Here are a few I came across last week.
Note: Each link is followed by a title and few paragraphs. For the full article click on the link above title of the article. Note also that full access to some links may require site registration or subscription payment.
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https://ehrintelligence.com/news/ehealth-exchange-reaches-1-billion-hie-transactions-per-month
eHealth Exchange Reaches 1 Billion HIE Transactions Per Month
eHealth Exchange officials noted that the HIE intends to apply to become a TEFCA Qualified Health Information Network (QHIN).
June 03, 2022 - eHealth Exchange, a health information exchange (HIE), announced that the eHealth Exchange Hub platform surpassed one billion requests processed for the first month ever in May 2022.
eHealth Exchange’s Hub provides network members with an application programming interface (API) that enables interoperability with five federal agencies and the nation’s leading health systems, pharmacies, HIEs, medical groups, and others to reduce information sharing expenses and complexities.
“The platform reduces the burdens of health information exchange on healthcare facilities, meaning these facilities can enhance patient-centric services easily and reliably,” Jay Nakashima, executive director of eHealth Exchange, noted in a public statement.
“After near-misses for months, we are proud to have hit this important milestone and look forward to continuing to provide our network members with efficient and cost-effective interoperability,” Nakashima continued.
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Interoperability with open standards: let’s kindle a discussion about FHIR
The future of healthcare systems may be open, but how are we going to get there? asks Vivek Krishnan, chief technology officer at Alcidion Group. There’s no doubt that OpenEHR and FHIR will both have a role to play, however, the UK seems to be focusing on OpenEHR – when FHIR has a lot to offer trusts and suppliers.
DHI June 1 2022
The future of healthcare systems lies in open standards that free data from traditional, stand-alone silos and make it available to the many applications that need it. But how are we going to reach that future?
Realistically, we have two options: open Electronic Health Record, better known as openEHR and Fast Healthcare Interoperability Resources, or FHIR. I’m not going to argue that one is better than the other. They both have advantages and disadvantages and they will both have a role to play in the digitisation of the NHS.
However, it sometimes feels like openEHR has become the focus of attention in the UK and I’d like to see more debate about the role of FHIR and open platform architectures that use FHIR to natively extract, store and re-export data to applications.
This is the model that Alcidion uses in its Miya Precision platform, and I assert that it has some benefits for innovative suppliers, trusts and Integrated Care Systems.
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https://healthitsecurity.com/news/a-review-of-common-hipaa-physical-safeguards
Common HIPAA Physical Safeguards Under The HIPAA Security Rule
HIPAA physical safeguards are crucial to protecting electronic protected health information (ePHI) and are essential to maintaining HIPAA compliance.
June 03, 2022 - HIPAA physical safeguards are an essential aspect to any covered entity’s PHI security, but could easily be overlooked. Technical safeguards and administrative safeguards could easily be pushed to the forefront of a covered entity’s overall health data security plan. However, physical safeguards are also critical, and must be able to work seamlessly with the other two federal requirements.
Whether an organization needs to review its storage methods for portable devices, or is considering a new system for its security cameras, understanding the basic needs for HIPAA physical safeguards is an important aspect in keeping an organization’s sensitive data secure.
What are HIPAA physical safeguards?
The HIPAA Security Rule describes physical safeguards as the “physical measures, policies, and procedures to protect a covered entity’s electronic information systems and related buildings and equipment, from natural and environmental hazards, and unauthorized intrusion.” Essentially, a covered entity needs to consider all physical access to ePHI. Everything from the healthcare organization office, to employees’ homes, or even a separate physical storage center needs to be properly secured.
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https://www.informationweek.com/healthcare/connected-healthcare-takes-huge-leap-forward
Connected Healthcare Takes Huge Leap Forward
Digital disruption that previously hit retail, financial services and many other sectors is now descending on healthcare.
Samuel Greengard Contributing Reporter
June 02, 2022
Yet it wasn’t until early 2020, when the pandemic arrived, that there was a sudden and urgent need to pivot to a connected framework. Suddenly, doctors and other medical professionals began substituting in-person visits with video consults and remote monitoring. Smart watches, digital thermometers and blood oximeters played a crucial role in collecting and sharing data.
