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."

Saturday, April 05, 2014

Weekly Overseas Health IT Links - 5th April, 2014.

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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Latest ICD-10 one-liner is no joke

Posted on Mar 28, 2014
By Tom Sullivan, Editor, Government Health IT
ICD-10 has been the butt of countless jokes during the last several months but none so surprising as the latest one-liner. Only this isn’t funny.
Whether you’re on that chair edge hoping President Obama gets a chance to sign the provision pushing ICD-10 back within the Sustainable Growth Rate fix into law, or crossing fingers that the Senate kills it come Monday, no matter.
The reality is that a code set conversion simply should not be about politics.
Other than lazily dumping ICD-10 and the SGR process for determining how much to pay doctors who treat Medicare patients under the umbrella term of healthcare reimbursements, the tie between them prior to the now infamous Section 212 bomb within the bill, ICD-10 and SGR have almost nothing to do with each other.
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Data-sharing cuts unnecessary ER visits by 10 percent

March 28, 2014 | By Susan D. Hall
A data-sharing initiative among emergency departments in Washington reduced ER visits by Medicaid patients by 10 percent in the program's first year, according to a report from the Washington State Health Care Authority.
It hasn't been a completely voluntary effort, reports Bloomberg Businessweek. After attemts to cap reimbursement for non-emergency visits to ERs led to outcries from providers, the state, hospitals, and physicians came together to create what they call their "Seven Best Practices"mainly that doctors need more information in the ER and afterward to provide the most effective care in the least-costly setting.
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HHS unveils security risk assessment tool

March 28, 2014 | By Ashley Gold
A new security risk assessment (SRA) tool aimed to help healthcare providers in small to medium sized offices conduct risk assessments of their organizations is now available from the U.S. Department of Health & Human Services. The tool was first mentioned at a session during HIMSS14 in February.
"Protecting patients' protected health information is important to all health care providers and the new tool we are releasing today will help them assess the security of their organizations," National Coordinator for Health IT Karen DeSalvo said in announcement. "The SRA tool and its additional resources have been designed to help health care providers conduct a risk assessment to support better security for patient health data."
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Increased Use of Health IT Equates to Less Face-Time with Patients, Says Report

Written by Ayla Ellison (Twitter | Google+)  | March 27, 2014
A new trend report has confirmed increased use of health IT by healthcare providers results in a decrease in face-to-face interactions with patients.
The newly released report is part of an ongoing series that analyzes the results of the third bi-annual Health IT Survey. The survey was conducted in 2008, 2010 and 2012 to identify primary trends in health IT systems as well as current and emerging software applications.
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Agencies See Big Data As Cure For Healthcare Ills

3/26/2014 12:25 PM
Federal healthcare agencies believe big data will improve the nation's health -- but few are prepared to use it, a study finds.
Two-thirds of federal executives working in healthcare-focused agencies believe that big data will improve population health management and preventive care. But even though feds report in a new study that they must tap into emerging technologies such as wireless health devices and machine-to-machine monitoring systems, only a small percentage of government agencies have implemented them.
According to the findings, 63% of federal IT professionals feel that big data will help track and manage population health more efficiently, 62% view big data as a way to significantly improve patient care within military health and Veterans Affairs (VA) systems, and 60% believe big data will improve how preventive care is delivered.
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eHealth Initiative to lay out healthcare roadmap for 2020

March 27, 2014 | By Susan D. Hall
The eHealth Initiative has set out to create a vision for healthcare through the end of the decade through a public-private collaborative effort called the eHealth Initiative 2020 Roadmap.
Though meetings with a wide range of stakeholders, it plans to make key policy recommendations to implement at a federal level and propose actions for the private sector to spearhead to transform care delivery through data exchange and health information technology (IT), according to an announcement.
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IT leaders stressed about project money

Posted on Mar 27, 2014
By Bernie Monegain, Editor
Not having enough money to complete a successful IT implementation is the top worry of participants in the 25th Annual 2014 HIMSS Leadership Survey. The survey examines a wide array of topics crucial to healthcare leaders including IT priorities, issues driving and challenging technology adoption and IT security.
While a majority of the survey participants -- 65 percent -- reported IT budget increases, which is likely a contributing factor to the transition to a paperless environment, HIMSS officials noted in a news release, a lack of adequate financial resources now tops the list of barriers to successful IT implementation. This is a shift from the past two years when the primary IT challenge was insufficient and untrained staffing resources.
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Unlocking the Power of Health Data

by David Harlow Thursday, March 27, 2014
In this day and age, with fewer and fewer exceptions, each of us has a digital footprint as a patient. Each of us has an intentional digital footprint, created by each of us directly and by the trusted others with whom we interact in the real world and online -- through electronic health records, personal health records, personal tracker data, blogs, tweets, etc.
Each of us also has a trail of additional information that is a by-product of our online existence, our digital exhaust, which is out there to be mined for data. All of these data sources -- individually or, more likely, when aggregated with that of others -- may turn out to be usable as information, or perhaps even knowledge.
That is the promise of EHRs, and one key policy argument behind the federal government incentive program promoting their adoption: that health data writ large -- big data -- when properly analyzed will yield medical insights not otherwise accessible to us; that evidence-based medicine will be advanced immeasurably and that the dissemination of best practices will be tremendously accelerated.
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Growing Beyond Yesterday's Population Health Management

