Saturday, December 11, 2021

Weekly Overseas Health IT Links – 11 December, 2021.

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://patientengagementhit.com/news/assessing-the-market-for-patient-experience-surveying

Assessing the Market for Patient Experience Surveying

Industry mainstay Press Ganey is still a leader for CAHPS surveying, but as more organizations begin to do real-time patient experience surveys other market leaders emerge.

By Sara Heath

December 03, 2021 - Press Ganey is still a leading vendor for CAHPS and patient experience surveying, according to a new KLAS Segment Insights Report.

But as the healthcare industry begins to embrace real-time patient experience surveying, other vendors like Qualtrics are starting to emerge, as well.

Patient experience surveying has long been a key part of clinical quality measurement. CAHPS surveys, or Consumer Assessment of Healthcare Providers and Systems surveys, have traditionally been the formal method for measuring patient experience and satisfaction, with many value-based care programs using the tool as part of their quality assessments.

According to the KLAS report, Press Ganey continues to be the market leader for CAHPS surveys, with 16 of its customers telling KLAS they use Press Ganey for CAHPS benchmarking. NRC Health likewise shows strength in CAHPS benchmarking, with 12 of its customers telling KLAS they use it for such.

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https://healthitsecurity.com/news/fda-mitre-mdic-create-medical-device-threat-modeling-playbook

FDA, MITRE, MDIC Create Medical Device Threat Modeling Playbook

MITRE and the Medical Device Innovation Consortium (MDIC) partnered with the FDA to release a playbook for medical device threat modeling.

By Jill McKeon

December 03, 2021 - MITRE and the Medical Device Innovation Consortium (MDIC) teamed up to release a playbook for medical device threat monitoring to help organizations strengthen the cybersecurity of medical devices.

The playbook incorporated insights from a series of threat modeling bootcamps for medical device manufacturers hosted by MITRE, MDIC and the Food and Drug Administration (FDA) in 2020 and 2021.

“Medical devices are increasingly complex and connected systems existing in complex connected ecosystems of healthcare delivery,” the playbook stated.

“Although standard lists of controls such as the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53 and ANSI/AAMI/IEC 80001 can ensure some baseline security capabilities, they fail to address the myriad of ways that medical devices are used, interface with the healthcare ecosystem, and most important, how security risks could result in unacceptable safety issues.”

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https://www.digitalhealth.net/2021/12/government-white-paper-digital-care-records/

Government white paper commits to more digital care records

A government white paper has committed to ensuring that at least 80% of social care providers have a digitised care record in place by March 2024.

Hanna Crouch – 01 December, 2021

The Adult Social Care Reform White Paper, which is part of the government’s wider social care plans, is backed by £5.4billion which will go towards helping to improve the physical, digital and technological infrastructure of care homes.

This includes at least £150million going towards improving care quality and safety, support independent living through new technology and digitisation such as digital care records, over the next ten years.

According to the paper, ‘only 40% of social care providers are fully digitised with the remainder using paper records’.

The paper adds: “By March 2024, we will ensure that at least 80% of social care providers have a digitised care record in place that can connect to a shared care record – a commitment that was set out in the draft Data saves lives: reshaping health and social care with data strategy.

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https://www.medpagetoday.com/meetingcoverage/rsna/95984

Artificial Intelligence Tool Gets High Marks in Reading Mammograms

— Breast cancer screening results show AI's mettle in real-world dataset

by Ed Susman, Contributing Writer, MedPage Today December 2, 2021

CHICAGO -- An artificial intelligence program designed to assist radiologists in reading breast cancer screening scans proved to be almost as good as trained doctors in a 3-year test, a researcher reported.

Of the 100 positives detected by humans reading the 12,120 cases in the 2016-2017 period at a single center, the artificial intelligence program achieved a sensitivity of 91%, a specificity rate of 91.11%, and a recall rate of 9.56% for the same cases, reported Gerald Lip, MD, of the University of Aberdeen in Scotland, at the annual meeting of the Radiological Society of North America.

The findings were similar when looking at the results for the 2017-19 period, which included 229 positives among 27,824 screens: The artificial intelligence algorithm achieved a sensitivity of 88.21%, a specificity rate of 90.92%, and a recall rate of 9.73%.