This rapid shift to connected healthcare has unleashed shockwaves. “COVID has pushed electronic health and wellness devices into the forefront,” says Allyson Hein, medical device industry lead for Clarkston Consulting. “These systems and devices have the potential to completely reshape care.”
For healthcare executives, the stakes are enormous. Disruption that previously hit retail, financial services and many other sectors is now descending on healthcare. “There are remarkable opportunities to drive cost and quality improvements but also introduce new products and services,” says Benjamin Schooley, associate professor of Integrated Information Technology at the University of South Carolina.
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https://www.medscape.com/viewarticle/974961
Goodbye Pagers, Hello Clinical Texting ― How to Make the Transition Painless
Despite the consumer shift from pagers to cellphones and smartphones, paging has remained a communication staple among healthcare professionals.
But that's changing. More and more hospitals are replacing pagers with clinical texting systems that allow clinicians to send and receive patient-care messages using smartphones.
"This is a trend we see happening all over in medicine," says Joy Lee, PhD, a research scientist at Regenstrief Institute and assistant professor of medicine at Indiana University School of Medicine.
These messages could be team communications ("I saw the patient you wanted a consultation for in room X") or, say, an update on a patient's blood sugar level. "It's a lot of informational transactions that would be happening in healthcare anyway," Lee says. "It's just now happening over smartphones rather than pagers."
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https://medcitynews.com/2022/06/to-improve-emr-satisfaction-work-on-speed-and-reliability-first/
To improve EMR satisfaction, work on speed and reliability first
Providers would be wise to improve their EMR system response time and reliability, as these two measures critically influence clinician satisfaction. These improvements are acutely needed amid healthcare’s workforce shortage — burnout and EMR dissatisfaction are key factors associated with clinicians' likelihood to resign.
By Katie Adams
Jun 2, 2022 at 2:02 PM
Nearly half of clinicians think their EMR does not load fast enough, and nearly a quarter agree their system is not available when they need it, according to a KLAS report released Wednesday.
Given the survey response, providers would be wise to improve their EMR system response time and reliability, as these two measures critically influence clinician satisfaction. These improvements are acutely needed amid healthcare’s workforce shortage — a separate KLAS report released in April found that burnout and EMR dissatisfaction are key factors associated with clinicians’ likelihood to resign.
For its most recent report, KLAS surveyed more than 295,000 clinicians across more than 270 healthcare organizations. Only 18 organizations had 90% of their respondents report few or no difficulties with EMR availability. Given that widespread dissatisfaction abounds regarding EMRs in general, it was perhaps not a surprise that no single organization had more than 90% respondents agree that they encountered few or no issues with EMR availability.
One frustrated nurse respondent responded:
“There are numerous alerts that pop up all the time that are not helpful at all — not at all. These alerts are repetitive, inappropriate, immediately dismissible, and just another button to push when I am already busy. I have been waiting for 10 minutes for the EMR to load, and my patient who just had major surgery is screaming in pain.”
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The Challenges of Reducing Clinicians’ Administrative Burdens
June 3, 2022
The following is a guest article by Joel Landau, Founder and Chairman of The Allure Group.
Sadly, most of us realize now that the promise of a “paperless society” is unlikely to become a reality. Despite technology’s ability to eliminate some of the more tedious tasks like filling out endless insurance forms, and paying bills, paperwork still exists. And even though more and more information is shared online, completing such forms is time-consuming as well, and can sometimes actually create more work. Nowhere is this more apparent than in the healthcare field. Despite the increased use of electronic health records (EHRs) and other technology, physicians, nurses, and other healthcare providers are reporting record levels of burnout, compounded by the stress placed on clinicians by the seemingly unending COVID-19 pandemic.
