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FDA Makes Medical Device Data Easier to Access, Use
SEP 4, 2015 7:48am ET
The Food and Drug Administration is making it easier for software developers and researchers to access and use data covering the entire medical device product life cycle.
Expanding on the availability of the agency’s databases of medical device-related adverse events and recalls, the openFDA initiative now includes current data on device classification (6,000 records), 24,000 registrations of device companies/establishments, and the companies’ listings of more than 100,000 devices.
In addition, nearly 40 years-worth of data is now available on openFDA including 30,000 device premarket approvals/approval supplements and 141,000 device clearances through premarket notifications and granted de novo requests. The agency also added more details about device recalls (9,500 records going back to 2002) and adverse event reports (4.2 million records since 1991).
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Saturday, September 05, 2015
- Inside Science TV
Heat Sensing Tattoo That Monitors Your Health
A new improved tattoo for a new improved you.
Originally published:
Sep 3 2015 - 3:30pm
By: Marsha Lewis, Contributing Producer
(Inside Science TV) – Tattoos come in all shapes and sizes. A new kind of temporary tattoo could become a kind of health monitor.
“We think about it as a second skin layer,” said John Rogers, a materials scientist and physical chemist at the University of Illinois at Urbana-Champaign.
Temporary tattoos recently have surged in popularity, as companies like Tattly add hefty doses of high design. But instead of just art — this tattoo is also science!
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Survey: CHIME Members Prioritize EHR Optimization
September 3, 2015 by Rajiv Leventhal
Seventy percent of responding College of Healthcare Information Management Executives (CHIME) members say that projects that will help them realize the value of their electronic health record (EHR) will be a top priority in the next year, according to a new survey from Impact Advisors.
The survey results were integrated in Impact Advisors’ latest white paper, “Realizing Value from an Enterprise EHR Investment.” The consulting firm conducted a survey to get a better understanding of how healthcare organizations are attempting to realize more value from their EHR. This primer outlines the survey results collected from more than 40 CHIME members, giving an insight into how market leaders are approaching optimization. Some other key findings include:
- Only 8 percent of respondents are NOT focused on optimization right now.
- Nearly 75 percent site “other priorities” as one of the biggest challenges currently.
- Almost three-quarters plan to seek outside assistance from a services firm in addition to leveraging an internal projects team.
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COPD Patients Benefit from Using Telemedicine App
SEP 2, 2015 8:29am ET
Patients with Chronic Obstructive Pulmonary Disease, who used a telemedicine-based app to report their daily symptoms and received same-day treatment recommendations from their provider, experienced fewer and less severe COPD exacerbation symptoms as well as an improvement in daily symptom control, lung function, and activity status.
That’s the conclusion of a two-year clinical study conducted by Temple University Health Systems’ Lung Center in Philadelphia and published in the journal Telemedicine and e-Health.
In the Pennsylvania Study of COPD Exacerbations (PA-SCOPE), patients using the app were able to report their respiratory symptoms and peak expiratory flow measurements, which were assessed by a computer algorithm and compared with initial values to achieve a symptom deviation score—a measure of how serious the symptoms are relative to the patients’ baseline metrics. Scores 1 or more points above the initial score generated an “alert” and patients were reviewed by a nurse and referred to a physician who prescribed treatment.
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Epic, athenahealth grow with zero losses
Posted on Sep 03, 2015
By Bernie Monegain, Editor-at-Large
Epic, Cerner and athenahealth were the only EHR vendors to post a gain in market in 2014. Morevover, competitors Epic and athenahealth alone held fast to their market share in 2014.
Of the nine EHR vendors KLAS reviewed, both athenahealth and Epic recorded zero clients moving away from their EMRs.
In the new report – Acute EMR Market Share: How Did My Vendor Fare? – KLAS noted that although the number of acute care hospitals making a decision about an EMR dipped in 2014, 240 organizations still selected an EMR.
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CCGs must plot IT roadmaps by April
2 September 2015
Clinical commissioning groups must submit digital roadmaps to NHS England by April next year, outlining how they will “eradicate the use of paper in the treatment of patients across all health and care services in their region by 2020.”
Guidance on the roadmaps will be released at NHS Expo in Manchester tomorrow, by NHS England’s director of patients and information Tim Kelsey.