"The performance of this artificial intelligence tool shows a high degree of sensitivity, specificity, and an acceptable recall rate," Lip concluded. "The findings demonstrate how an artificial intelligence tool would perform as a stand-alone reader and its potential to contribute to the double reading workflow."

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https://www.statnews.com/2021/12/02/just-stupid-stuff-logistics-and-lack-of-testing-stymied-finding-omicron/

‘Just stupid stuff’: Logistics and lack of testing stymied finding the Omicron variant in the U.S.

By Megan Molteni Dec. 2, 2021

After South African scientists alerted the world last week to the new, concerning Omicron variant of SARS-CoV-2, researchers here in the U.S. warned that the highly mutated strain was likely already circulating on American soil. It was just a matter of time before someone found it.

On Thursday, health officials reported the country’s second Omicron infection, in a Minnesota man who attended an anime conference in New York days before his symptoms began. Notably, he had not traveled internationally, unlike the first case — a California resident recently returned from South Africa — indicating the occurrence of domestic transmission. But the timing of discovery has many wondering, “why did it take so long?”

According to details shared by the Minnesota Department of Health, the man, who is a resident of Hennepin County, home to the state’s most populous city, Minneapolis, first developed symptoms on Nov. 22. He took a PCR test on Nov. 24. News of Omicron broke on Nov. 25. Minnesota health officials didn’t confirm from sequencing data that his infection was caused by the Omicron variant until a week later, on the evening of Dec. 1.

By contrast, public health agencies in the U.K. found that country’s first cases of the new strain less than 48 hours after South Africa sounded the alarm.

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https://www.healthcareitnews.com/news/pandemic-stress-cyberattacks-are-compounding-degradation-care-delivery

Pandemic stress, cyberattacks are compounding degradation of care delivery

An researcher from CISA describes the findings of a report, which finds the U.S. healthcare infrastructure in "critical condition" thanks to COVID-19 and the disruption of ransomware and other security threats.

By Mike Miliard

December 03, 2021 09:00 AM

This past September, the U.S. Department of Homeland Security's Cybersecurity & Infrastructure Security Agency published a report designed to assess the health of the nation's hospitals and health systems.

Perhaps unsurprisingly, the report, "Provide Medical Care is in Critical Condition: Analysis and  Stakeholder Decision Support to Minimize Further Harm," doesn't offer encouraging news.

It finds the nationwide infrastructure enabling provision of medical care – one of CISA's 55 National Critical Functions – to be severely strained by the COVID-19 pandemic and all the clinical, financial, workforce and supply chain challenges it has brought,

The concurrent cyber-pandemic of rampant ransomware and nation-state skullduggery has only compounded the difficulties faced by providers.

As the report notes: "Beyond the obvious consequences of disruptions to diagnostic, testing, and treatment equipment, even minor reductions in efficiency caused by cyber incidents compound to increase staff workload and degrade the system's ability to provide medical care."

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https://www.stltoday.com/business/investment/personal-finance/medicare-s-telehealth-experiment-could-be-here-to-stay/article_f7e34ab2-c7e7-5e2a-a053-306690fd610f.html

Medicare’s Telehealth Experiment Could Be Here to Stay

Medicare beneficiaries used 63 times more telehealth services in 2020 than in 2019 after the federal government loosened Medicare’s strict telehealth rules due to the COVID-19 pandemic, according to a report released Friday by the Department of Health and Human Services.

The policy changes were intended to be temporary, but data on telehealth use is being analyzed to help policymakers decide the future of those services under Medicare.

The HHS report "provides valuable insights into telehealth usage during the pandemic," said Chiquita Brooks-LaSure, who leads the Centers for Medicare & Medicaid Services, in a press release. "CMS will use these insights — along with input from people with Medicare and providers across the country — to inform further Medicare telehealth policies."

How did Medicare’s telehealth rules change in 2020?

Prior to 2020, Original Medicare covered telehealth only under fairly narrow circumstances (private insurers offering Medicare Advantage plans have much greater discretion to set their own telehealth policies).

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https://mhealthintelligence.com/news/higher-costs-prompt-patients-to-switch-from-telehealth-to-in-person-care

Higher Costs Prompt Patients to Switch From Telehealth to In-Person Care

A new study revealed the impact of out-of-pocket costs on visit modality, showing that patients who preferred telehealth were likely to switch to in-person care if it was cheaper.