Studies show that up to 42 percent of doctors suffer from burnout, and the main reason cited is too many administrative tasks, along with too many hours spent at work. Most physicians work close to 51 hours a week, with almost half of their workday spent on administrative work rather than patient care. Administrative burden plays a key role in heightened stress levels for healthcare workers. Doctors report wasting an average of 45 minutes a day using outdated communication technology, resulting in a lack of productivity and costing U.S. hospitals more than $8 billion annually.
To alleviate clinician administrative burnout, the Center for Medicare and Medicaid Services (CMS), the American Medical Association (AMA), and other regulators and payers have eliminated some nonessential administrative tasks and reduced preexisting constraints on team-based care, especially during and after the pandemic. Even before COVID-19 emerged, the American College of Physicians and CMS adopted a mindset of “Patients over Paperwork” to help providers spend more time with patients and less on administrative chores.
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https://ehrintelligence.com/news/onc-2015-edition-health-it-adoption-reduced-duplicate-orders
ONC 2015 Edition Health IT Adoption Reduced Duplicate Orders
ONC 2015 Edition Health IT adoption decreased the likelihood of duplicate orders by 40 percent. But, hospitals that also engaged in interoperable data exchange were even less likely to have duplicate tests.
June 02, 2022 - The Office of the National Coordinator for Health IT’s (ONC’s) 2015 Edition Health IT Certification Criteria which in turn reduced the likelihood of duplicate orders among hospitals that adopted the edition, a boon for health data interoperability, the agency celebrated.
Unnecessary duplicate laboratory testing is common and costly. Experts estimate that in 2015, $65 billion was spent on lab testing alone, with nearly 20 to 30 percent of that used to perform unnecessary duplicate tests. Additionally, unnecessary duplicate medical imaging adds roughly $30 billion to annual US healthcare costs.
However, health IT can improve care coordination and remove inefficiencies within these domains.
The study, published in the Journal of the American Medical Informatics Association, examined the impact hospital adoption of the 2015 Edition Health IT Certification Criteria (2015 Edition) had on duplicate lab and imaging tests.
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Machine-Learning Platform Can Accurately Predict Surgical Complications
Researchers from the University of Florida have successfully developed a machine-learning model to help clinicians predict and address postoperative complications.
June 02, 2022 - University of Florida (UF) researchers have developed a machine-learning (ML) platform, called MySurgeryRisk, that can predict surgical complications as accurately as clinicians.
Surgery and potential postoperative complications provide considerable challenges for clinicians and patients. According to a study published in BMC Surgery last year, the total volume of major surgeries performed annually worldwide was estimated to be 312.9 million in 2012, and an estimated 7-15 percent of these patients would experience a major complication.
The researchers created MySurgeryRisk to help prevent some of these outcomes by predicting risk rates for patients planning to undergo surgery. The platform was developed using 74,000 procedures involving 58,000 adult patients at UF Health, and it was trained to predict surgical complications using 135 variables extracted from patient EMRs. These variables included clinical, laboratory, pharmacy, demographic, and other data.
The algorithm was then tasked with predicting prolonged intensive care unit stays and mortality risk after procedures. The platform also predicts the risk of eight major surgical complications, including neurological issues, cardiovascular issues, sepsis, and acute kidney injury.
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Telehealth Raises Visit Completion Rate by 20% for Rural Residents
A study found that telehealth can be used to expand access to primary care in rural areas as it can help increase the proportion of appointments completed.
June 02, 2022 - Using data from a rural Appalachian population, a study published in the Journal of the American Board of Family Medicine found that telemedicine is an effective alternative to in-person care for rural residents, helping to drive up appointment completion rates.
In the study, researchers examined a sample of 110,999 patient visits, 13,013 of which occurred through telemedicine. All data came from the West Virginia University Department of Family Medicine from January 2019 to November 2020. Researchers excluded data belonging to patients who lived more than 60 miles outside the West Virginia state line.
Researchers conducted a retrospective cohort study, using the data to determine any correlation between the rate of visit completion and the setting in which a visit occurred.
They found that telehealth can drive appointment completion rates up by about 20 percent.