3/26/2014 09:06 AM
Data can transform healthcare, but not with just any ordinary analytics.
Analytics -- the mathematical savior of oh-so-many population health management (PHM) programs -- is all the rage in health IT marketing circles these days. As the electronic medical records gold rush slowly ebbs over the next few years, attention is gradually shifting to approaches we can use to fundamentally change the cost and quality of care... and what we should do with all this data.
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HHS Health Information Exchange Strategy Lacking, Says GAO

MAR 25, 2014
Health information exchange technology has the potential to bring patient information directly from an electronic health record to a provider delivering care.
However, a new Government Accountability Office report has found that providers and stakeholders in four states are facing several challenges with ongoing electronic health information exchange efforts. Barriers include insufficient standards, concerns about varying privacy rules among states, difficulties in matching patients to their records, and costs.
The problem, GAO says, is that the Department of Health and Human Services and its various units lack specific prioritized actions and milestones to address obstacles to successful information exchange. In particular, several providers told GAO that they have difficulty exchanging certain types of health information due to insufficient health data standards. 
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AHIMA Warns About Use of EHR Copy and Paste Practices

MAR 26, 2014
The American Health Information Management Association has issued a position statement warning industry stakeholders about the risky practice of copy and pasting within an electronic health record.
"Use of the copy and paste functionality in EHRs can result in redundant, erroneous, and/or incomprehensible health record documentation," states the document. "Misuse of this functionality has the potential to result in or contribute to several overarching challenges, with implications for the quality and safety of patient care, medical-legal integrity of the health record, and fraud and abuse allegations."
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Virtual doctor visits take off at Kaiser

Posted on Mar 24, 2014
By Jeff Rowe, Contributing Writer
In 2013, Kaiser Permanente conducted 10.5 million patient-doctor visits via e-mail, telephone or video tools, and in a new report the organization discusses some of the ways those visits took place.
For example, a secure e-mail service allows users to attach images (such as a digital picture of a rash, for instance) in a message to a Kaiser dermatologist. In 80 percent of those cases, the dermatologist was able to offer a definitive diagnosis and prescribe without an office visit.
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Blowing in

The government is confident that cloud-based services are the future of IT in the public sector; and many suppliers agree with it. The NHS is not convinced, although primary and community services are starting to put a finger in the wind. Fiona Barr reports.
Two years ago, the head of the government’s G-Cloud programme predicted that cloud computing would cut government IT costs by up to 75%.
For a cash-strapped NHS that probably sounded like an appealing hypothesis; although it is one many healthcare organisations have seemed reluctant to put to the test.
Security concerns
The reasons for that reluctance are likely to be multi-faceted. One obvious barrier to adoption is a lack of confidence about the security of identifiable patient data held in the cloud.
Organisations are nervous about losing control of their data, in much the same way that many were concerned about moving from organisation-based to hosted solutions a decade ago.
In primary care, most GP practices had servers in their practices ten years ago, but since then hosted solutions have become the norm - and the cloud is now taking over.
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Study: Bedside sensor reduces length of stay in hospital and ICU

Laura Pedulli
Mar 24, 2014
A sensor placed under a hospital bed that continuously monitors a patient’s heart, respiratory rate and movement was shown to significantly reduce patients’ total length of stay in a hospital and intensive care unit (ICU).
Harvard University Medical School researchers conducted a controlled 7,643 patient outcome study of EarlySense’s monitoring system, in which they compared a 33-bed medical-surgical unit (intervention unit) to a sister control unit for a 9-month pre-implementation and a 9-month post implementation period.
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Mobile health market projected to surge

By AuntMinnie.com staff writers

March 25, 2014 -- The market for global mobile health (mHealth) technologies is expected to grow at a five-year compound annual growth rate (CAGR) of 55% to reach $21.5 billion in revenues by 2018.
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More Medical Interoperability Could Lead to Big Savings

March 25, 2014
Medical interoperability could be a source of more than $30 billion a year in savings and improve patient care and safety, according to a new white paper released by the La Jolla, Calif.-based Gary and Mary West Health Institute and the Office of the National Coordinator for Health Information Technology (ONC).
The white paper, summarizing the HCI-DC 2014: Igniting an Interoperable Healthcare System conference, features lessons learned and synthesizing findings into a call for action to achieve an interoperable healthcare system. The West Health Institute’s HCI-DC 2014, which took place Feb. 6, 2014 in Washington D.C., and was co-hosted by ONC, brought together experts from across the healthcare community to consider how interoperability can cut costs, improve efficiency, reduce errors, and improve health .
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HHS lays out 4-part health IT strategic plan

By Diana Manos, Senior Editor
The Department of Health and Human Services has named health information technology as key to the “modernization of the American health care system” in its latest strategic plan.
The plan has four major goals, which include:
  1. Strengthen health care
  2. Advance scientific knowledge and innovation
  3. Advance the health, safety, and well-being of the American people
  4. Ensure efficiency, transparency, accountability, and effectiveness of HHS programs
And to that end, the Office of the National Coordinator for Health Information Technology plays a big part, according to HHS. ONC "pursues the modernization of the American health care system through a collaborative framework that addresses critical health information technology (IT) challenges by supporting the adoption of common policies and standards that support the meaningful use of health IT,” the plan says.
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4 ways to high performing supply chain