By Anuja Vaidya

December 02, 2021 - Patients who preferred telehealth visits were more sensitive to out-of-pocket cost than those who preferred in-person visits, according to a new study by the RAND Corporation, a nonprofit research organization.

Published in JAMA Network Open, the study aims to assess patient preferences for video visits once the COVID-19 pandemic has ended and to identify the role of out-of-pocket cost in changing the patient preference for virtual versus in-person care.

Researchers gathered data from the American Life Panel Omnibus Survey, conducted between March 8 and March 19. A total of 2,080 RAND American Life Panel members completed the survey.

About 45 percent of participants reported having had one or more video visits with healthcare providers since March 2020. Only 2.3 percent among them reported that they were unwilling to use it again in the future.

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https://imia-medinfo.org/wp/history-book/

IMIA History Book

IMIA acknowledges with great appreciation Dr. Casimir Kulikowski, Chair of IMIA’s History Working Group, for his unprecedented commitment and dedication in providing IMIA’s first published History Book.   Dr. Kulikowski was supported by the long standing and dedicated Vice Chairs  of the working group Dr. George Mihalas, Dr. Yalerio Yacubsohn, Dr. Robert Greenes and Dr. Hyeoun-Ae Park.


We are very glad that IMIA has published the long-awaited volume of personal narrative contributions as part of the IMIA History Working Group’s efforts over the past decade.  We greatly appreciate all the work of the individual contributors and thank those who in this way have shared their unique personal insights into the development of research and practices in our key biomedical and healthcare disciplines and their informatics technologies at an international level.  We are planning future activities which could lead to further volumes in this series covering the organizational histories of IMIA’s affiliated societies and associations, as well as narratives that can help broaden the scope of perspectives that inform the many worldwide efforts in our field. Please do not hesitate to share your comments on the book, and suggestions for future activities.

Casimir A. Kulikowski, George I. Mihalas, Hyeoun-Ae Park, Robert A. Greenes, Valerio Yacubsohn
Editors of the eBook International Medical Informatics and the Transformation of Healthcare, 2021 and Editorial Board of the IMIA History WG.

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https://histalk2.com/2021/12/02/news-12-3-21/

Announcements and Implementations

An ISMP Medication Safety Alert further explains the previously described problem in which three pharmacy data sources sent Surescripts incorrectly formatted medication history instructions, which caused problems such as “take 1 1/2 tablets daily” being sent to the network as “take 112 tablets daily.” Surescripts helped the three data sources fix their problem, removed their medication history response messages until they implement a permanent fix, and offers health systems and technology vendors a report of their impacted patients.

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https://www.healthcarefinancenews.com/news/cvs-health-partners-microsoft-advance-digital-first-strategy

2021

CVS Health partners with Microsoft to advance digital-first strategy

The organization hopes the collaboration will speed along development of a more data-driven, personalized customer experience.

Jeff Lagasse, Associate Editor

As part of efforts to accelerate a digital-centric strategy, CVS Health is teaming with Microsoft and will be tapping into its cloud computing and artificial intelligence technologies, the company announced this week.

CVS Health hopes the collaboration will speed along development of a more data-driven, personalized customer experience, while complying with patient privacy and confidentiality policies.

The idea is to combine information from different areas across the company, so CVS can enhance its omnichannel pharmacy capabilities and deliver customized health recommendations. The company said it will also scale up retail loyalty and personalization programs that use advanced machine learning models running on the cloud computing service Azure.

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https://www.healthcareitnews.com/news/zoom-announces-new-integration-cerner-ehr

Zoom announces new integration with Cerner EHR

The functionality is currently available for beta testing with some customers, allowing them to join scheduled sessions by clicking a link within a patient's chart.

By Kat Jercich

December 02, 2021 12:04 PM

[Ed. note: This piece has been updated to include comment from Cerner about the initiative.]

Zoom announced this week that it had launched an integration option with Cerner's electronic health record platform.   

The initiative, which is currently available to beta customers, is aimed at facilitating easier access to telehealth from within Cerner's EHR.  

"With virtual care here to stay, providers must focus on delivering a seamless experience for telehealth visits – one that’s easy, intuitive, and frictionless for patients, and secure, trusted and simple from a clinical standpoint," wrote Zoom Global Healthcare Lead Ron Emerson in a post about the announcement.  

WHY IT MATTERS

Cerner users at hospitals, health systems, physician offices and clinics will be able to launch secure Zoom visits directly within EHR workflows, the companies say.

