the concept of the plan. And it’ll be much better health care,” Trump told George Stephanopoulos. When Stephanopoulos asked if he was going to tell people what the plan was, Trump responded: “Yeah, we’ll be announcing that in two months, maybe less.”

June 26:

But then, timing again changed as Trump promised a sweeping health plan after the 2020 election. “If we win the House back, keep the Senate and keep the presidency, we’ll have a plan that blows away ObamaCare,” Trump said in a speech to the Faith and Freedom Coalition’s Road to the Majority conference.

Oct. 3:

He reiterated this post-2020 election pledge in a speech to Florida retirees. “If the Republicans take back the House, keep the Senate, keep the presidency — we’re gonna have a fantastic plan,” Trump said.

Oct. 25:

Trump told reporters that Republicans have a “great” health care plan. “You’ll have health care the likes of which you’ve never seen,” he said.

2020: ‘Two Weeks’

Feb. 10:

During a White House business session with governors, Trump commented on the Republican governors’ lawsuit to undo the ACA and whether protections for preexisting conditions would be lost: “If a law is overturned, that’s OK, because the new law’s going to have it in.”

May 6:

During the signing of a proclamation to honor National Nurses Day, Trump again said Obamacare would be replaced “with great healthcare at a lesser price, and preexisting conditions will be included and you won’t have the individual mandate.”

July 19:

Trump told Chris Wallace in a Fox News interview that a health care plan would be unveiled within two weeks: “We’re signing a health care plan within two weeks, a full and complete health care plan that the Supreme Court decision on DACA gave me the right to do.”

July 31:

With no sign of a plan yet, reporters asked Trump about it at a Florida event. Trump responded that a “very inclusive” health care plan was coming and “I’ll be signing it sometime very soon.”

Aug. 3:

Pushing the timeline once again, Trump said during a press briefing that the health care plan would be introduced “hopefully, prior to the end of the month.”

Aug. 7:

Citing his two-week timeline once again, Trump said during a press briefing that he would pursue a major executive order in the next two weeks “requiring health insurance companies to cover all preexisting conditions for all customers.” Trump also said that covering preexisting conditions had “never been done before,” despite the ACA provisions outlining protections for people who have preexisting conditions being among the law’s most popular components. The Trump administration has backed the effort to overturn the ACA — including these protections — now pending before the Supreme Court.

Aug. 10:

In response to a reporter’s question about why he was planning to issue an executive order when the ACA already protects those with preexisting conditions, Trump said: “Just a double safety net, and just to let people know that the Republicans are totally strongly in favor of … taking care of people with preexisting conditions. It’s a second platform. We have: Preexisting conditions will be taken care of 100% by Republicans and the Republican Party.”

Just before publication, we asked the White House for more information regarding when exactly the plan might be unveiled. The press office did not respond to our request for comment.

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Apple Watch's abnormal pulse feature driving many unnecessary healthcare visits, Mayo Clinic researchers say |

 Apple Smart Watch 4 Pulse oximetry, EKG, GPS, Cell 
                              Apple Watch Rear Sensors


"Only one in seven self-referrals to physicians confirm a cardiac irregularity alert with an Apple Watch. The Apple Watch is not a diagnostic monitor and serves only as a screening device.

"The observation that new clinically actionable cardiovascular diagnoses of interest were diagnosed in only 11.4% of patients following medical evaluation as directed by the treating provider suggests a high false-positive rate as a screening tool for undiagnosed cardiovascular disease," Mayo Clinic researchers wrote in the Journal of the American Medical Informatics Association. "False-positive screening results have the potential to lead to excessive healthcare resource utilization and anxiety among the 'worried well.'”

The retrospective look at clinical documentation also suggests that a sizable portion of those presenting used the Apple Watch's feature "in a manner inconsistent with FDA guidance." The abnormal pulse detection feature is accessible across all generations of Apple Watch devices and is not to be confused with the ECG atrial fibrillation tool introduced with the Series 4 Apple Watch.

Among 264 patients whose clinical documentation was included in the study, 15.5% had records explicitly noting an abnormal pulse alert generated by the feature. The remainder included a reference to the watch and detection of abnormal pulse but did not explicitly mention that the user had received a generated alert, which the researchers noted could be a result of either incomplete documentation or the patient's manual use of the Apple Watch's heart monitoring application.

Patients who experienced symptoms were more likely to undergo diagnostic testing as part of their evaluation (78.5% versus 60.9%; p = .004). There was no significant difference in the proportion of patients with or without a documented abnormal pulse alert from the watch who underwent diagnostic testing.

Overall, 11.4% of patients received clinically actionable diagnoses. This diagnosis rate rose slightly to 15% among those documented to have received the alert.