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FBI Blocked Iranian-Backed Cyberattack on Boston Children’s Hospital Last Year
FBI Director Christopher Wray said the bureau thwarted an Iranian government-backed cyberattack against Boston Children’s Hospital in 2021.
By Jill McKeon
June 02, 2022 - Federal Bureau of Investigation (FBI) Director Christopher Wray revealed that Iranian government-backed hackers attempted to execute a cyberattack against Boston Children’s Hospital in June 2021.
In a speech delivered at Boston College during the Boston Conference on Cyber Security, Wray called the incident “one of the most despicable” cyberattacks he had ever seen.
“We got a report from one of our intelligence partners indicating Boston Children’s was about to be targeted. And, understanding the urgency of the situation, the cyber squad in our Boston Field Office raced to notify the hospital,” Wray said.
“Our folks got the hospital’s team the information they needed to stop the danger right away. We were able to help them ID and then mitigate the threat. And quick actions by everyone involved, especially at the hospital, protected both the network and the sick kids who depend on it.”
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https://www.healthcareitnews.com/news/oracles-acquisition-cerner-approved-could-close-june-6
Oracle's acquisition of Cerner is approved, could close June 6
"We expect Cerner to be a huge growth engine for years to come," said Oracle CEO Safra Catz of the $28.3 billion deal.
By Mike Miliard
June 02, 2022 09:40 AM
Oracle announced on Wednesday that, more than five months since the deal was first announced, all necessary antitrust and other regulatory approvals have been secured for its proposed purchase of Cerner, and that the acquisition should be finalized early next week.
WHY IT
MATTERS
Most notably, that includes the unconditional antitrust clearance from the
European Commission clearance that Oracle gained this past week. Earlier this
year, the window for the Federal Trade Commission and the Department of
Justice's own review of the deal had been extended to Feb. 22.
With those approvals in hand, Oracle says it now expects to complete the acquisition with an all-cash tender offer for $95 per share, totaling approximately $28.3 billion, that's immediately accretive to Oracle's earnings.
The company says it expects the deal to close next week, on June 6, subject to the conditions described in the statement filed with the Securities and Exchange Commission on January 19, and presuming other closing conditions are met.
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Faulty Pulse Oximetry Readings Delayed COVID-19 Care For Minority Groups
Due to inaccurate pulse oximetry measurements, Black and Hispanic patients were less likely to be recognized as eligible for COVID-19 treatment than White patients, a new study shows.
By Anuja Vaidya
June 01, 2022 - Pulse oximeters often showed inaccurate blood oxygen readings for Asian, Black, and Hispanic patients resulting in delayed COVID-19 care for these populations during the pandemic, according to a new study.
Published in JAMA Internal Medicine, the study included clinical data from five referral centers and community hospitals in the Johns Hopkins Health System. Data from patients with COVID-19 who self-identified as Asian, Black, Hispanic, or White were included in the study.
Researchers identified patients with occult hypoxemia, that is, patients with oxygen saturation levels of less than 88 percent in arterial blood (SaO2) and concurrent pulse oximetry (SpO2) readings between 92 percent and 96 percent. They then compared the proportion of patients with occult hypoxemia by race and ethnicity.
Of 7,126 patients with COVID-19, 1,216 Asian, Black, and Hispanic and 460 White individuals had 32,282 concurrently measured oxygen saturation levels in arterial blood and by pulse oximetry. Nineteen Asian, 136 Black, and 64 Hispanic patients had occult hypoxemia compared with 79 White patients.
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Patient Engagement Technology Not Aligned with Patient Expectations
There is a gap between what patient engagement technology offers and patient expectations, as 67 percent of patients want the ability to schedule and reschedule healthcare appointments, but most don’t have it.
June 01, 2022 - Patients are demanding more digital health tools that allow them to manage their care, yet this is the area patient engagement technology vendors most fall the most of patient expectations, the latest KLAS report noted.
The Patient Perspectives on Patient Engagement Technology 2022, obtained via email, gathered survey responses from 12,861 patients across the US, specifically looking at patient perspectives around healthcare information technology (HIT).
