This blog is totally independent, unpaid and has only three major objectives.
The first is to inform readers of news and happenings in the e-Health domain, both here in Australia and world-wide.
The second is to provide commentary on e-Health in Australia and to foster improvement where I can.
The third is to encourage discussion of the matters raised in the blog so hopefully readers can get a balanced view of what is really happening and what successes are being achieved.
Quote Of The Year
Timeless Quotes - Sadly The Late Paul Shetler - "Its not Your Health Record it's a Government Record Of Your Health Information"
or
H. L. Mencken - "For every complex problem there is an answer that is clear, simple, and wrong."
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
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September 02,
2022 - In the first six months of 2022, healthcare interoperability has
grown tremendously, according
to Surescripts, which says it has supported health data exchange for nearly
one-fifth of Americans.
Providers
used Surescripts Record Locator & Exchange to access health records for
more than 62 million patients. Additionally, more than 622 million
clinical documents were exchanged in the first six months of 2022, representing
a 76 percent increase over the same time period in 2021.
As technology
in healthcare settings becomes more prominent, so too has the need for robust
data security. As the way patient data is used and stored has moved away from
more analogue means such as paper filing systems, the approach to data security
must also change.
30 August,
2022
For Johan
Åtting, chief information security officer (CISO) at Sectra, security simply
cannot be an afterthought.
“A key
concept that we use at Sectra is ‘security by design and by default’, security
cannot be effectively added to a product or system afterwards, it has to be
within focus from the design of a product throughout the building, testing and
deployment of the product,’ he says.
“At Sectra,
security architects are involved from the very start of the design of a
product, and every development team has a security champion that ensures that
security is considered in every aspect of development and testing.”
Åtting goes
on to explain the importance of merging clinical and technological ideas – one
cannot have a securely designed piece of health tech if there has been no
clinical input. Put simply, it would render the technology moot.
When
hackers gained access to a large retailer’s computer network through scam
emails to employees, more than 900 store locations were affected, and 2 million
customers were impacted before the company was alerted by a security blogger
six months later. That led to several class-action lawsuits against the
company, attorney generals in multiple states opened investigations, and the
affected credit-card companies issued fines.
In
another case, a ransomware attack blocked all access to a regional accounting
firm’s computer system, and also deleted files. After ransom was paid, it took
several days to restore the applications and recover deleted files from a
backup. As a result, the firm was unable to meet tax-filing deadlines, causing
brand and reputation damage.
Then
there was a company that provides technicians to a laptop manufacturer’s repair
center. While a young woman’s laptop was in the custody of technicians at the
center, her Facebook account was hacked, and several sexually explicit photos
were posted to it. She negotiated a quick multi-million-dollar settlement with
the laptop manufacturer, which demanded, in turn, that the staffing company
compensate it for the privacy breach.
These
are only three of many real-life cases detailed by the Hartford Financial
Services Group as warnings that companies of any kind and any size are
vulnerable to cybercrime.
A study conducted by researchers from the CDC, CMS, and NIH found that the
use of telehealth and digital health tools to provide medication to people with
substance abuse issues and monitor treatment during the pandemic helped improve
adherence and lower the risk of a medically treated overdose.
A
new study led by the Centers for Disease Control and Prevention finds that
telehealth services used during the pandemic to help people dealing with
substance abuse improved treatment adherence and lowered the odds of a
medically treated overdose.
The
study, conducted by researchers from the CDC, Centers for Medicare &
Medicaid Services (CMS), and National Institutes of Health (NIH) and published in JAMA Psychiatry, focused on how healthcare
providers used medications for opioid use disorder (MOUD) during the pandemic
to treat some 175,000 Medicare beneficiaries.
Providers
took advantage of waivers enacted during the pandemic to prescribe three
medications – methadone, buprenorphine, and extended-release naltrexone - via
telehealth and manage care for their patients through a variety of channels,
including virtual care and audio-only telehealth (often via a telephone). These
waivers are currently scheduled to end when the national public health
emergency (PHE) is lifted sometime next year.
Last
year, organizations spent $2 billion on products that provide Endpoint
Detection and Response, a relatively new type of security protection for
detecting and blocking malware targeting network-connected devices. EDRs, as
they're commonly called, represent a newer approach to malware detection.