This will include a new set of key digital standards that healthcare providers must implement as part of their standard NHS contract.
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Handbook 'to define interoperability'
2 September 2015
An interoperability handbook and procurement guide will be released tomorrow to help clinical commissioning groups write their digital roadmaps and healthcare providers achieve the vision of interoperable patient records.
Inderjit Singh, NHS England's head of enterprise architecture, said at the NHS Expo in Manchester today that the interoperability handbook will support CCGs in preparing their plans for going paperless by 2020, which need to be submitted by next April.
Singh said these roadmaps will define and articulate where CCGs want to get to and a new ‘digital maturity index’ will define where they are now. The handbook is intended to help them get between these two places.
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Doctors voice concerns over plan for greater patient access to medical records
Misgivings about safety and confidentiality over Jeremy Hunt’s plans to enable patients to access GP record via smartphone and to add information themselves
Thursday 3 September 2015 05.28 AEST Last modified on Thursday 3 September 2015 05.53 AEST
The health secretary, Jeremy Hunt, has announced plans to give patients in England access to their entire medical record by 2018, and to let them read and add to their GP record using their smartphone within a year.
The announcement at NHS England’s annual conference in Manchester prompted fears of a repeat of last year’s row over care.data, a programme in which patient records were shared outside the NHS without their consent. The opposition forced NHS England to halt the scheme temporarily while it addressed the concerns.
Phil Booth, coordinator of the campaign group MedConfidential, said: “Shoving highly sensitive information to patients via their smartphones really won’t help doctors treat them in 2016, and medical bodies like the Royal College of GPs have already pointed out it could expose the vulnerable to stalking, abuse and coercion, not to mention predatory companies who can’t wait to get their hands on such valuable data.”
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FDA clears new stethoscope for new age
Posted on Sep 02, 2015
By Bernie Monegain, Editor-at-Large
The FDA has cleared Eko Core, a digital stethoscope designed by medical devices startup Eko Devices. Company founders call Eko Core "a next-generation" stethoscope – billed as the only one on the market to wirelessly stream heart sounds to a HIPAA-compliant smartphone app. It is also the first to integrate heart sounds directly into the patient's EHR.
The value proposition? It enables clinicians to better address a cardiovascular disease crisis that affects one in four people worldwide.
Eko Core is also the only stethoscope available that enables clinicians to switch between analog and digital modes, according to company executives. The Bluetooth-connected mobile app, available on the Apple App Store, enables clinicians to view a heart sound waveform, save heart sounds directly to a patient's electronic health record and securely collaborate with a cardiologist for a second opinion.
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Black Book: Greenway tops EHR vendors for primary care doc satisfaction
September 1, 2015 | By Marla Durben Hirsch
Greenway Health is now the top-ranked electronic health record vendor for customer satisfaction among primary care physicians, edging out Practice Fusion, according to a new report from Black Book Rankings.
The six-month poll of implemented EHR users, announced Aug. 31, found that Greenway ranked first across all surveyed primary care EHR systems. Greenway ranked second behind Practice Fusion in 2013 and 2014. Greenway also received the highest customer satisfaction scores in the primary care subsets of general practice and family practice, and scored best among primary care physicians for system patient health data management and administrative processing, as well as order entry and management.
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Researchers: 'Community Vital Signs' Can Be Simple Part of EHR
August 31, 2015 10:02 am News Staff – As family physicians face growing pressure to collect data on patients' social determinants of health, a group of researchers suggests there is a simple path: pulling "community vital signs" into electronic health records (EHRs) using only patients' addresses.
In a paper titled "'Community Vital Signs': Incorporating Geocoded Social Determinants Into Electronic Records to Promote Patient and Population Health,"(jamia.oxfordjournals.org) published recently in the Journal of the American Medical Informatics Association, researchers advocate incorporating publically available community-based data directly into patients' EHRs.
Andrew Bazemore, M.D., M.P.H., director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care, was the lead author of the commentary, which is based on ongoing tests with partners at the OCHIN health information network and Oregon Health & Science University in Portland.
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Study finds tracking tools too challenging for elderly, those with multiple conditions
Beth Walsh
Aug 31, 2015
If providers want the elderly and those with chronic conditions to adopt mobile health tools, developers will need to make the tools more convenient and easier to use, according to a study published in the Journal of Medical Internet Research .