Posted on Mar 25, 2014
By Todd Ebert, Contributing Writer
The supply chain represents about 25 percent of a healthcare facility’s operating budget, and industry trends strongly indicate that this percentage will continue to grow. Thus, supply chain optimization is not an option, it's a must.
Here are some solid best practices that can help your facility build a “new” supply chain focused on efficient processes and maximized outcomes.
Obtain senior management commitment
Continual commitment from senior management helps keep projects moving and demonstrates their importance to all hospital staff. Even if the project originates in materials management, the materials manager should win executive team support before engaging physicians and surgeons. Senior leadership must be willing to support the process, stay with it through difficult moments and see it through on an ongoing basis.
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Health IT leaders must 'adapt or die'

March 25, 2014 | By Ashley Gold
Healthcare organizations struggling with information technology must "adapt or die," according to a recent article in CIO magazine.
Thanks to electronic health records, patient data is now in repositories, and CIOs must make sense of all that data and protect it.
Skip Snow, a senior analyst with Forrester research and advisory firm, told CIO about five technology imperatives for U.S. healthcare providers--here are three:
  1. Clean up data: Snow says organizations must at least be able to import and export HL7 continuity of care (CCD) files; they also should consider creating an infrastructure that safeguards protected health information (PHI).
  2. Invest in customer and patient insight: This means investing in clinical, operational and financial data management tools and establishing a common vocabulary for shared business entities.
  3. Embrace mobile: mHealth, among many other uses, can be used as a bridge between remote monitoring and EHR systems, easing patient concerns about telehealth.
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Kaiser informatics director: IT must be about continuous quality improvement for nurses

March 25, 2014 | By Dan Bowman
No one IT system is perfect for improving care, according to Ann O'Brien, RN, director of clinical informatics at Oakland, Calif.-based Kaiser Permanente. Rather, she said, continuous performance improvement should be the primary goal of technology use in healthcare.
"You have to look at what can enable small amounts of change" as it relates to a larger goal of better quality for patients, O'Brien (pictured) said, speaking last Friday at an IT summit for nurses held by the Office of the National Coordinator for Health IT, the American Nursing Informatics Association and the American Nurses Association at Baltimore Washington Medical Center in Glen Burnie, Md.
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Hot stuff

An electronic check list to help GPs identify patients at risk of stroke and get them the right treatment was a winner at the EHI Awards in 2013. Fiona Barr reports.
25 March 2014
A simple IT solution that enables the delivery of gold standard care for patients time after time is the Holy Grail for those working with NHS technology.
One such solution, an electronic checklist for patients who have suffered a transient ischaemic attack (TIA), has been developed in Essex; and scooped  the award for ‘clinical treatment and care’ at the EHI Awards 2013 in association with CGI.
The hyper-acute online TIA (HOT-TIA) referral form automatically calculates a patient’s risk of stroke for GPs, creating a red alert for immediate admission if the patient is at high risk and enabling those at low risk to be seen within seven days.  
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Interoperability Needs More Than Fired-Up Buyers

Scott Mace, for HealthLeaders Media , March 25, 2014

Health information technology buyers have been demanding interoperability for some time, yet too many IT vendors have too often kept the door to interoperability locked tight, denying the industry $30 billion in potential savings.

On his first comedy album, Bill Cosby did a timeless bit called The Pep Talk where a football coach gets his team all fired up in the locker room before game time and then sends them forth… only to be stopped by a locked door.
This bit came to mind as I read a new report from the Gary and Mary West Health Institute, which along with the Office of the National Coordinator for Health Information Technology, held a one-day conference on healthcare IT interoperability last month.
In the report, the authors urge all buyers of healthcare IT, that's healthcare systems, hospitals, practices and patients, to insist that technology vendors make their products work well with each other, share data, and support open standards.
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The Use and Misuse of Information Technology in Health Care: Several Doctors Reply

One of them writes, "There is a very American tendency to look for technological fixes for significant problems.  In general, technological fixes only work in the context of appropriate institutional structures."
James Fallows Mar 24 2014, 5:00 AM ET
Our new issue has an interview with Dr. David Blumenthal about why it has taken the medical system so long to adopt electronic record-keeping, and what it will mean when the switch occurs. (Blumenthal led the Obama administration's effort to encourage that change.) On Friday several technology experts and doctors weighed in with responses. Here are a few more.
1) "Give us a cotton gin." Creed Wait, a family-practice doctor in Nebraska does not like the mandated shift to electronic records, at all. [I've added his name, as he sent permission to use it. Also he has moved from Texas to Nebraska.] For now, I am sharing his detailed complaint in full, rather than interspersing comments or "Yes, but" queries:
The saying is, “Build a better mousetrap and the world will beat a path to your door. “
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Tripathi: Health IT and HIE Starting to ‘Take Off’

MAR 21, 2014
The changing market climate has improved incentives for the adoption of healthcare information technology and health information exchange and as a result HIT and HIE are “beginning to take off,” according to Micky Tripathi, president and chief executive officer of the Massachusetts eHealth Collaborative.
“Up until five years ago, the healthcare system had notably underinvested in electronic health records and health information exchange compared both to other sectors in the economy and other industrialized countries,” said Tripathi. “But, we’ve made a tremendous amount of progress based on the Meaningful Use program over the last few years.”
Tripathi, who gave the industry perspective March 20 at a Federal Trade Commission workshop in Washington, argued that Meaningful Use Stage 1 has been “an enormous success” and “now what we are seeing is a lot of tension in what’s the appropriate role of government” in Stage 2 and Stage 3.
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Arizona to study best practices for patient matching