Static analysis, one of two more traditional methods, searches for suspicious
signs in the DNA of a file itself. Dynamic analysis, the other more established
method, runs untrusted code inside a secured "sandbox" to analyze
what it does to confirm it's safe before allowing it to have full system
access.
EDRs—which
are forecasted to generate revenue of $18
billion by 2031 and are sold by dozens of security companies—take an
entirely different approach. Rather than analyze the structure or execution of
the code ahead of time, EDRs monitor the code's behavior as it runs inside a
machine or network. In theory, it can shut down a ransomware attack in progress
by detecting that a process executed on hundreds of machines in the past 15
minutes is encrypting files en masse. Unlike static and dynamic analyses, EDR
is akin to a security guard that uses machine learning to keep tabs in real
time on the activities inside a machine or network.
Streamlining EDR evasion
Despite
the buzz surrounding EDRs, new research suggests that the protection they
provide isn't all that hard for skilled malware developers to circumvent. In
fact, the researchers behind the study estimate EDR evasion adds only one
additional week of development time to the typical infection of a large
organizational network. That's because two fairly basic bypass techniques,
particularly when combined, appear to work on most EDRs available in the
industry.
In May 2021,
I got a call I never expected. I was working on a book about A.I.
ethics, focused on the algorithm that gives out kidneys to transplant
patients in the United States. Darren Stewart—a data scientist from UNOS, the
nonprofit that runs the kidney allocation process—was calling to get my take:
How many decimal places should they include when calculating each patient’s
allocation score? The score is an incredibly important number, given it
determines which patient will get first chance at each donated organ. But still:
decimal places? Surely, I thought, this was a technical detail—a question for
the experts.
I quickly
discovered that I was wrong. The issue was ethical rather than technical, and
fascinating: The computers at UNOS could calculate each patient’s allocation
score out to 16 decimal places. And in some cases, for patients in very similar
situations, the system would need to carry things out to the umpteenth decimal
place in order to find a difference between two transplant patients and offer
an available organ to one rather than the other.
Given how
high the stakes are, why not use all the data you can and be as precise as
possible? To Stewart and his colleagues, that approach felt wrong. Past a
certain point, these extra digits of precision get so small that they stop
describing real medical differences between patients. A tiny difference in the
14th decimal place between Alice’s kidney score and Bob’s doesn’t
actually mean that Alice would do better with a transplant. At that point, the
score difference may just be a technical pretext for giving the organ to one
candidate instead of the other, a reason that may outwardly appear neutral and
objective, but is actually arbitrary.
Sequoia Project releases final QHIN application as it moves into
operational phase
The news
marks a "major milestone for TEFCA" said National Coordinator for
Health IT Micky Tripathi. Sequoia is also seeking stakeholder feedback for its
Data Usability Workgroup.
In
the most recent of what has been a series of policy releases these past few
months, the Sequoia Project on Thursday published some important final documents
on the road to TEFCA: Common Agreement standard operating procedures and the
application form for Qualified Health Information Network participation.
With
the new releases, ONC's recognized coordinating entity for the Trusted Exchange
and Common Agreement is "moving into the operational phase of TEFCA,"
said Mariann Yeager, CEO of the Sequoia Project, in a statement.
"Since
the release of the Common Agreement in January 2022, we’ve been working toward
hitting our promised timelines while seeking input from the community. The
feedback we received has been invaluable as we worked toward finalizing the
SOPs and application."
Drafts
of these documents were released earlier this summer for stakeholder feedback,
and both Sequoia and ONC have modified and updated the documents in response.
They are available on the RCE
website:
·Qualified Health Information Network
Application.
·Qualified Health Information Network Onboarding
& Designation SOP.
·Means To Demonstrate U.S. Ownership and Control
of a QHIN SOP.
·Means To Demonstrate U.S. Ownership and Control
of a QHIN SOP Questionnaire.
The
following is a guest article by Karen Maduschke, Sr. Director & General
Manager, Patient Consent at IQVIA.