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https://www.healthcareittoday.com/2021/12/02/could-2022-be-the-year-telehealth-breaks-out-of-its-silo/

Could 2022 Be The Year Telehealth Breaks Out of Its Silo? 

December 2, 2021

Anne Zieger

While telehealth use has made tremendous gains since the emergence of COVID, the technology still sits largely on the sidelines. Telehealth visits are now widely available, but the providers offering these visits aren’t adding new capabilities or even integrating the technology into their overall workflow.

In theory, telehealth consults could be enriched with health data gathered from countless other sources and used to give providers a more nuanced picture of the patient’s status, but in my experience as a patient, this never happens.

As a patient, I’d definitely love to see telehealth visits incorporate information gathered from other digital sources – notably remote patient monitoring devices – but the platforms my providers use seem far too limited to support this.

Don’t get me wrong, I’m delighted that telehealth is widely available in any form. As someone with multiple chronic illnesses, having remote access to my clinicians is a big deal in and of itself. Given that I see several specialists, I’m grateful that I don’t have to haul myself into their offices anytime I need something. I find it much easier to manage my health when I can be seen even if I don’t feel well enough to go out.

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https://mhealthintelligence.com/news/52-of-providers-say-patients-declined-telehealth-due-to-security-concerns

52% of Providers Say Patients Declined Telehealth Due to Security Concerns

A majority of the global providers surveyed also expressed concerns about data use and sharing, as well as about the personal penalties that may arise if data is leaked.

By Anuja Vaidya

December 01, 2021 - Though the popularity of telehealth has grown over the course of the COVID-19 pandemic, more than half of global telehealth providers have experienced cases where patients refused to participate in a virtual visit either because they do not trust the technology or due to privacy or data concerns, according to a new survey.

Commissioned by Kaspersky and conducted by Arlington Research, the survey includes results from 389 interviews, of which 170 were completed with enterprises that have more than 1,000 employees. The survey was conducted across 34 countries.

Survey results confirmed the widespread use of telehealth worldwide, with 91 percent of medical providers saying they have already started using telehealth. About 44 percent of respondents said they started using telehealth after the pandemic began, while 21 percent said they started using it less than a year before the onset of the public health emergency.

In fact, about 13 percent of providers have switched completely to online consultations on a regular basis and almost a half (46 percent) are likely to do so in the future.

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https://www.medpagetoday.com/opinion/happy-healer/95931

Three Antidotes to Patient Depersonalization

— Better patient-provider communication improves quality of care

by Neil Baum MD November 30, 2021

Imagine going to the doctor for your annual checkup, and the physician pulls out a chart or looks at the EMR of a different patient. Or picture the doctor discussing medications you're not taking and the results of tests you never had. These egregious mistakes would certainly not endear a patient to his or her doctor.

A study published in the Annals of Emergency Medicine found that patient identification mix-ups can happen easily, especially in emergencies, although they can happen in a variety of clinical settings. While most are caught early, nearly 10% cause harm to patients, according to ECRI (originally the Emergency Care Research Institute).

For example, among the most serious mistakes uncovered in the ECRI study was that of a healthcare team not attempting to resuscitate a patient in cardiac arrest because team members had pulled up the record of a different patient with a do-not-resuscitate order.

Clinical mistakes quickly diminish a patient's confidence in his or her physician and fuel a motivation to find a new provider. From my decades-long experience practicing urology, I can attest that building patient trust typically takes years, yet it takes just one problem or unpleasant experience to undo that hard-earned trust. Unfortunately, frustrated patients often place the blame on the physician -- even when it's not the doctor's fault.

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https://www.healthleadersmedia.com/technology/indiana-hie-innovates-er-while-teaming-five-other-hies-extend-reach

Indiana HIE Innovates in the ER While Teaming Up With Five Other HIEs to Extend Reach

Analysis  |  By Scott Mace  |   December 01, 2021

Indiana's largest health system is now using a FHIR app developed by the Indiana Health Information Exchange, providing emergency physicians with one-button data gathering for common symptoms.


KEY TAKEAWAYS

·         Pandemic gave birth to Consortium for State and Regional Interoperability, which stood up a six-state COVID dashboard in three weeks, with the IHIE as a founding member.

·         The IHIE's Network for Patient Care is the nation's largest clinical data repository, with data on more than 17 million patients.