March 24, 2014 | By Susan D. Hall
Arizona plans to explore best practices and alternative approaches to correctly match patients to all of their available records across multiple organizations.
The effort is part of the Health IT Roadmap 2.0 from the state's Strategic Enterprise Technology Office, which describes 19 key initiatives to advance health information technology and health information in Arizona.
"It is a controversial issue," Arizona Health-e Connection CEO Melissa Kotrys told Healthcare Informatics, "but when we convened stakeholders to talk about key issues, this topic of the difficulty of patient identification came up, even with master patient index solutions. So there was enough interest to explore this topic further."
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How nurses can maximize technology use for better patient care

March 24, 2014 | By Dan Bowman
Nurses looking to get the most out of healthcare IT for their patients would be wise to adopt such tools in their own everyday lives, according to Patricia Sengstack, Chief Nursing Informatics Officer at Bon Secours Health System, a Baltimore-based system with 18 acute-care hospitals that spans seven states.
Speaking last week at an IT summit for nurses held by the Office of the National Coordinator for Health IT, the American Nursing Informatics Association and the American Nurses Association, Sengstack (pictured)--who also serves as ANIA president--outlined several tips for nurses who want to embrace their role in health IT.
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Med device recalls double

March 24, 2014 | By Susan D. Hall
Recalls of medical devices have doubled in the past decade--the number of recalls grew from 604 in 2003 to 1,190 in 2012, an increase of 97 percent, according to recent a U.S. Food and Drug Administration report.
The rate actually lags the rate of growth in the med tech market overall, as FierceMedicalDevices points out.
Class I recalls-the FDA's most serious category, reserved for potentially deadly defects--rose from seven in 2003 to 57 in 2012.
Meanwhile, U.S. medical device expenditures climbed from $73.7 billion in 2001 to $156.3 billion in 2010--an 112 percent increase. What's more, the number of medical devices on the market grew by 25 percent from 2008 through 2012 alone.
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ONC corrects 2015 Edition proposed rule

Beth Walsh
Mar 23, 2014
The Office of the National Coordinator for Health IT (ONC) has made corrections regarding four certification criteria to its proposed rule for the voluntary 2015 Edition of EHR technology certification criteria.
ONC's Federal Policy Division Director Steven Posnack corrected the preamble text and gap certification table for the certification criteria that were omitted and provides information on inactive web links that appear in the proposed rule. "These errors are identified and corrected in this correction notice," Posnack wrote.
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Telehealth Gets New Momentum, Allies

by Rebecca Vesely, iHealthBeat Contributing Reporter Monday, March 24, 2014
Health reform and improved technology are driving interest in telehealth adoption among providers and patients -- and policymakers are starting to get the memo.
It's a marked change since just a year ago, when policy momentum around the issue was somewhat stalled. Last March, just 13 states had legislation pending on telehealth. Today, 34 states and the District of Columbia have active telehealth legislation, with 44 statehouse bills addressing improved reimbursement for telehealth services, according to new data from the Center for Connected Health Policy in Sacramento, Calif.
"People are starting to recognize that telehealth has value in the context of health reform and the steep demands placed on providers to meet issues around timely access, especially to specialists," said Mario Guttierez, executive director of the CCHP, which is partially funded by the California HealthCare Foundation. CHCF publishes iHealthBeat.
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Brussels, 24 March 2014

eHealth in the EU: what's the diagnosis?

"Europe is facing a healthcare crunch as a result of our ageing population. By making the most use of digital tech, we can reduce costs, put the patient back in control, make healthcare more efficient and help European citizens to take an active part in society for longer. We have to keep our finger on the pulse!"– Neelie Kroes
What's the diagnosis?
According to two surveys in acute care hospitals (those intended for short-term medical or surgical treatment and care) and among General Practitioners (GPs) in Europe, the use of eHealth is starting to take off, with 60% of GPs using eHealth tools in 2013, up 50% since 2007. But much more needs to be done.
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'Wouldn't It Be Amazing If Everyone's Medical Records Were Available Anonymously To Research Doctors?'

Dylan Love Mar 23, 2014, 2:39 AM
Speaking at the 30th anniversary TED event in Vancouver earlier this week, Google co-founder and CEO Larry Page hypothesized a system that would make people’s medical records available anonymously to research doctors for the sake of having access to a wide pool of medical information.
He also used the idea to make a compelling point about how and why we share data online.
“Wouldn’t it be amazing if everyone’s medical records were available anonymously to research doctors?” Page said. “When someone accesses your record — a doctor — you could see which doctor accessed it and why. You could maybe learn about what conditions you have. I think if we just did that, we could save 100,000 lives this year.”
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Enjoy!
David.

Friday, April 04, 2014

The RAND Corporation Reviews Health IT Studies For ONC. A Very Important Study Indeed.