In
the United States alone, 5 million people are admitted annually to intensive
care units (ICU), where they receive acute care and monitoring for active
emergencies. If they are a fit with the inclusion criteria, many of these
patients can be ideal candidates for receiving investigational treatments that
may save their lives while providing insights to researchers that could help
save the lives of countless future patients.
In
acute care settings specifically, the urgency of medical action can be keenly
felt by the patient, their families, and their care providers. For this reason,
the ability to provide the option for electronic informed consent (eConsent) to
join a trial in place of traditional paper-based process plays a pivotal role
in quickly enrolling the patient so that they may receive critical intervention
as quickly as possible. In turn, eConsent adoption can simultaneously enable
better clinical research as well as rapid delivery of potentially life-saving
cutting-edge treatments to patients with an immediate need.
The
Challenge of Informed Consent in the ICU
Clinical
research has long been highly valued within ICUs for researchers and patients. Still, obtaining
informed consent to participate in a clinical trial in these scenarios can be
challenging. Patients can be admitted to the ICU for any number of reasons,
such as a stroke, heart attack, organ failure, infection, or a major trauma.
Their need for care is time sensitive, meaning that getting rapid consent to
provide potentially life-saving interventions is essential. However, acute care
patients are often unable to provide consent on their own – for example if they
are unconscious, physically, or mentally impaired – and need a Legally
Authorized Representative (LAR) to step in on their behalf.
August 31,
2022 - Post-acute care providers want EHR platforms tailored for their
specific area but continue to face interoperability and care coordination
challenges, according to a KLAS
report.
No EHR vendor
has delivered solutions across the entire breadth of post-acute care settings.
Typically, organizations offer home- or facility-based care, so purchase
decisions are usually driven by one type of care.
MatrixCare
has achieved solid adoption across several post-acute care settings and
performs consistently well in home health, hospice, and LTC/SNF.
WellSky
offers tools for all measured care settings. However, adoption remains very low
in some environments, like LTC/ SNF.
ONC, HRSA Partner on Uniform Data System Interoperability Initiative
ONC and
HRSA are working on establishing a USCDI+ dataset to advance the
interoperability of HRSA’s Uniform Data System (UDS) and improve access to
health data.
August 31,
2022 - ONC and the Health Resources and Services Administration (HRSA)
have partnered on a new USCDI+ initiative to align HRSA’s Uniform Data System
(UDS) with interoperability standards, according to a HealthITBuzz
blog post.
ONC recently
launched the USCDI+ initiative to support the establishment of program-specific
datasets that will operate as extensions to the existing United States Core
Data for Interoperability (USCDI).
ONC and HRSA
are working to align the UDS with interoperability standards and transition to
patient-level reporting
requirements with USCDI.
“We are also
establishing a strategic direction aligned with ONC’s Cures Act Final Rule for
HL7 Fast Healthcare Interoperability Resources (FHIR)-based exchange to better
support the needs of health centers across the country,” ONC officials noted in
the blog post.
August 31,
2022 - A special
report published in Radiology: Artificial Intelligence last week
highlighted the practices that can lead to bias in artificial intelligence (AI)
and machine-learning (ML) models increasingly used in radiology and provides
strategies to mitigate these issues.
The report is
the first in a three-part series on the topic. Part one focuses on data
handling, part two
on model development, and part three on
performance evaluation.
In this first
installment, the authors state that 12 suboptimal practices occur during the
data handling process that can potentially lead to bias. In this report, data
handling is defined as “all data-related processes following the initial planning
for an ML study up to model development and training.”
Using this
definition, the researchers outlined a framework that divides data handling
into four steps: data collection, data investigation, data splitting, and
feature engineering. Within each step, there are three overarching practices
that have the potential to lead to biases, according to the authors.
August 31,
2022 - When properly implemented, zero
trust security strategies can help healthcare organizations bolster their
security efforts. However, the sector faces unique challenges surrounding IoT
devices and identity and access management that are worth considering when
contemplating zero trust in healthcare.
In a new white
paper, Health-ISAC provided guidance for healthcare CISOs to help them
understand and implement zero trust security strategies.