·         The goal is to make health data interoperability more economical or attractive than unstructured data via fax machine image exchanges, which live on within the EHRs themselves.

As the oldest health information exchange in the United States, founded in 2004, the Indiana Health Information Exchange (IHIE) has provided a road map for other HIEs to follow. And as pandemics rage and physician burnout threatens to spiral out of control, the IHIE is more than just a pipeline in which for medical records to flow.

It operates the Indiana Network for Patient Care (INPC), the nation's largest interorganizational clinical data repository, with participation from more than 120 hospitals, 18,000 practices, and 50,000 providers. All told, it includes data on more than 17 million patients, at a time when interoperability remains a challenge nationwide.

The IHIE is also a member of the Strategic Health Information Exchange Collaborative, a national collaborative of more than 80 HIEs, which collectively serve 95% of the U.S. population.

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https://mhealthintelligence.com/news/best-buy-doled-out-400m-for-rpm-provider-current-health

Best Buy Doled Out $400M for RPM Provider Current Health

In its latest earnings call, Best Buy leaders not only disclosed the amount the company paid to buy Current Health, but also outlined its three-pronged healthcare strategy, which includes virtual care.

By Anuja Vaidya

November 30, 2021 - Best Buy's acquisition of remote care services provider Current Health made headlines back in October, and now the company's leaders have revealed the large price-tag behind the deal: $400 million.

In its third quarter 2022 earnings call last week, Matt Bilunas, Best Buy's chief financial officer, disclosed the amount the company paid to purchase Current Health and said the acquisition is expected to have "a slightly negative impact on our Q4 non-GAAP operating income," according to a transcript released by Seeking Alpha.

The retailer announced plans to buy Current Health last month. Current Health's platform integrates patient-reported data with information from biosensors, including the company's own continuous monitoring wearable device, to provide real-time insights into a patient's condition. This allows healthcare organizations to monitor patients remotely and coordinate in-home care through its service partners.

"The future of consumer technology is directly connected to the future of healthcare," said Deborah Di Sanzo, president of Best Buy Health, in an Oct. 12 news release. "We have the distinct expertise in helping customers make technology work for them directly in their homes and by combining Current Health's remote care management platform with our existing health products and services, we can create a holistic care ecosystem that shows up for someone across all of their healthcare needs."

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https://patientengagementhit.com/news/patient-provider-communication-misses-the-mark-on-medication-adherence

Patient-Provider Communication Misses the Mark on Medication Adherence

Cost is a key medication adherence barrier, but most patient-provider communication on the matter focuses on medication management, survey data shows.

By Sara Heath

November 30, 2021 - Cost, health insurance coverage, and the hunt for financial assistance programs prove the biggest hurdles to medication adherence, but new data shows that these barriers aren’t always part of patient-provider communication.

The Health Union survey of about 2,000 patients with chronic illness confirmed what many in the healthcare industry know to be true: the high price tag for drugs is keeping patients from achieving optimal medication adherence.

And not achieving that optimal medication adherence comes with negative consequences. Patients who are not able to take their medications as prescribed run the risk of seeing acute adverse health events that could land them in high-cost and high-acuity settings, like the emergency department.

This survey confirms the conventional wisdom that patients don’t skip doses because they are obstinate, but rather because they cannot afford their medications or face other cost-related barriers. Twenty-seven percent of surveyed patients said their biggest barrier to medication adherence was the cost of their drugs.

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https://www.healthdatamanagement.com/articles/fhir-offers-potential-to-automate-expedite-prior-authorization

FHIR offers potential to automate, expedite prior authorization

The emerging standard holds promise in helping payers and providers move patient information seamlessly to make care reimbursement decisions.

Nov 30 2021


Diana Manos

Proponents of Fast Health Interoperability Resources (FHIR) say the information exchange standard is a leading candidate to facilitate information exchange, particularly when it comes to efforts to remove the barriers that make prior authorization difficult.

In the midst of that effort is Tony Sheng, vice president of interoperability solutions for ZeOmega and member of HL7’s Da Vinci Project. At a recent Da Vinci Project community web-based meeting, Sheng and fellow Da Vinci member, Change Healthcare’s Craig Knier, demonstrated the use of FHIR and application programming interfaces (APIs) to enable real-time prior authorization between providers and payers.