This appeared during the last few weeks.
Health IT Literature Review Report and Interactive Data Visualization on the Health IT Dashboard!
ONC recently updated its Health IT Dashboard with the results of a comprehensive literature of the impacts of health IT titled: Health Information Technology: An Updated Systematic Review with a Focus on Meaningful Use Functionalities. The literature review updates previous systematic reviews with the new peer review literature published during the 2010 to 2013 time frame.
The literature review results include findings that the majority of new studies indicate that health IT enabled significant gains in health care quality, but efficiency and safety were still the subjects of relatively little research. In addition, this report has a complementary interactive data visualization that allows users to see the value of health IT across these outcomes. The report and data visualization are just one of many examples of what ONC has been doing to show the value of health IT and make data come alive.
Download the full report [PDF — 2.2 MB] from HealthIT.gov, or dig deeper into the literature with ONC's interactive data visualization. With the data visualization you can:
  • Read about the effect of health IT on outcomes
  • Use a clickable interactive tree map that shows what Meaningful Use health IT functionalities have positive or negative impacts on healthcare outcomes.
  • Browse through a sortable and interactive table of 236 new health IT studies to explore what the new research evidence shows regarding the relationship between health IT and quality, safety, and efficiency.
There is a fair bit of commentary on this report.
See here

Health IT benefits outweigh the negative, report shows

By Erin McCann, Contributing Editor
A new study conducted by RAND Corporation for the Office of the National Coordinator for Health IT has found that the benefits of health IT outweigh any negative or neutral effects of their use.
The January study examined 236 health IT studies from 2010 to 2013. It found that 77 percent of them reported either positive or mixed-positive outcomes -- meaning there existed at least one negative association between health IT and the care metric, but the original authors concluded the benefits outweighed negative or neutral effects.
However, nearly 20 percent of the studies on health IT's efficiency outcomes yielded negative results, and only 45 percent saw overwhelmingly positive outcomes. Researchers described efficiency as including costs, utilization and timelines.
Drilling down further into efficiency, CDS alerts and reminders were proven to be most ineffective, with some 43 percent having reported negative results.
"Cost effects ranged from a 75 percent decrease to a 69 percent increase in the targeted costs; however, many of the studies clustered in the range of six percent to 12 percent increases in the targeted costs," RAND officials wrote in the report. "These findings suggest that layering technology on the existing payment system may not result in lower costs."
As for patient safety, researchers also found mixed results. For instance, 17 percent of the studies assessing health IT's impact on safety had produced negative outcomes, and 67 percent had reported all positive results.
"While the great majority of studies reported positive outcomes for process quality measures, not all studies did so, and most studies lacked sufficient detail to determine which factors may have led to the lack of benefit found," officials wrote.
The report underscored quality as the metric most improved by implementing health information technology, as the lion's share of studies, 58 percent, saw positive outcomes, and another 24 percent saw mixed-positive results.
When officials drilled down further into the data, they also found clinical decision support, computerized provider order entry and meaningful use all produced the most beneficial outcomes, at 66 percent, 64 percent and 63 percent positive respectively.
Contrastingly, electronic prescribing was the least able to prove its worth, as more than one-fourth of all studies reported negative outcomes.
Lots more here:
And here:

ONC publishes new review of health IT functionalities

March 5, 2014 | By Marla Durben Hirsch
More than three-fourths of studies on health IT have found that technology provides at least some positive impact on patient care, but the studies themselves need improvement, according to the Office of the National Coordinator for Health IT's new literature review, prepared by the RAND Corporation.
The 145-page report updates previous reviews on the effects of health IT on patient care. This is the first review to focus specifically on identifying and summarizing the evidence relating to the use of health IT outlined in the Meaningful Use regulations.
The review of literature, from January 2010 to August 2013, found that 77 percent of the studies meeting the eligibility criteria reported positive or mixed positive results; studies on safety and quality reported more positive results than those on electronic health record efficiencies.  The researchers also found that the effect of health IT was influenced by the particulars of the IT system used, the implementation process and the context in which the IT was implemented.
More here:
This is clearly the best aggregated research on health IT. Download the .pdf and have a read!
David.

Thursday, April 03, 2014

Here Is How The USA Manages The Issue Of Software Errors In Clinical Software. Interesting.

These reports appeared a few days ago:

FDA issues recall of McKesson Anesthesia Care Record

Author Name Kyle Murphy, PhD   |   Date March 20, 2014   |  
Nearly a year after McKesson notified its customers about flaw in one of its health IT systems, the Food and Drug Administration (FDA) has moved to applying a Class I recall. The product in question is McKesson’s Anesthesia Care Record (ACR), a clinical decision support system aimed at helping anesthesiologists identify potential adverse drug events.
“The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care,” the FDA notes.
According to the FDA notice, McKesson began alerting ACR users of a danger posed by the system on March 15, 2013. “There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. Use of this affected product may cause serious adverse health consequences, including death,” the recall states.
The recall notice makes clear that McKesson actively engaged via a series of phone calls, written statements, and a “Clinical Alert” as well as verified that customers “read and understood the issue and preventive action to take.” Voluntarily McKesson filed a Class II recall near the end of March 2013.
Apparently, those efforts weren’t enough to dissuade the FDA from slapping the Class I recall tag on McKesson’s ACR product, a designation applying to “situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” It is the highest level of all recalls.
More here:
Here is the second one:

FDA Again Issues Recall Notice for McKesson Anesthesia Care Software

MAR 19, 2014
The Food and Drug Administration on March 14 issued a Class 1 recall notice to healthcare professionals for the Anesthesia Care software of McKesson Corp. The software collects, processes, and records data both through manual entry and from monitors which are attached to patients, such as in an operating room environment. San Francisco-based McKesson had initiated a voluntary Class II recall of the product last year.
The Class I recall is in the FDA’s highest risk category which is reserved for defects where “there is a reasonable probability that the use of or exposure” to the product “will cause serious adverse health consequences or death.” It is not often that the regulatory agency issues this kind of recall notice for standalone software that does not play a role in operating a medical device. However, the software “provides clinical decision support by communicating potential adverse drug event alerts proactively during the pre-anesthesia evaluation and at the point-of-care,” the FDA said in the notice.
“There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record in that it included data from another case,” states the FDA notice. “Use of this affected product may cause serious adverse health consequences, including death.”
Lots more here:
What interested me were two things. The big one is that clinical software can be monitored and tracked for issues and if problems arise there are substantial powers to have the issues remedied. Having such protections which are actively enforced can only be a good thing.
My other point is that action seemed to be taken rather slowly - not sure why. I wonder how our TGA would handle all this?
In passing I note medical device safety is also being carefully monitored.

FDA Surveillance System Leverages Databases to Monitor Medical Products for Adverse Events

MAR 19, 2014
The Food and Drug Administration is actively searching more than 100 million health insurance records to uncover possible adverse events, rather than relying on doctors and patients to report them, according to Michael Nguyen, M.D., Acting Director of the Division of Epidemiology in FDA’s Center for Biologics Evaluation and Research.
The surveillance system, called Sentinel, is the result of a partnership between FDA and the Harvard Pilgrim Healthcare Institute, who are using the system to determine whether a certain type of immune therapy is associated with heart attacks or strokes, and to better define the true rate of acute lung injury after transfusions of certain blood components. 
Lots more here:
David.

Wednesday, April 02, 2014

Pre - Budget Review Of The Health Sector - 3rd April 2014.

As we head towards the Budget in Early to Mid-May 2014 I thought It would be useful to keep a closer eye than usual on what was being said regarding what we might see coming out of the Budget.
According to the Australian Parliament web site Budget Night will be on Tuesday 13th May, 2014.
Here are some of the more interesting articles I have spotted this week.
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Surgical blowout if funds savaged

  • March 30, 2014 12:00AM
DOCTORS have warned elective surgery and emergency department waiting times will be hit by a $560 million federal funding cut to hospitals.
NSW hospitals stand to lose $200 million over four years under the current agreement.
The federal government has blamed the previous Gillard government for the cuts.
A new analysis of figures in Treasurer Joe Hockey’s midyear fiscal update reveal the national health reform funding for hospitals will strip $560 million from frontline health services by 2017.
Australian Medical Association president Steve Hambleton said if there was less money in the system, frontline services would suffer.
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Australian Private Hospitals Association 33rd National Congress Keynote Address

The Minister for Health Peter Dutton delivered the keynote address at the Australian Private Hospitals Association National Congress in Brisbane on 24 March 2014.
Page last updated: 24 March 2014
24 March 2014
Ladies and Gentleman, good morning and thank you for the introduction.
Thank you very much to Chris Rex for your words earlier and thank you Michael Roff also. We have developed, I think, over the years an excellent working relationship and I look forward very much to that continuing.
Thank you for meeting in my home town of Brisbane.
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Interview on Sky News with Peter Van Onselen

Minister for Health Peter Dutton was interviewed on Sky News with Peter Van Onselen and spoke about Knights-Dames, Racial Discrimination Act, Medibank Private Sale and Health Reform.
Page last updated: 26 March 2014
26 March 2014
Topics: Knights-Dames, Racial Discrimination Act, Medibank Private Sale, Health reform.
Peter Van Onselen: The Government moved today to sell Medibank Private. We knew that it was going to be happening, but it has now been announced, it will happen after legislation was first passed to allow the sale back in 2006.
We’re going to be taking a bit of a look through, not just the issue of Medibank Private and its sale, with Peter Dutton; but I started by asking what he thought about the whole Knights and Dames issue, you’ll be surprised to know. Take a look.
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Battlers exposed again as budget crunch nears

Date March 29, 2014

Ross Gittins

The Sydney Morning Herald's Economics Editor

With the Abbott government's close relations with big business, we're still to see whether its reign will be one of greater or less rent-seeking by particular industries. So far we have evidence going both ways.
We've seen knockbacks for car makers, fruit canners and Qantas, but wins for farmers opposing the foreign takeover of GrainCorp and seeking more drought help, as well as a stay on the banks' attempt to water down consumer protection on financial advice.
The next test will be the budget. Will the end of the Age of Entitlement apply just to welfare recipients (especially the politically weak, e.g. the unemployed and sole parents, rather than politically powerful age pensioners) or will it extend to ''business welfare''?
With Joe Hockey searching for all the budget savings he can find, there's a lot of business welfare or, euphemistically, ''industry assistance'' to look at. The Productivity Commission measures it every year in its Trade and Assistance Review.
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Risks outweigh Medibank float's meagre reward

Date March 29, 2014

Michael West

Business columnist

Dear knights, dames and peasants, far be it for this lowly quill-driver to launch inquiry upon the pronouncements of Her Majesty's most loyal subject, Sir Tony of the Order of The Red Speedo.
Upon our oath, only knaves and sodden-witted loons would quibble that Sir Tony's decree to restore knighthoods and damehoods was inspired. Why, 'tis no giant's leap even for Edward Obeid to upgrade from his present order of chivalry.
In truth we speak! Yea, a Medal of the Order of Australia was bestowed upon noble Edward by Her Royal Highness in 1984.
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Insurers shouldn't pay GP gap fees: Dutton