The pandemic has emphasized the importance of accommodating patient needs to improve care quality and outcomes. Still, patients are left out of conversations about healthcare information technology (HIT).
Ideally, vendors should be aligning their technology strategies with patient needs and expectations, especially since more patients than ever before are utilizing patient engagement technology.
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IT Specialist Charged in Healthcare Cyberattack Highlights Insider Threat Risks
An IT specialist has been indicted on a federal criminal charge after allegedly hacking into a Chicago healthcare organization’s server where he formerly worked.
By Jill McKeon
June 01, 2022 - An IT specialist has been charged for allegedly hacking into a Chicago healthcare organization’s server in 2018, the Department of Justice (DOJ) announced.
Aaron Lockner, 35, of Downers Grove, Illinois, formerly worked for an IT company that had a contract with the impacted healthcare organization. As a result, Lockner had access to the healthcare organization’s computer network.
Two months before the incident, Lockner was allegedly denied an employment position at the healthcare company. A few months later, Lockner was terminated from the IT firm.
According to the indictment, Lockner allegedly “knowingly caused the transmission of a program, information, code, and command, and as a result of such conduct, intentionally caused damage without authorization to a protected computer.”
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https://www.healthcareitnews.com/news/christianacare-rolls-out-cobots-help-nurses-non-clinical-tasks
ChristianaCare rolls out 'cobots' to help nurses with nonclinical tasks
The "collaborative robots," known as Moxi, will be linked with the Delaware health system's Cerner EHR. They're designed to make deliveries and collections, helping ease clinicians' workload and enabling them to focus on care.
By Mike Miliard
May 26, 2022 09:17 AM
ChristianaCare this week announced some new help to augment its workforce: robotic assistants that can help nurses and other hospital staff spend more time with patients by automatic certain time-intensive tasks.
WHY IT
MATTERS
The technology, called Moxi, is a collaborative robot that can work alongside
nurses and interact with them directly, performing nonclinical tasks such as
deliveries and pickups to enable them to focus on care delivery.
ChristianaCare purchased five of these 300-pound "cobots" – which can work 22-hour shifts, be fully charged in two hours and carry up to 70 pounds – with a $1.5 million grant from the American Nurses Foundation.
The Moxi cobots will soon be integrated with ChristianaCare's Cerner electronic health record platform, officials say.
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https://www.washingtonpost.com/technology/2022/05/24/remote-school-app-tracking-privacy/
Remote learning apps shared children’s data at a ‘dizzying scale’
The educational tools used by students during the pandemic shared their information with advertisers and data brokers that could track them around the Web, an international investigation found
By Drew Harwell
May 24, 2022 at 9:00 p.m. EDT
Millions of children had their online behaviors and personal information tracked by the apps and websites they used for school during the pandemic, according to an international investigation that raises concerns about the impact remote learning had on children’s privacy online.
The educational tools were recommended by school districts and offered interactive math and reading lessons to children as young as prekindergarten. But many of them also collected students’ information and shared it with marketers and data brokers, who could then build data profiles used to target the children with ads that follow them around the Web.
Those findings come from the most comprehensive study to date on the technology that children and parents relied on for nearly two years as basic education shifted from schools to homes.
Researchers with the advocacy group Human Rights Watch analyzed 164 educational apps and websites used in 49 countries, and they shared their findings with The Washington Post and 12 other news organizations around the world. The consortium, EdTech Exposed, was coordinated by the investigative nonprofit the Signals Network and conducted further reporting and technical review.
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Improving data capacity for maternal health research through EHR data standards
Electronic health records collect a wealth of data that researchers can use to improve care for mothers and infants. Linking it with other data creates a powerful resource to learn more about clinical and SDOH factors that affect pregnancy.
May 31, 2022 02:17 PM
Maternal mortality rates in the U.S. have climbed in recent years. Moreover, mortality rates are significantly higher for Black women and American Indian and Alaska Native American women than the rest of the population. Improving maternal health outcomes and eliminating disparities are ongoing priorities for the Department of Health and Human Services, reinforced by the Biden-Harris administration.