Zero trust as
a concept has existed for more than a decade, Health-ISAC explained, but it has
become even more popular in recent years. In 2021, President Biden issued
an executive order on the state of the nation’s cybersecurity and called out
the importance of zero trust initiatives. Now, federal agencies across the
country are rolling out zero trust architectures.
Additionally,
a recent report by Okta found that 58 percent of surveyed healthcare
organizations had started implementing
zero trust initiatives this year, compared to just 37 percent last year.
The potential reasons for this uptick in zero trust adoption largely point to
the volatility of the current cyber threat landscape. The healthcare sector has
had to adapt and embrace innovative methods of securing its systems in order to
appropriately counter cyber threats.
Barriers
to accessing care are being addressed virtually.
When the
pandemic forced medical providers to find creative ways to see patients,
telehealth provided an answer.
But as the
pandemic has receded, telehealth services — which include video chats as well
as phone calls — are solving long-standing problems with access to healthcare.
It allows patients to see a doctor from wherever they are, increasing access in
spite of life’s circumstances.
Dr. Justin
Zaghi, chief medical officer at Heal, a company that self-advertises “primary care in the comfort of
your home, covered by Medicare” has witnessed telehealth both before and
during the pandemic. “Prior to the pandemic, telemedicine was really a
miniscule part of the care delivery model,” said Zaghi, whose company expanded
operations to Georgia in 2019. “What the pandemic did is that it accelerated
the adoption of telemedicine across our practice.”
According to a briefing on national telehealth use in 2021 released in
February by HHS, one in four of nearly 700,000 respondents said they had
used telehealth services in the previous four weeks. Telehealth use was highest
among those under Medicaid and Medicare, Black respondents, and those earning
less than $25,000.
TUESDAY, Aug.
30, 2022 (HealthDay News) -- Every year, anywhere from 700,000 to 1 million
people fall while in U.S. hospitals, and this often triggers a
downward health spiral.
Little has
been shown to make a dent in those numbers. Until now.
Enter Smart
Socks, which are wired with sensors that send an alert when a patient tries to
get up from a hospital bed and puts pressure on the socks.
In a 13-month
study, nobody who wore the socks fell, which equaled a rate of 0 falls per
1,000 patient-days. Patient-days refers to the number of falls and the number
of occupied bed days on a hospital unit over a study period. Historically, this
rate is 4 falls per 1,000 patient-days.
HL7 has launched a new effort,
GenomeX, to advance the interoperability of genomic data through the use of its
Fast Healthcare Interoperability Resources, or FHIR, standard.
The new GenomeX “community” will
develop and promulgate ways to use FHIR to improve access to patients’ genomic
information. The initiative is a new domain under CodeX.
CodeX is a FHIR accelerator that aims to speed up the development of
interoperable data modeling and applications to improve patient care and
research in oncology, cardiovascular medicine and, now, genomics.
"The use of FHIR to support
data exchange could lead to wider use of genomic data for medical research and
easier inclusion of data in electronic health records for precision patient
care."
Steve Bratt,
leader of health standards and interoperability, MITRE
The use of genomic information in
healthcare is rapidly growing as genomic sequencing becomes more widely
available. However, the huge amount of data derived from tests is not easily
exchanged between testing labs, which primarily use proprietary systems or
older HL7 standards, such as HL7 Version 2.
Southcoast Health slashes CHF and COPD readmissions rates with telehealth
and RPM
Remote
patient monitoring and visiting nurses, triage telehealth for the ER, boosting
behavioral health with telepsychiatry – Southcoast is deep into virtual care.
Southcoast
Health System, based in New Bedford, Massachusetts, has employed a multipronged
approach to solving different issues through telemedicine.
THE
PROBLEM
While
early goals involved keeping care accessible and safe during the pandemic,
staff have worked to focus on continuous improvement and adding programs that
would build for long-term value in care delivery.
"One
of the first telemedicine solutions we utilized involved tele-triage to reduce
PPE demands in our emergency departments and ensure patients were directed to
the appropriate level of care," recalled Jim Feen, senior vice president
and chief digital and information officer at Southcoast Health System.
"Patients seen this way showed a variety of symptoms and this method
helped decide which cases may be more appropriate for an urgent care setting or
perhaps even a referral back to primary care.