26 March, 2014 Paul Smith
Any funding of GP services by private insurers should not be focused on paying doctors’ gap fees, the Federal Health Minister has warned.
In a key speech to industry heavyweights this week, Peter Dutton (pictured) said he was happy for insurers to give "additional support" to doctors, saying it has the potential to support Medicare rather than undermine it.
"[If] insurers are prepared to work collaboratively with doctors and patients then we should welcome that development," he told the Australian Private Hospitals Association congress in Brisbane on Tuesday.
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Private insurers should have a role in primary care: Dutton

27 March, 2014 Nicola Garrett
It’s time to shake off the shackles of history and embrace private health involvement in primary care, Federal Health Minister Peter Dutton has said in a speech to business leaders this week. 
“They have been excluded from the primary care space for historical reasons and if insurers are prepared to work collaboratively with doctors and patients then we should welcome that development”, Dutton said in an opening address to the Australian Private Hospitals Association’s National Congress in Brisbane this week. 
Dutton said his main goal was to provide more support at a primary care level that was in the patients best interest and ultimately that of the Australian taxpayer.
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Dutton, industry can health premium fear

THE sale of Medibank Private is unlikely to put pressure on premiums, but will raise industry hopes of reforms to ensure policyholders get value for money.
Industry sources yesterday shared the federal government's confidence the sale would not adversely affect premiums, given that Medibank Private operates as a for-profit insurer and the market is diverse.
Health Minister Peter Dutton has vowed to "continue to keep downward pressure on prices" and ensure that coverage, which currently takes in 47 per cent of the population, remains high. "Nobody's been able to mount the argument that the sale of Medibank Private, in a mature marketplace with 30-odd providers of health insurance, would dampen competition or provide anything by way of upward pressure on premiums," Mr Dutton told Sky News.
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Doctors' contracts row: Health Minister Lawrence Springborg says deadline extension not possible

March 27, 2014

Queensland Health Minister Lawrence Springborg has ruled out extending the deadline for senior doctors to sign controversial new contracts.
The Australian Medical Association (AMA) has called for extra time in a bid to negotiate and prevent mass resignations.
It says junior doctors are now getting involved in the dispute amid fears they will lose support if senior medical officers follow through on threats to resign en masse over the agreements.
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Rich suburbs have low immunisation rates, research shows Date

March 27, 2014

Lucy Carroll

Health Reporter

Affluent suburbs in Sydney's north, inner west and east have some of the lowest childhood immunisation rates in Australia, new research shows.
Doctors say they are struggling to fight misinformation from anti-vaccine groups and fear outbreaks of measles and other infectious diseases that could have devastating effects. And many parents who are simply ''not getting around'' to vaccinating their children are making the problem worse.
Only about 80 per cent of five-year-old children in suburbs such as Manly, Paddington and Annandale are fully immunised against contagious diseases, compared to significantly higher rates in the Illawarra area, data from the National Health Performance Authority shows.
Experts say parents in inner-Sydney could be failing to complete their children's vaccinations because they travel or move overseas, are concerned about side effects or are influenced by ''misleading information'' from the anti-vaccination lobby.
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Out-of-pocket healthcare costs inquiry expected

26th Mar 2014
AN INQUIRY into out-of-pocket healthcare costs is expected to get the green light in the Senate on Wednesday amid speculation about the government’s plans for Medicare.
The motion, led by Greens Senator Dr Richard Di Natale, calls for an inquiry to examine the impact of co-payments on consumers' ability to access healthcare, and related healthcare outcomes and costs.
It will also seek to investigate the role of private health insurers, the likely effects of co-payments on other parts of the health system as well as the “appropriateness and effectiveness of safety nets and other offsets”.
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Senate inquiry to investigate high out-of-pocket health costs

Date March 25, 2014 - 12:47PM

Dan Harrison

Health and Indigenous Affairs Correspondent

Labor will team up with the Greens to force a Senate inquiry on the health costs incurred by patients, as the Abbott government considers introducing a fee to visit the doctor.
Greens senator Richard di Natale will give notice on Tuesday that he will move for a wide-ranging inquiry that will look a trends in out-of-pocket health costs, the role of private health insurance and the effect of co-payments on health outcomes.
A vote will be held on the motion on Wednesday. It is likely to pass with the support of Labor.
An analysis in January by the health research organisation Commonwealth Fund found out-of-pocket costs for Australian patients were higher than all other countries surveyed, other than the US and Switzerland, and double those of France and Britain.
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Dutton cautious on tiered Medicare rebates

Joanna Heath
Health Minister Peter Dutton has signalled reluctance to introduce a tiered system of Medicare rebates, arguing it would make the system too complicated for doctors.
“I want our health system to be sustainable,” Mr Dutton told ABC Radio.
“The point I’d make is you don’t want to introduce extra complexity and bureaucracy into the system.
“I want to have a more simple system. We have to do it in a sustainable way.”
Labor and the Greens have come out in fierce opposition to a proposal put together by the Department of Health before last year’s budget that would see bulk billing limited to concession card holders and children, with lower rebates given to those on Family Tax Benefit A and the rest of the majority adult population. Mr Dutton’s office refused to rule out accepting the proposal on Thursday.
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Dutton: insurers could have a larger role in primary care