While progress has been made, there remain opportunities to improve the collection, linkage, and analysis of data collected at the point of care. Strengthening the quality of clinical data holds enormous potential for improving maternal health outcomes as well as supporting patient-centered outcomes research on the effectiveness of maternal healthcare services and interventions.
A key need is for better data standards in electronic health records to understand possible risk factors for maternal mortality and poor maternal and infant health outcomes. EHR data differ by clinical settings and data standardization across systems is essential for meaningful and unbiased use for research. Furthermore, data standards must be specific for maternal health to facilitate data linkages for a life span approach to women’s health that also includes their infants’ health.
Data standardization, interoperability are critical to progress
EHRs collect a wealth of data that could be used by researchers to provide a more complete picture of the health and healthcare for pregnant women and mothers. Linking EHR data with other data – such as health insurance claims, social determinants of health, or mortality data creates a powerful resource for researchers to generate evidence about the clinical, social, and demographic factors that affect pregnancy outcomes for both mother and infants.
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EHR alerts boost care for patients with HFrEF
Michael Walter | May 31, 2022 | Heart Failure
Researchers from the Yale School of Medicine have found that electronic health record (EHR) alerts can help improve the quality of care for outpatients with heart failure with reduced ejection fraction (HFrEF). The group shared its findings in the Journal of the American College of Cardiology.[1]
“Efforts aimed at optimizing guideline-directed medical therapy (GDMT) in patients with HFrEF are abundant across hospitals and healthcare systems, but there is limited evidence to support whether such resource-intensive interventions have any demonstrable benefit,” wrote first author Lama Ghazi, MD, PhD, a fellow with Yale’s Clinical and Transnational Research Accelerator, and colleagues.
Ghazi et al. examined the impact of an EHR-based alert system designed, with help from physicians, to inform healthcare providers about key data such as the patient’s current left ventricular ejection fraction (LVEF), blood pressure and heart rate.
The alert also provides a detailed rundown of which recommended medications the patient is and is not currently taking and FDA-supported details about each medication. The provider receiving the alert is then asked to respond to the alert by saying, “I will adjust medications,” “medication changes not clinically indicated” or “defer for other reason.” A free text field is also provided if the individual responding to the alert wants to add any additional comments.
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NZ-based AI firm launches tool to assess heart risk through retinal scans in U.S.
Jun 1, 2022 02:01am
Toku Eyes, a New Zealand-based healthcare AI company, is launching its tool that assesses heart risk through a retinal scan in the U.S.
The tool, called ORAiCLE, uses an AI platform to identify cardiovascular threats more accurately than existing risk calculators, the company claims. The platform recognizes subtle changes in aspects like blood vessels and pigmentation to identify a person’s risk of a stroke or heart attack in the next five years.
Many Americans with diabetes are at risk of long-term complications like heart disease and blindness. Early diagnosis is critical for mitigating morbidity, but diagnosis has historically been a challenge.
“If you can see the future, you can change it,” Ehsan Vaghefi, co-founder and CEO of Toku Eyes, said in an announcement. “By looking inside the eyes, we get an in-depth view of what is happening inside the entire body to better assess the risk factors of each individual and identify high-risk individuals before their condition worsens. Our goal is to make health screening simple and easy to access for the entire population so we can get in front of underlying health risks and improve patient outcomes.”
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https://ehrintelligence.com/news/variation-in-loinc-code-adoption-impedes-lab-data-interoperability
Variation in LOINC Code Adoption Impedes Lab Data Interoperability
Medical centers vary in organizing, categorizing, and storing LIS catalog information, which hampers lab data interoperability and quality.
May 31, 2022 - Variation in the adoption of Logical Observation Identifiers Names and Codes (LOINC) codes has hampered laboratory data interoperability, according to a study published in JAMIA.
The objective of the (LOINC)-to-In Vitro Diagnostic (LIVD) specification, required by HHS for COVID-19 reporting, is to define an industry format to facilitate the publication of LOINC codes for vendor IVD tests and results.