"There
were automations built within our existing Microsoft Teams platform that allowed
for seamless tele-triage screenings to be initiated by triage nurses in our
ED," he continued. "We have other use-case scenarios."
The continuing evolution of physician specialist IT
What do
physician group EHRs need to include over the next decade? What are differences
between GP and specialist systems that must be considered as the technology
evolves? One expert offers advice.
When
meaningful use incentive dollars began being disbursed to specialty medical groups
back in 2010, providers quickly implemented new practice management and
electronic health record systems.
Fast
forward 12 years and specialty practices now are replacing those legacy systems
with next-generation platforms. Today, specialty practices are faced with many
of the similar "legacy versus new" challenges that hospitals faced a
decade ago, but there are lessons learned that practices can pull from to help
inform these decisions.
Bill
Lucchini is CEO of Nextech Systems, a vendor of EHR and practice management
technologies for ophthalmology, dermatology and plastic surgery
practices. The vendor serves 4,000 medical practices nationwide.
Healthcare
IT News interviewed Lucchini to discuss gaps between legacy EHRs
implemented by physician practices and today's technologies. He discussed what
EHRs implemented by physician groups need to include over the next decade, and
the differences between general practice physician and specialist systems that
need to be considered as EHR technology evolves.
August 30,
2022 - Health IT vendor Surescripts has
become a strategic business and technology partner to Civitas Network for
Health to drive clinical interoperability for better patient care quality and
lower healthcare costs.
Civitas
Network for Health supports interoperability through widespread collaboration.
The organization comprises member organizations working on using health
information exchange, health data, and multi-stakeholder, cross-sector
approaches to improve healthcare.
“Civitas
Networks for Health is excited to have Surescripts join our national network,”
said Lisa Bari, Interim CEO of Civitas. “We are raising the voices of local
health collaboratives and those providing critical services to support health
transformation.”
“From the
secure exchange of life-saving data to the accountability of multi-stakeholder
initiatives, our member organizations have built the most trusted, connected,
and inventive programs to serve their communities,” Bari stated. “Surescripts
has long been a leader in healthcare interoperability, and their partnership is
invaluable as we continue improving the delivery of quality healthcare at lower
costs to patients.”
Experts Call for More Randomized Controlled Trials of Clinical AI
Experts
have found a lack of randomized controlled trials evaluating AI-assisted tools
integrated into clinical practice, which may impact how researchers quantify
the clinical benefit of these tools.
August 30,
2022 - In a new systematic review
published in the Journal of Medical Internet Research, researchers concluded
that randomized controlled trials (RCTs) evaluating artificial intelligence
(AI)-assisted tools integrated into clinical practice are limited in number and
scope and that more of these trials are needed to advance the role of AI in
medicine in the future.
However,
experts have also raised concerns
about its use as its popularity has grown. Some issues arise outside of the
technical applications of AI and are related to the data used rather than the
algorithms. This is a common challenge for those wishing to apply
AI to medical imaging, for example. Other issues stem from the way
algorithms are designed, like algorithms that unintentionally
perpetuate racial bias.
The issue
highlighted in this study belongs to a third category, which is related to
clinical readiness and validation of AI models. The researchers here aimed to
review all published RCTs of AI-assisted tools to characterize their
performance in clinical practice. This information is often used when
considering the clinical relevance of these tools, which has the potential to
influence the larger role of AI in medicine, according to the study.
FTC Sues Data Broker, Condemns Improper Data Privacy Practices
The FTC
underscored its commitment to fighting against improper location and health
data privacy practices in a recent lawsuit against data broker Kochava.
August 30,
2022 - The US Federal Trade Commission (FTC) sued
data broker Kochava over its alleged sale of geolocation data, signifying the
Commission’s commitment to cracking down on improper location and health data
privacy practices after the fall of Roe v. Wade.
The FTC
alleged that the data broker knowingly sold geolocation data that could be used
to trace individuals to sensitive locations, such as reproductive health
clinics, domestic violence shelters, and places of worship.
“The FTC
alleges that by selling data tracking people, Kochava is enabling others to
identify individuals and exposing them to threats of stigma, stalking, discrimination,
job loss, and even physical violence,” the FTC stated in a press release.