Joanna Heath
Health Minister Peter Dutton supports private health insurers entering the primary care sphere and says the government is willing to provide help through Medicare.
Mr Dutton made his most detailed comments yet about potential models that would allow private health insurers to contribute to costs for GP visits at a speech in Brisbane on Monday.
He said he supported private health insurers having a role that would allow them to intervene earlier with chronically ill patients, which would save money for insurers and taxpayers.
“My main objective is to help people improve their health and where possible enhance the primary care offering so as to avoid those future interventions,” Mr Dutton said. “I would find it very difficult to see any system changes in this space where insurers were picking up out-of-pocket expenses for patients – that is delivering free services. We are willing to provide some support through Medicare, but not beyond that.”
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Health system concerns over primary care changes

Joanna Heath
Changes made by the Abbott government in primary care will stop short of allowing private insurers to cover ­out-of-pocket GP fees, and most likely be limited to a form of information sharing.
Trials being undertaken by Medibank Private in Queensland, where the insurer has cut a deal with a chain of GP clinics to cover some administrative costs in return for their customers avoiding a so-called “gap” fee, is not being considered by the government as a preferred model. There are concerns that if such a model were rolled out nationwide it could lead to a divided healthcare ­system, where privately covered patients are treated differently to those on Medicare.
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Comment:
Mr Dutton has given 2 major speeches rehearsing the huge present costs of Health System and all the new expensive technologies which will add dramatically to the bill over the next few years. You can be sure he is hoping to keep that growth as low as possible - by hook or by crook!
The float of Medicare Private is clearly part of the plan. One can only hope privatising the largest health insurer does not result in premium rises for you and me.
To remind people there is also a great deal of useful discussion here from The Conversation.
As usual - no real news on the PCEHR Review.
More next week.
David.

Tuesday, April 01, 2014

What Is Going On With The Electronic Recording and Reporting of Controlled Drugs System? It Is Hardly Clear!

This article appeared a few days ago.

Ministers’ bid to beat painkiller addiction

PAINKILLERS and tranquillisers would be sold in smaller packs and subject to online tracking under a plan to address the growing problem of pharmaceutical drug abuse.
A new framework endorsed by health ministers says greater availability of opioids and benzodiazepines in Australia in recent years has caused more addiction, overdoses, trafficking and crime. With the ageing population, there is concern the prevalence of painful conditions and anxiety disorders will only increase, raising the risk of a new older generation of drug addicts.
The experts who developed the framework believe doctors and pharmacists need support to ensure the correct use of medicine and, along with consumers, may need to be made aware of other options — including non-drug alternatives — for treatment of pain, mental health problems, sleep disorders and addiction.
A priority will be the launch of a national Electronic Recording and Reporting of Controlled Drugs System, providing real-time alerts about problem customers or dispensers, along with tougher regulations.
More here:
This seems to have been going on for quite a while!

Delayed choice for prescription alert platform

HEALTH Minister Tanya Plibersek's $5 million plan to crack-down on prescription painkiller abuse, which was announced in February, was originally funded under the fifth community pharmacy agreement with the Pharmacy Guild in 2010.
However, a decision on the platform was reached only late last year.
Ms Plibersek was responding to calls from a Victorian coroner for action on real-time prescribing and dispensing monitoring systems for controlled (Schedule 8) drugs, including the ability to alert doctors before new scripts are issued.
In February, coroner John Olle found James, a 24-year-old Melbourne man, had committed suicide by overdosing on morphine and diazepam; in the three years before his death, James had obtained S8 scripts from 19 doctors and medications from 32 pharmacies.
A spokesman for Ms Plibersek told The Australian a Tasmanian-developed drugs and poisons information system with web-based remote access would be expanded to support a nationwide rollout commencing in July.
Lots more here:
The original announcement was reported here:

Government wages war on painkiller abuse

Posted Wed, 15/02/2012 - 12:02 by Josh Gliddon
A system pioneered in Tasmania is being expanded Australia-wide in a bid to combat prescription painkiller abuse.

The federal government is licensing the Electronic Recording and Reporting of Controlled Drugs system from the Tasmanian government, and rolling it out to health professionals at a cost of $5 million.

Clinicians and other health professionals who prescribe prescription painkillers, such as oxycodone, morphine and codeine, will be able to log into a central database containing prescription records.
More here:
Note the system was meant to be online July 2012!
Here is a link to the provider of the system’s blog:

Electronic Recording and Reporting of Controlled Drugs

20 Aug 2013/in Uncategorized /by admin
XVT is excited to announce our involvement in the provision of a national system that will collect information on all dispensing events related to Controlled Drugs, which is one of the initiatives to be implemented under the Fifth Community Pharmacy Agreement between the Australian Government and The Pharmacy Guild of Australia. The national solution will monitor the use of controlled drugs and provide a decision support tool for health professionals to assist in clinical decision making related to these medicines.
From 2008 we have designed, developed and implemented an electronic solution for the Tasmanian Government that records and provides real-time reports on the dispensing of controlled drugs. This has been successfully rolled out to the state health authority, pharmacies and health facilities in Tasmania and been in operation for over 12 months
More here:
So what we seem to have here is a priority to implement a system which was announced by the previous Government over 2 years ago suddenly renewed.
So there is a big delay here. If it is such a great idea I wonder what the holdup is? Two question are just how good is the idea in the context of the overall health system and just what has been the holdup.
Comments more than welcome - to explain just what is actually going on!
David.