Researchers from Weill Cornell Medical College and Laval University in Quebec interviewed 22 patients with multiple chronic conditions and seven providers about health data tracking habits. The average age of the patients was 64, and they had an average of 3.5 conditions, including chronic pain, depression, heart disease and type 2 diabetes.
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AHRQ Funds Target Research, IT Tools to Improve Patient Safety
The Agency for Healthcare Research and Quality is making millions of dollars available for ambulatory care and long-term care facilities to research strategies to improve patient safety through information technology and other evidence-based tools.
The purpose of the new funding opportunity announcement is to support investigative research projects that examine the epidemiology of patient safety in these environments, gather evidence on strategies that can improve safety and develop tools to implement the strategies, according to AHRQ.
The total amount of funding and number of awards are contingent on AHRQ appropriations and submission of sufficient “meritorious” applications.
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EHR Clinic Notes Need to Be Redesigned
SEP 1, 2015 7:34am ET
University of Missouri researchers are calling for the redesign of electronic health record documentation tools to better meet the needs of primary care physicians, specifically the clinic notes sections that recap a patient’s medical history.
“While EHRs have granted physicians access to more information than ever before, they also include lots of extraneous information that does not contribute to the care of the patient,” said Richelle Koopman, M.D., associate professor of family and community medicine at the MU School of Medicine and lead author of a study published in the Journal of the American Board of Family Medicine.
In the study, researchers observed primary care physicians using EHRs in preparation for patient visits and asked them to identify which parts of the clinic note they found most and least important. According to the results, doctors overwhelmingly found the “assessment” and “plan” sections of the clinic notes to be the most important, while the “review of systems” section—which is required by Medicare and Medicaid for billing purposes—was deemed the least valuable.
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The case for clinical practice interoperability
Posted on Sep 01, 2015
By Michelle Troseth, Elsevier
The healthcare system demands enhanced care coordination and collaboration in response to value-based reimbursement, population health, patient engagement, integration and an expanding continuum of care. To accomplish these things, healthcare leaders must invest in interprofessional care, clinical integration and evidence-based practice, and integrate the perspectives and practices of every healthcare professional – physicians, nurses, allied health professionals and non-healthcare providers engaged in prevention and care management.
Building the pillars of interoperability
Technology alone can never generate healthcare change and transformation. Instead, executives and clinicians must focus on delivering the right information at the right time to care for consumers and patients with both simple and complex conditions.
Technology alone can never generate healthcare change and transformation. Instead, executives and clinicians must focus on delivering the right information at the right time to care for consumers and patients with both simple and complex conditions.
Doing so demands that executives and clinicians integrate the pillars of clinical practice interoperability that "live" with health information systems. Among the strategic priorities for executives and clinicians:
- Implement evidence-based care planning and documentation.
- Deliver timely clinical reference content to empower patients, consumers and providers.
- Increase engagement via mobile health devices-- before, during and after episodes of care.
- Develop and share patient stories that connect episodes of care and daily activities.
- Rely on evidence-based order sets.
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Argonaut Interoperability Project Focuses on Testing
AUG 31, 2015 7:36am ET
The Argonaut Project has entered Phase Two of its efforts to accelerate development and adoption of Health Level Seven International’s Fast Healthcare Interoperability Resources (FHIR), an interoperability framework leveraging the latest web standards.
Many industry stakeholders are looking to FHIR—with its RESTful application programming interfaces (APIs) and OAuth-based security—as a solution to the complex challenge of health IT interoperability. They argue that RESTful APIs in particular, which are already widely used in other industries based on open/consensus-based standards, have the potential to serve as the core functionality to support data access in healthcare, becoming the enabler for health information exchange.
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The Best Health IT Book of 2015
Scott Mace, for HealthLeaders Media , September 1, 2015
The Digital Doctor by Robert Wachter, MD, is the book that will have the most long-lasting impact on health IT, and perhaps all of healthcare. Here are five takeaways.