Cyber crooks
steal medical information of tens of millions of people in the U.S. every year,
a number that is rising fast as health care undergoes its digital
transformation.
It leads to
millions of dollars in losses for hospitals, insurers and other health care
organizations, threatens care delivery and exposes patients to identity theft.
But the
Department of Health and Human Services’ Office for Civil Rights, which is
tasked with investigating breaches, helping health care organizations bolster
their defenses, and fining them for lax security, is poorly positioned to help.
That’s because it has a dual mission — both to enforce the federal health
privacy law known as HIPAA and to help the organizations protect themselves —
and Congress has given it few resources to do the job.
“They’re a
fish out of water … They were given the role of enforcement under HIPAA but
weren’t given the resources to support that role,” said Mac McMillan, CEO of
CynergisTek, a Texas firm that helps health care organizations improve their
cybersecurity.
Health
systems are using digital health tools and the electronic health record to
not only monitor staff health and track compliance, but give employees an
avenue to manage their wellness and connect with supervisors.
KEY
TAKEAWAYS
·Occupational health concerns account for roughly
$171 billion in annual healthcare costs and range from illnesses and viruses to
behavioral health concerns and substance abuse issues.
·Prompted in part by the pandemic, which
highlighted the importance of monitoring employee health, healthcare
organizations are using the EHR platform and digital health technology to track
employee health and give staff a platform to manage their wellness and
communicate with supervisors.
·Some health systems and businesses are even
using virtual care platforms and wearables to monitor health concerns and give
employees on-demand access to care and resources.
Healthcare
organizations accustomed to using digital health for clinical care are finding
value in these services for occupational health. Some are using technology
platforms to help staff track their health and wellness and keep up with
testing and vaccination protocols.
Atrium Health Wake Forest Baptist,
based in Winston-Salem, NC, is running its occupational health program through
a custom-built electronic health platform developed through a partnership with
Enterprise Health. The platform gives administrators insight into employee
compliance and engagement rates, while streamlining the communication process
and allowing interactions through mobile devices and an online portal.
August 29, 2022 - As the drug overdose crisis continues to
grow, an interactive tool from CDC
and ONC aims to improve opioid prescribing by helping support Prescription Drug
Monitoring Program (PDMP) EHR integrations.
“Clinician use of PDMPs is a promising state-level intervention to
improve opioid prescribing, inform clinical practice, and support safer and
more effective patient care,” ONC officials Lolita Kachay, Jawanna Henry, and
Wes Sargent wrote in a HealthITBuzz blog post.
“Integrating PDMP data into EHR systems addresses barriers to
accessing and using PDMP data to help inform clinical practice to improve
opioid prescribing,” they explained.
The Integration Framework from CDC and ONC provides guidance on
project execution, management, and communication for successful integrations
and contains the following resources:
Amazon
Care may be done, but that's not the end of Amazon's bold healthcare ambitions,
industry watchers say.
The
online retail giant revealed plans last week to shutter
Amazon Care, its in-house business providing virtual and in-person medical
services. The business launched in 2019 as a pilot project and then quickly
expanded its telehealth services to all 50 states. In-person medical services,
typically offered at patients' homes, were offered in seven major cities.
Amazon was expected to roll out its hybrid care model to 20 additional
cities this year.
"We’ve
determined that Amazon Care isn’t the right long-term solution for our
enterprise customers," Neil Lindsay, senior vice president of Amazon
Health Services, said in an email to employees last week. "Although our
enrolled members have loved many aspects of Amazon Care, it is not a complete
enough offering for the large enterprise customers we have been targeting, and
wasn’t going to work long-term."
Lindsay
said the decision to end the program had been under consideration for “many
months” and that Amazon Care will stop operating at the end of 2022.
Amazon's
decision to shut down Amazon Care, which works with about half a dozen
employers, comes one month after the company announced a $3.9
billion deal to buy primary care provider One Medical, a company that works
with more than 8,000 employers.
Electronic
health record user mastery by nurses has seen a sharp decline since the
beginning of the COVID-19 pandemic, according to researchers.