Researchers compared gaps and similarities between diagnostic test manufacturers’ recommended LOINC codes for 331 tests and the LOINC codes used in five medical center laboratories for the same tests.
The medical centers varied in organizing, categorizing, and storing LIS catalog information, impacting data quality and interoperability.
The study authors noted six key findings:
- Medical center LIS test catalogs included data quality inaccuracies with LOINC, such as using codes that were not proper LOINC codes, trial LOINC codes, deprecated LOINC codes, and discouraged LOINC codes.
- Medical center laboratory information system (LIS) catalogs contained duplicative information or tests that changed meaning over time.
- Medical centers noted that the LIVD catalog is helpful as a centralized platform, taking away LOINC guesswork.
- Medical Centers also said the LIVD catalog is helpful in the selection of LOINC codes associated with specific COVID-19 testing platforms.
- There were minor inconsistencies in how manufacturers organized and stored IVD test information within LIVD catalogs, likely due to not using the same version of the LIVD standard.
- There is potential for the LIVD catalogs to help improve semantic interoperability and LIS data quality. There is also room for improvement of the LIVD catalog data elements and accessibility of LIVD files by labs.
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Researchers Call for ‘Distributed Approach’ to Clinical AI Regulation
Public health researchers argue that the centralized regulation of artificial intelligence at the national level is not sufficient for safety, efficacy, and equity.
May 31, 2022 - Researchers argue that the national, centralized regulation of clinical artificial intelligence (AI) is not sufficient and instead propose a hybrid model of centralized and decentralized regulation.
In an opinion piece published in PLOS Digital Health, public health researchers at Harvard note that the increase in clinical AI applications, combined with the need to adapt applications to account for differences between local health systems, creates a significant challenge for regulators.
Currently, the US Food and Drug Administration (FDA) regulates clinical AI under the classification of software-based medical devices. Medical device approval is typically obtained via premarket clearance, de novo classification, or premarket approval. In practice, this usually involves the approval of a “static” model, meaning that any change in data, algorithm, or intended use after initial approval requires reapplication for approval. To receive approval, developers must demonstrate a model’s performance on an appropriately heterogeneous dataset.
To improve parts of this process, the FDA has proposed a regulatory framework focused on modifications to clinical AI within the context of Software-as-a-Medical-Device (SaMD). This framework expands on the existing approach by adding new post-authorization considerations that are expected to be of greater importance to clinical AI, including recommendations for predetermined change control plans. These plans require the manufacturers of algorithms to specify which parameters of the application they intend to modify in the future and the intended methodology to operationalize those changes.
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VA Ordered to Report Performance of Troubled Health Records System to Congress
27 May 2022
Military.com | By Rebecca Kheel
The Department of Veterans Affairs will be required to regularly report the performance -- including incidents that risk patient safety -- of its troubled electronic health records systems to Congress under new legislation headed to the president's desk.
The Senate approved a bill Thursday to require the VA to submit quarterly reports to lawmakers on the performance and costs of the Electronic Health Record Modernization program, or EHRM. The bill already passed the House in a voice vote in November, meaning it now heads to President Joe Biden for his signature.
A VA hospital in Spokane, Washington, was forced to suspend patient admissions and appointments after the records system, estimated by the agency to cost $16.1 billion, crashed in March. Multiple inspector general reports and news stories have highlighted issues with the rollout of the system that risked patient safety, as well as cost overruns.
"The VA, and consequently our nation, has invested a great deal of time and money into the VA Electronic Health Record Modernization program," Senate Veterans Affairs Committee ranking member Sen. Jerry Moran, R-Kan., the lead sponsor of the Senate version of the bill, said in a statement.
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https://www.healthcareitnews.com/news/emea/will-nis2-directive-cybersecurity-be-enough
Will the NIS2 directive on cybersecurity be enough?
The EU is close to approving a new cybersecurity directive. Will it protect healthcare organisations from hackers?