"Therefore, for patients who experienced an abnormal pulse alert and presented for medical evaluation, 7 (95% confidence interval, 3.5-14.5) patients needed to be evaluated to establish [one] diagnosis of clinically actionable cardiovascular disease," the researchers wrote. "Among the 15 asymptomatic patients who presented following an abnormal pulse alert, only one was diagnosed with a clinically actionable cardiovascular diagnosis, yielding a number needed to diagnose of 15 (95% confidence interval, 2.9-286.5)."

Also of note were the patient populations included in the analysis. Twenty-two percent had pre-existing atrial fibrillation and 8.7% were younger than 22 years – both of which would exclude these patients from the FDA's guidance for this feature."

Author's note:

Regardless of the Mayo Clinic's FDA's guidance for use of the Apple watch physicians must make the evaluation and determination for each patient.  The data reveals that the information must be taken with historical information.  Physical examination is also part of the mandatory evacuation. The comments about the increase in utilization may affect health plan coverage.





Apple Watch's abnormal pulse feature driving many unnecessary healthcare visits, Mayo Clinic researchers say | MobiHealthNews

Friday, September 18, 2020

FDA-approved medical devices and algorithms: an online database | Digital Medicine

Credits:  Stan Benjamens, Pranavsingh Dhunnoo & Bertalan Meskó



Introduction

The 2010s has brought a rise in the number of studies and papers discussing the role of artificial intelligence (AI) and machine learning (ML) in medicine and healthcare (AI/ML). The number of life science papers describing AI/ML rose from 596 in 2010 to 12,422 in 2019. While we are at the beginning of the AI/ML era, the expectations are high and experts foresee that AI/ML shows potential for diagnosing, managing and treating a wide variety of medical conditions1.

Indeed, AI/ML-based technologies have been shown to support several medical specialties from radiology2 and oncology3 to ophthalmology4 and general medical decision-making5. ML models have been shown to reduce waiting times6; improve medication adherence7; customize insulin dosages8; or help interpret magnetic resonance images9, among others. AI/ML- based technologies are coming to electronic health record systems and AI based notifications and messaging systems.

We classify technology like AI/ML-based if official FDA announcements, communications by the company or other publicly available information resources used the expressions ‘deep learning,’ ‘machine learning,’ ‘deep neural networks,’ ‘artificial intelligence,’ and/or ‘AI’ to describe the technology11. For simplicity, we use the term “AI/ML-based” to denote these technologies in this paper. With the increasing expertise and attention on AI/ML in the medical field, the opportunities and possible implications of its use are the topics of an ongoing debate12. A crucial element in this implementation debate is regulating such technologies.Because of the high-risk nature of these medical devices and the unknown consequences of using AI/ML for medical decision-making and data analysis, the FDA has stringent regulatory requirements for medical device licensing. Developers of AI/ML-based medical devices and algorithms have to go through rigorous processes that are time and resource consuming. This can be considered pivotal as a barrier for the introduction of AI/ML in medicine.

Before medical hardware or software is legally made available in the US market, the parent company has to submit it to the FDA for evaluation. For medically oriented AI/ML-based algorithms, the regulatory body has three levels of clearance, namely, 510(k)14, premarket approval15, and the de novo pathway16, each of which needs specific criteria to be fulfilled in order to be granted (Table 1). This process is similar to drug approvals.  

Table 1 Descriptions of the types of FDA approvals for AI/ML-based medical technologies.

From: The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

Level of FDA clearance Description

510(k) clearance A 510(k) clearance for an algorithm is granted when it has been shown to be at least as safe and effective as another similar, legally marketed algorithm. The submitter seeking this clearance must provide substantial proof of equivalence in their application. Without approval of being substantially equivalent to the other algorithm, the one pending approval cannot be legally marketed.

Premarket approval Premarket approval is issued to algorithms for Class III medical devices. The latter are those that can have a large impact on human health and as such, their evaluation undergoes more thorough scientific and regulatory processes to determine their safety and effectiveness. In order to approve an application, the FDA determines that the device’s safety and effectiveness is supported by satisfactory scientific evidence. Upon approval, the applicant can proceed with marketing the product. de novo pathway Regarding the de novo classification, it is used to classify those novel medical devices for which there are no legally marketed counterparts, but which offer adequate safety and effectiveness with general controls. The FDA performs a risk-based assessment of the device in question before approval and allowing the device to be marketed.

Table 1 Descriptions of the types of FDA approvals for AI/ML-based medical technologies.