WHY IT
MATTERS
Nearly
16,000 nurses across 35 healthcare organizations responded to a survey about
their EHR experience, with results found in KLAS Research's Arch
Collaborative Nursing Guidebook 2022. Those results showed a significant drop,
with just 59% of nurses surveyed in 2022 finding ongoing training helpful
compared with 71% of those surveyed in 2020.
The
urgency to build user mastery is clear, said KLAS researchers.
Nurses
in radiology, pediatric and newborn intensive care units and procedural and
behavioral health environments reported struggling with the EHR "and tend
to disagree [that] their EHR has the functionality they need," according
to the guidebook.
Nurses
in these areas would particularly benefit from improved onboarding, ongoing
training, inclusion in governance and heightened communication efforts.
The
eHealth-based Bavarian Alternative Detection of Atrial Fibrillation (eBRAVE-AF)
trial asked older adult members of one German health insurer to use a
smartphone app that measured pulse irregularities using the phone's camera
button and then wear a 14-day electrocardiogram patch in order to
engage at-risk patients to seek a doctor's treatment.
WHY IT
MATTERS
Afib
is the most common heart rhythm disorder and is often hard to diagnose due to a
lack of symptoms.
While
previous studies tested the potential of smart devices for large-scale Afib
screening, they made no comparison with conventional screening – symptom
evaluation, ECGs and other methods – according to the European Society of
Cardiology announcement.
The
eBRAVE-AF researchers invited adults aged 50 to 90 years old who were at risk for
stroke but had not experienced any major adverse cardiac and
cerebrovascular events and who owned smartphones to participate.
Participants had
no known atrial fibrillation, no oral anticoagulant prescriptions and a
CHA2DS2-VASc score (a scoring methodology based on several factors that would
increase the risk of stroke) of ≥1 men and ≥2 in women.
Newest Digital Health Programs Address Digestive Disease Management
August 29, 2022
The
following is a guest article by Bill Snyder is CEO of Vivante Health.
More
than 70 million Americans suffer from a wide gamut of digestive diseases, but
until recently few digital health solutions were available to help them manage
their conditions. There are smartphone apps for tracking everything from
exercise, sleep and calorie consumption to blood pressure, COVID-19 symptoms
and even diabetes management, but gut health has largely been left in the
digital dust – in part because there is no one-size-fits-all solution for a
category spanning so many different disorders.
Today
that’s changing as health tech companies begin to tackle the toll that chronic
digestive disease takes on patients, productivity and healthcare costs.
Reducing
Medical Spend & GI Symptoms
On
the patient side, the havoc wreaked by GI disease includes debilitating effects
like nausea, constipation and diarrhea as well as a staggering 8.3 million
emergency room visits annually for digestive complaints. (Abdominal pain is the
#1 cause of acute ER admissions.)
On
the medical spend and productivity side, the toll includes $136 billion in
annual medical claims – exceeding the total healthcare bill for trauma, mental
health and even heart disease – along with a per-person cost of up to $72,000
in yearly prescription drugs and up to 35 days of absenteeism per year. GI
issues are also among the top five healthcare expenses for many companies.
The
Federal Trade Commission has filed a lawsuit against Kochava, an Idaho-based
digital health company whose data analytics platform can be used to, among
other things, identify and track women seeking an abortion and abortion
providers.
Federal
officials are taking proactive steps to ensure that data on digital health
platforms can’t be used to identify women seeking an abortion.
The Federal
Trade Commission is wading into the hot-button issue with a lawsuit filed
against Kochava, an Idaho-based provider of mHealth app analytics and
attribution. The suit alleges that the company has customized its data feeds to
allow interested parties to identify the location and identity of mHealth app
users through unique device identification numbers and geolocation data,
thereby allowing them to target women visiting healthcare provider offering
abortion services.
“Where
consumers seek out healthcare, receive counseling, or celebrate their faith is
private information that shouldn’t be sold to the highest bidder,” Samuel
Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. “The FTC is taking Kochava to
court to protect people’s privacy and halt the sale of their sensitive
geolocation information.”