The effort to incorporate FHIR to solve vexing prior auth challenges is significant because relatively few such communications between providers and payers are accomplished in even a partially automated way. Most of these intricate transactions are time-consuming, labor-intensive and put many patients at risk while they are waiting for their care to be approved, trade groups say.

Sheng said the use of FHIR and APIs to speed the prior authorization process is exciting and holds promise for things to come. But it’s not a silver bullet. In the long run, because “FHIR is just a set of standards,” he says. Providers still have to get all documentation necessary when it comes to compiling all the needed clinical evidence to get an authorization passed. 

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https://www.medpagetoday.com/opinion/patientcenteredmedicalhome/95920

Perfecting the Art of Nudging

— In a world full of reminder fatigue, how can we ensure patients get that needed test or vaccine?

by Fred N. Pelzman, MD November 29, 2021

After taking a couple of days off for the Thanksgiving holiday, I returned to find the usual stack of mail and faxes that needed going through, as well as a plump electronic medical record in-basket.

One of the letters I received in the mail struck me as sort of strange, and made me think about how we need to rethink so many things in healthcare. The letter started out with a large-font bolded message: "Action Requested." Then it had the usual amenity "Dear Test Provider: your patient has not completed the test you ordered for them. Our company has made several attempts to encourage your patient to perform this test. We encourage you to contact your patient directly to ensure your patient completes their test." [boldface theirs]

This was followed with some details about the test and the patient's identifying information. And then it wrapped up with, "Thank you for your help!" As if I don't have enough to do.

This had all started out during an office visit, when a patient and I went through the risks and benefits and alternatives of an item that had been quite delinquent on their healthcare maintenance. We decided on this particular test as a plan, and then I had done my part to set the process into motion. From that point on, it was up to the company to send them the test to perform at home, and up to the patient to ultimately do it and return it to the company so it could be processed. After that, it would once again have been my job to communicate the results of the test to the patient, and talk with them about the next steps that we needed to do to continue to keep them as healthy as possible.

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https://www.healthcareitnews.com/news/how-ai-bias-happens-and-how-eliminate-it

Global Edition

Artificial Intelligence

How AI bias happens – and how to eliminate it

A Stanford cardiologist and expert in artificial intelligence and machine learning explains where biased algorithms come from. He offers advice for preventing them and enabling improved decision support for better outcomes.

By Bill Siwicki

November 30, 2021 01:03 PM

Artificial intelligence holds great promise for healthcare, and it is already being put to use by many forward-looking hospitals and health systems.

One challenge for healthcare CIOs and clinical users of AI-powered health technologies is the biases that may pop up in algorithms. These biases, such as algorithms that improperly skew results because of race, can compromise the ultimate work of AI – and clinicians.

We spoke recently with Dr. Sanjiv M. Narayan, co-director of the Stanford Arrhythmia Center, director of its Atrial Fibrillation Program and professor of medicine at Stanford University School of Medicine. He offered his perspective on how biases arise in AI – and what healthcare organizations can do to prevent them.

Q. How do biases make their way into artificial intelligence?

A. There is an increasing focus on bias in artificial intelligence, and while there is no cause for panic yet, some concern is reasonable. AI is embedded in systems from wall to wall these days, and if these systems are biased, then so are their results. This may benefit us, harm us or benefit someone else.

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https://www.healthleadersmedia.com/payer/cms-repeals-final-rule-digital-therapeutics-year-shifting-guidance

CMS Repeals Final Rule on Digital Therapeutics in a Year of Shifting Guidance

Analysis  |  By Laura Beerman  |   November 29, 2021

"[T]he absence of an established, repeatable, and scalable path to commercialization and prescription of DTx has bottlenecked broader uptake," says one physician leader.


KEY TAKEAWAYS

·         The Centers for Medicare & Medicaid Services has repealed its Medicare Coverage of Innovative Technology final rule.

·         The action leaves multiple unanswered questions for digital therapeutic reimbursement, with payers using a patchwork of existing coverage, benefit, coding, and billing options.

·         It is a scenario not uncommon to healthcare innovation: building the bicycle while riding it—and many others.

On November 14, 2021, the Centers for Medicare & Medicaid Services (CMS) repealed its final rule on Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary. The repeal marks the fifth MCIT action in 2021 as Medicare, Medicaid, and commercial payers await guidance on digital therapeutics (DTx), including those that require a prescription. Until the regulatory dust settles, DTx commercialization will continue to develop—like so many healthcare innovations—in a "both/and" world, one in which stakeholders work within and around existing frameworks while attempting to forge new ones.