May 31, 2022 11:57 AM
The European Council and Parliament reached an agreement on the directive known as Network Information Security directive (NIS2) earlier this month. Formal approval is expected over the next few weeks, with the French presidency “optimistic” that a final draft will be ready before its term ends, according to an EU source.
The new cybersecurity directive will cover the healthcare sector more broadly than the previous act. It includes medical device manufacturers and acknowledges the “increasing security threats that arose during the COVID-19 pandemic.” In the provisionally-agreed text, organisations that do not comply may be fined up to two per cent of annual revenue, or up to €10 million.
Greater collaboration means greater risk
But researchers have already expressed concerns about the directive’s potential to overlap with other pieces of legislation, such as governing medical devices and requirements on serious-incident reporting. This could create uncertainty, legal scholars say. Further, there are broader tensions affecting the EU’s cybersecurity policy. Some experts pointed out that responsibilities are awkwardly split between member states and the EU; others worry that that cyber concerns are not sufficiently integrated with policy development.
Robert Krimmer is professor of e-Governance at the University of Tartu in Estonia, where his research focuses on digital transformation, cross-border services and developing a digital society. He says that when it comes to cybersecurity a coordinated approach across boundaries is vital, particularly when citizens are involved.
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Drummond Group developing testing and certification program for pediatric EHRs
For its voluntary Pediatric Health IT Certification Program, it's piloting with NextGen, Office Practicum and PCC to help finalize test scripts.
By Mike Miliard
May 31, 2022 09:35 AM
Drummond Group this past week announced the launch of its new Pediatric Health IT Certification Program.
WHY IT
MATTERS
The program aims to build upon the Office of the National Coordinator for
Health IT's guidelines for voluntary certification of electronic health records
used by pediatricians.
It will provide a Drummond Certified certification seal to health IT software that successfully passes specified use cases and is therefore recognized for excellence in pediatrics testing. It will also enable IT vendors to differentiate themselves in the marketplace by showing advanced capabilities that go beyond baseline certifications.
For the pilot project of the certification program, Drummond will be drawing on feedback from a trio of health IT companies: NextGen Healthcare, Office Practicum and PCC.
They're helping finalize the test scripts which are based upon the 10 recommendations from the ONC in its 21st Century Cures Act Final Rule, the HL7 Pediatric Care Health IT Functional Profile R2.1 published in May 2022, and the Agency for Healthcare Research Children's EHR Format 2015 Priority List to advance child health, such as through interoperable immunization data for health systems, schools and public health agencies.
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https://www.healthcareitnews.com/news/emea/what-does-future-hold-ai-healthcare
What does the future hold for AI in healthcare?
Smart jumpsuits for babies and precision oncology are some of the innovative ways that AI could be used to turn data into actionable insights, which will be explored in more detail at HIMSS22 Europe in June.
By Tammy Lovell
May 30, 2022 02:52 AM
Can you imagine a future in which babies wear smart clothing to track their every move? It may sound like something from science fiction, but a romper suit being piloted in Helsinki, Copenhagen, and Pisa does exactly that.
The ‘motor assessment of infants jumpsuit’ (MAIJU) looks like typical baby clothing, but there is a crucial difference – it is full of sensors which assess child development.
“MAIJU offers the first of its kind quantitative assessment of infant’s motor abilities through the age from supine lying to fluent walking,” explains Professor Sampsa Vanhatalo, project lead at the University of Helsinki. “Such quantitation has not been possible anywhere, not even in hospitals. Here, we are bringing the solution to homes, which provides the only ecologically relevant context for motor assessment.”
Vanhatalo describes the path from wishful thinking about a solution to a possible clinical implementation as a “windy road”.
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Enjoy!
David.
We’re building a system where all American citizens’ health records not only exist at the hospital level, but they also are in a unified national health records database,”
ReplyDeleteOracle looking to reap some cash
"...all American citizens’ health records not only exist at the hospital level"
ReplyDeleteAll? Some maybe, but not all.
The one thing you can guarantee in the USA - not everyone trusts their government as much as Australian's trust theirs.