From: The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

TABLE  Descriptions of the types of FDA approvals for AI/ML-based medical technologies. 
An infographic about the 29 FDA-approved, AI/ML-based medical technologies.
The two main medical specialties with AI/ML-based medical innovations are Radiology and Cardiology, with 21 (72.4%) and 4 (13.8%) FDA approved medical devices and algorithms respectively. The remaining medical devices and algorithms can be grouped as focusing on internal medicine/endocrinology, neurology, ophthalmology, emergency medicine, and oncology.
The medical field of radiology is the trendsetter regarding FDA-approved medical devices and algorithms, with the introduction of AI/ML-based solutions for worldwide applied image reading software. Examples are the three algorithms for Arterys Inc., Arterys Cardio DL, Arterys Oncology DL and Arterys MICA, which are connected to the workflow Picture Archiving and Communication Systems from main vendors as Siemens Healthineers AG (Germany) and GE Healthcare (USA)20. Six out of these 21 algorithms can be applied in the field of oncology, with three focusing on mammography analyses (ProFound™ AI Software V2.1, cmTriage and TransparaTM) and three others on CT-based lesion detection (Arterys Oncology DL, Arterys MICA and QuantX). This is followed by two algorithms focusing on brain image analyses, with innovations for stroke and hemorrhage detection (ContaCT, Accipiolx, and icobrain), and six algorithms to improve image processing, with noise and radiation dosage reduction (SubtlePET, Deep Learning Image Reconstruction, Advanced Intelligent Clear-IQ Engine, SubtleMR, AI-Rad Companion (Pulmonary) and AI-Rad Companion (Cardiovascular)). Another four algorithms focusing on acute care, with two algorithms for the assessment of pneumothorax (HealthPNX and Critical Care Suite), one focusing on wrist fracture diagnosis (OsteoDetect) and the Aidoc Medical BriefCase system for triage of head, spine, and chest injuries. The final two algorithms in this specialty can be applied for cardiovascular assessments, focusing on the assessment of the heart ejection fraction (EchoMD AEF Software and EchoGo Core).
During the past decade, the use of AI/ML-based medical innovations has become ubiquitous driven by specialty needs in the clinical process from diagnosis to remote monitoring and treatment.  Despite FDA approvals, end-users such as physicians, nurse practitioners must have the final word. Algorithms are continuously updated, and the FDA uses a "locked" or "adaptive" classification in order to monitor algorithms that 'learn' and change with time and use.
The authors clearly state the limitations for the FDA to accomplish this process, explaining that other organizations assess the accuracy of AI/ML-based devices.
eMurmer ID, CSD Labs GmbH), Apple Inc, being the ECG App and Apple Irregular Rhythm Notification Feature, Excel Medical Electronics, Spry Health, and Current Health, Stratoscientific, Inc. introduced the Steth IO device to analyze heart and lung sounds. BrainScope Company Inc. has introduced AI/ML for the evaluation of brain injuries. MindMotion GO (MindMaze SA), (Cantab Mobile, Cambridge Cognition Ltd), and seizure monitoring (Embrace, Empatica Srl.). 
QbCheck (QbTech AB) and ReSET-O (Pear Therapeutics Inc.). With QbCheck, healthcare workers can substantiate their diagnosis or rule out attention deficit hyperactivity disorder (ADHD), enhancing objective medical decisions in psychiatry29, whereas ReSET-O can be applied for patients with Opioid Use Disorder, providing cognitive behavioral therapy as a mobile medical application for prescription use only. As a next step, the ReSET-O algorithm will be used in a randomized controlled trial, which is scheduled to start this year (April 2020)30.
The FDA has a clinical trial protocol for drugs, which may also be applied to devices and AI/ML-based devices and software.
A challenge has developed for the FDAs search algorithm, which itself will require an AI/ML-based search-based method beyond its current version.
Users of AI/ML-based software need (CME) Continuing Medical Education in each specialty.
The ACMGE as the accrediting body for medical education should supervise this as a requirement for the training of physicians

Reference source:
The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database | npj Digital Medicine

Monday, September 14, 2020

Stressors Take Toll on Students’ Mental Health -








Back to school time of year brings anxiety to some students while others are anxious to return to a routine discipline, friends, and sports.  The new routine of remote learning will cause new challenges for some, while some students will thrive in an independent environment.  In some cases, it will be better.

Students will learn at their own pace. Some students will jump ahead, while some will lag behind, in much the same was in a normal school.

We also need to consider the teacher's needs and responsibilities. Teachers will not have physical responsibility for student safety. Social interaction and disruptive behavior will be lessened. Along with the technical challenges of video conferencing, new techniques will be learned. The new 'normalcy' will also prepare students for the new workplace of remote work.

As many predicted Covid 19 has transformed our lives, at work, at home, and in education.

Distance learning may not be appropriate for early elementary school where physical presence is important for developmental socialization.

Surveys of parents with school-age children reveal the mental health challenges faced by their young ones. A Gallup poll conducted in May found that among parents with children in kindergarten through grade 12, 29% said their child was “already experiencing harm” to their emotional or mental health because of physical distancing and pandemic-related closures of schools and businesses.

Classroom with Social Distancing


Typical Classroom, without social distancing

“Trauma on Top of Trauma”

Students from kindergarten through graduate school are already returning to their studies amid both the pandemic and widespread protests of racial injustice and police violence. Experts worry that these compounding stressors are taking a toll on the mental, emotional, and physical health of young people.

Finally, whatever happens, it is an opportunity to study the effects and make plans for a new future.