The CMS MCIT 2021 timeline began in January with a final rule that would have "automatically provide[d] Medicare coverage for devices receiving FDA breakthrough designation for four years," writes Health Affairs contributor and physician-investor Nisarg Patel. MCIT sought to close "the current nine- to twelve-month gap between FDA approval and Medicare National Coverage Determinations, as well as the inconsistent coverage by local Medicare administrative contractors."

Additional legislative and industry changes needed

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https://ehrintelligence.com/news/how-an-api-coordinated-data-sharing-for-clinical-research

How an API Coordinated Data Sharing for Clinical Research

A research concierge API connects public academic institutions with private hospitals to support data sharing for clinical research projects.

By Hannah Nelson

November 29, 2021 - The implementation of a research concierge application programming interface (API) has helped improve data sharing for clinical research across Virginia, according to a study published in JAMIA.

The integrated Translational Health Research Institute of Virginia (iTHRIV) is a collaboration between public academic institutions—the University of Virginia and Virginia Tech—and private hospitals—Inova Health and Carilion Clinic—that aims to promote inclusive clinical research through data sharing.

The iTHRIV Commons set out to provide participants with a cross-site scalable research infrastructure for the secure sharing, storage, and analysis of data in accordance with NIH FAIR (Findable, Accessible, Interoperable, and Reusable) principles.

The iTHRIV Research Concierge Portal is an API that serves as the front end to the iTHRIV Commons. The portal supports federated login, personalized views, and secure interactions with objects in the ITHRIV Commons federation.

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https://healthitsecurity.com/news/h-isac-releases-ciso-guide-for-identity-centric-data-sharing

H-ISAC Releases CISO Guide for Identity-Centric Data Sharing

H-ISAC released a guide to help CISOs navigate the 21st Century Cures Act by adopting an identity-centric data sharing approach.

By Jill McKeon

November 29, 2021 - Health-ISAC released new guidance to help CISOs navigate interoperability, patient access, and identity-centric data sharing under the 21st Century Cures Act. New interoperability mandates under the Cures Act require healthcare organizations to implement APIs to promote the digitization of electronic health information (EHI).

“While APIs are the ‘door’ to enabling interoperability of EHR between healthcare organizations, strong identity solutions are the ‘key’ that keeps EHI secure,” the guide explained.

Specifically, the Act depends on APIs that operate on the Fast Healthcare Interoperability and Resources (FHIR) standard. The FHIR standard was developed by nonprofit standards group Health Level 7 (HL7) and was created to allow patients to easily access data through a third-party application of their choice.

“These new interoperability mandates pose significant challenges, not the least of which is ensuring that new systems deployed to enable information sharing do not create new security concerns,” the guide stated.

“Digital identity is front and center in these new interoperability architectures, given the importance of ensuring that only the right people can access sensitive EHI.”

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https://www.bloombergquint.com/gadfly/patients-now-see-their-records-but-can-they-understand-them

Patients Now See Their Records, But Can They Understand Them?

Eliana Perrin 07:00 PM IST, 24 Nov 2021 12:35 AM IST, 24 Nov 2021

Save Patients Now See Their Records, But Can They Understand Them? (Bloomberg Opinion) –

I am a primary care pediatrician who often hears from friends or relatives when they get bad or confusing medical news. Recently, a call came late on a Friday from someone who had just checked a test result in her MyChart account, a widely used electronic patient portal, and learned she had cancer. The weekend was starting, she wouldn’t be able to discuss the news with her d\doctor until Monday, and she spent the weekend reading and rereading her report and anxiously searching the internet for information.

Experiences like this have become common since April, when a provision requiring the release of patient medical information was put into full effect as part of the 21st Century Cures Act. This legislation, originally from 2016, was a bipartisan effort to assurethat doctors and hospitals would share with patients (at no cost) several types of medical records and test results. While this may sound like a small step toward openness, it actually represents a sea change in the way doctors and patients communicate.

To be sure, doctors and health-care groups should always be willing to share health information with patients. Research has found transparency can strengthen doctor-patient relationships, and providing accurate information in a timely manner helps empower patients to improve their self-care.