In its complaint, the FTC alleges that the company isn't
protecting data from mobile apps and devices, "allowing anyone with little
effort to obtain a large table of sensitive data and use it without
restriction." Using a week's worth of data collected from more than 61
million mobile users by the company, the agency said it was possible to identify
and track people in such sensitive places as reproductive health clinics,
places of worship, homeless and domestic violence shelters, and addiction
recovery centers.
Consumers
have a growing list of expectations when communicating with companies – and
healthcare is no exception.
Many patients
expect to have easy access to their personal health information at any time and
from anywhere. They demand to gain access in a variety of ways, including via
text messages, emails, websites, chats and phone calls.
Unfortunately,
some patients may not realize that many of the ways they’re used to
communicating in their personal lives are unsafe for sharing PHI.
Healthcare
organizations need to understand the potential risks of each communication
channel as well as their data privacy and security obligations under HIPAA.
Here’s a look at key issues for each channel.
Who is at fault when medical software gets it wrong?
Clinical decision support software is beneficial but if it
malfunctions, a doctor’s duty of care likely makes them liable
By Dr Megan
Prictor, University of Melbourne
August 4,
2022
Doctors are
being increasingly encouraged to rely on digital technology to guide care, but
who carries the blame if doctors rely on software that makes mistakes, leading
to patient harm?
Imagine this.
A patient has recovered enough from a heart attack to be discharged from
hospital. The presiding doctor sorts out the discharge using a hospital
computer that has clinical decision support software, which compares the
patient’s data with inbuilt algorithms to make recommendations for their care.
Clinical
decision support tools are increasingly used throughout our healthcare system
to promote high-quality care aligning with evidence and guidelines.
In this case,
the software generates a pop-up alert recommending that the doctor prescribe a
specific medication on the basis that the patient isn’t already taking it. The
doctor prescribes the medication, and the patient goes home. A few days later,
they die. An investigation finds that the patient had twice the recommended
amount of the medication in their system.
It turns out
the patient was already taking a dose of this same medication in a tablet that
was combined with another drug. As a result, because of the new prescription,
the patient had actually been taking a double dose of the medication, which
proved to be fatal.
Information
about the other medication the patient was already taking was in their medical
record, but the clinical decision support tool was flawed – it didn’t recognise
the existing medication the patient was on as being in the same category as the
newly-prescribed medication.
The doctor
was well aware of the rule against combining both medications but had relied on
the computer alert. Who is responsible under the law for the patient’s death?
A scenario
like this isn’t far-fetched; in fact, it’s based on one story in a recent study of
flawed clinical decision support software that led to patient harm.
The person
responsible for the mistake should bear responsibility for the harm. But who,
in a situation like this, was really responsible? Was it the software company
that created the flawed product and didn’t test it properly? Or was it the
doctor, who should have realised the alert was wrong and overridden it?
As a legal
academic, I have been working with a University of Melbourne team developing a
new clinical
decision support tool. I was interested in where a patient would find a
legal remedy if they were harmed in this type of situation, and who they could
hold accountable.
The doctor
could also be harmed in some ways too; for instance, they could face
disciplinary action and develop mental health problems. Their job may be at
risk.
My newly
published research into Australian law has found that most of the legal
risk is faced by the doctor and not the software developer. This is because
doctors have a fundamental duty of care to their patients, which they can’t
delegate to a computer when the computer is only providing recommendations and
not independently carrying out decisions.
Clinical
decision support software is designed to have a human in the decision-making
chain; it’s intended that a doctor will use their own judgment about whether to
follow each software alert. As a result, it’s quite likely that the doctor in
the story would be found to have acted negligently, breaching their duty of
care.
The doctor
might also be liable under Australian
Consumer Law for not providing services with ‘due care and skill’ (section
60).
To me
thereal takeaway is that the legal
researcher finds that when a piece of software’s advice is followed that “Australian
law has found that most of the legal risk is faced by the doctor and not the
software developer”. I find this a pretty sobering finding and one that should
be better known by clinicians.
The research
makes it clear the clinician needs to carefully assess any advice offered by a
CDS and carefully check the basis on which the advice is based!
Sobering
stuff I reckon but not out of line with the view that ultimate responsibly for
their recommended treatment!