Last winter, two health IT books dominated the discourse: Where Does It Hurt? An Entrepreneur's Guide to Fixing Health Care by athenahealth CEO and cofounder Jonathan Bush; and The Patient Will See You Now: The Future of Medicine is in Your Hands by Eric Topol, MD, cardiologist and chief academic officer of Scripps Health.
But the 2015 book that will have the most long-lasting impact on health IT, and perhaps all of healthcare, has to be The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine's Computer Age by Robert Wachter, MD, who directs the 60-physician division of hospital medicine at the University of California, San Francisco.
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Health IT interoperability by example
Posted on Aug 31, 2015
By John W. Loonsk, MD, CGI
ONC has a ten year roadmap to its achievement…but a recent survey says providers don't believe that even ten years will be enough if we stay on the current course. Congress is threatening legislation about EHR "data blocking"…but it is not clear that data blocking is a real obstacle to interoperability. Some are saying that "the industry" should now lead... but there were many unsuccessful years of that. The federal health IT advisory committees are convening yet again to ask what it will take to get to interoperability… but there is no reason to think that the outcome will be different this time. The "once-in-a-lifetime" HITECH incentive program is all but finished…but now, the National Coordinator, Karen DeSalvo, has said that more should have been done to advance interoperability from the start.
And yet, with all the confusion and the limited progress of general health IT interoperability, electronic prescribing (eRx) has moved smartly from concept to operations over a similar time period. There are certainly differences and caveats related to using eRx as an example for the broader activity. And many prescriptions are still not executed electronically – but interoperability is not the reason. And there are some clear lessons to learn here.
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How one health system tightened security
Posted on Aug 31, 2015
By Bernie Monegain, Editor-at-Large
St. Elizabeth Healthcare in Northern Kentucky has added security muscle targeted at its network-connected medical devices by rolling out technology that monitors the devices for cyber vulnerabilities.
The health system tapped Tenable Network Security for nonstop network monitoring via the company's SecurityCenter Continuous View, which makes it possible to keep watch over the devices without taking them offline.
Through this deployment, hospital executives say, St. Elizabeth's IT security team has tackled one of the biggest security challenges in the healthcare industry – securing "smart" medical devices that cannot be interrupted for active vulnerability assessments.
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Rule change enables e-prescribing of all controlled substances nationwide
August 31, 2015 | By Dan Bowman
All controlled substances now legally can be electronically prescribed in any state, nationwide, after Vermont enacted updated administrative rules on Aug. 28.
While Missouri, in late July, became the last state to pass laws allowing the e-prescribing of controlled substances, according to its state medical association, Vermont, which had already allowed some e-prescribing, limited those efforts to Schedule 3-5 drugs. The Green Mountain State, last Friday, changed its rule to include Schedule 2 controlled substances, such as hydrocodone and morphine.
According to Surescripts CEO Tom Skelton, "throwing out the prescription pad" in lieu of electronic prescribing will help to curb potential fraud and drug abuse.
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Health IT tools lack proof of effectiveness
August 31, 2015 | By Katie Dvorak
There are myriad apps, tools and technologies entering the healthcare marketplace--but most lack proof that they are helping consumers battle disease and stay healthy, according to an article in Fortune. To that end, hospitals must be very careful when adopting health IT, according to Richard Milani, chief clinical transformation officer at Ochsner Health System.
"You want to be comfortable that the technology you're utilizing is reliable and accurate," Milani tells Fortune. "That's a genuine concern. If you have some scientific data or peer-reviewed data to back it up, that certainly makes it a little easier."
Outside the hospital, the potential of too many apps invading the marketplace, with many going unvetted, also is a concern that demands attention, according to an article published at the Journal of the American Medical Association.
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Alphabet Breathes New Life, Resources Into Google's Health Care Projects
Monday, August 31, 2015
Earlier this month, Google executives rocked the Internet with the announcement of Alphabet -- a new portfolio-like company that will separate Google's core business -- such as search, Gmail, YouTube and maps -- from projects, such as those in health care, that are farther afield.
Some industry observers note that investors had growing concerns about Google's broadening business ventures, which range from its foundation as an Internet search company to less lucrative projects, such as drones, pharmaceuticals and venture capital. Some analysts say the move could help ease some of those concerns by allowing investors to see the real value of Google, which will release separate quarterly financial results from Alphabet.
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Enjoy!
David.