But there are two problems — both rooted in the traditional practice of medicine: First, most providers write their lab and exam findings and other notes so that other medical professionals can understand them. That’s the point of most charts: to communicate to communicate complicated information among trained caregivers and billers. Patients, especially those with lower literacy, cannot easily interpret this language. Only one part, the after-visit summary, is written to and for the patient. Also, many patient portals aren’t available in Spanish or other languages, further limiting their accessibility and increasing health disparities.
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https://healthitsecurity.com/news/patients-file-lawsuits-in-wake-of-healthcare-data-breaches

Patients File Lawsuits in Wake of Healthcare Data Breaches

Some hospitals are successfully putting a stop to lawsuits filed in the wake of healthcare data breaches, claiming a lack of real injury to patients.

By Jill McKeon

November 29, 2021 - Healthcare data breaches may result in the exposure of protected health information (PHI) and personally identifiable information (PII), and victims are often advised to remain vigilant against suspicious account activity and consistently monitor their credit reports.

Although data breaches can be a cause for concern for impacted individuals, it can be difficult to prove financial harm or justify concern as a reason to seek damages.

Nonetheless, many hospitals face class-action lawsuits after suffering a ransomware attack, in which former patients may claim that the hospital or health system should have implemented proper safeguards to prevent the breach from happening.

UF Health Requests Dismissal of Patient Lawsuit

UF Health Central Florida filed a motion to dismiss a lawsuit that alleged that the health system was negligent and failed to prevent a May 31 ransomware attack that led to nearly one month of EHR downtime and impacted over 700,000 individuals, according to Villages-News.

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https://www.healthcareitnews.com/news/boost-interoperability-snomed-ct-power-ips-sub-ontology

In a boost to interoperability, SNOMED CT to power IPS sub-ontology

SNOMED International says it will create and release an openly available International Patient Summary sub-ontology in the first half of 2022, aimed at promoting cross-border information sharing.

By Kat Jercich

November 29, 2021 03:56 PM

SNOMED International announced this past week that its governance bodies had recently enacted a decision to support the scope of content within the International Patient Summary.

The organization said it will extend the core of SNOMED CT's structured clinical terminology in order to create and release an open, standalone IPS sub-ontology in the first half of 2022.

This, in turn, will support international data-sharing, said SNOMED International.

"2021 has seen increased interest by governments and health and care organizations globally for implementing the IPS to enhance timely cross-border health information flow and interoperability," said Alex Elias, chair of SNOMED International’s General Assembly, in a statement.

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https://www.healthcareitnews.com/news/emea/digital-health-apps-germany-update-diga-journey

Digital health apps in Germany - An update on the DiGA journey

Digital therapeutics have been on the German market for a year. Healthcare IT News explores the progress made, as well as future developments and their potential influence on other countries’ eHealth strategies.

By Cornelia Wels-Maug

November 29, 2021 06:13 AM

Digital therapeutics, or Digital Health Applications (DiGA), are apps for the detection, monitoring, treatment, or alleviation of medical conditions. The DiGA initiative is part of the 2019 Digital Healthcare Act (DVG) that sets the legal framework for doctors to prescribe DiGAs to the 73 million citizens insured with a statutory health insurer that reimburses their use,  and has been recognised as a pioneering approach globally. To classify as a DiGA, apps that are CE-marked as Class 1 and 2a low risk medical devices must have successfully passed the Fast-Track assessment process by the Federal Institute for Drugs and Medical Devices (BfArM). The assessment appraises an app with regards to its safety, performance, data protection, information security, medical effectiveness, interoperability, its ability to bring positive health effects and advance the healthcare system, among other things.

The first DiGAs were authorised for use in October 2020, and now a total of 24 are approved (as of 29 Nov 2021). So far, 106 applications were submitted, of which six were rejected and 52 withdrawn – on the grounds of inappropriate study design (42%) and inapt systematic data evaluation (42%). Currently 24 apps are under review. The approved DiGAs cover a range of medical fields including: cancer (2); cardiovascular system (1); ears (1); hormones & metabolism (3); muscles & bones & joints (3); nervous system (3) and psyche (11).

Initially, DiGA developers stemmed from the startup domain, but interest from medtech and pharma companies - as well as industry associations is increasing. The majority (86%) of applications are “made in Germany", with 10% of DiGA applicants based in other European countries and 4% in the US and New Zealand.

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Enjoy!

David.

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