Sunday, June 30, 2013

The Lack Of Organisation In Health Information In Australia Is Putting Lives At Risk. I Fear The Root Causes Will Never Get Fixed.

This letter to DoHA appeared last week

Changes to generic description for PBS medicines with multi-ingredients

24 June 2013
Download the PDF document (297KB) titled "Joint Letter re Generic Listing of multi-active PBS Medicines"
Here is the letter:
17 June 2013
Mr Paul Madden
Deputy Secretary and Chief Information and Knowledge Officer
Department of Health and Ageing
GPO Box 9848
Canberra ACT 2601
Dear Mr Madden

Re: Changes to generic description for PBS medicines with multi-ingredients

The undersigned groups represent the medical profession, the pharmacy profession, the medical software industry and the professional indemnity insurance sector. We are writing to you to urge immediate action, led by the Department of Health and Ageing, in relation to a serious issue affecting the safe prescribing and dispensing of PBS medicines.
The decision to change the generic description of multi-active PBS medicines to an alphabetical listing in the PBS Schedule is causing confusion for pharmacists, difficulties for prescribers and software vendors and safety concerns for consumers. Alphabetising the listing of active ingredients in multi-active products to be consistent with Australian Medicines Terminology (AMT) has resulted in the generic descriptions imported by software vendors from the PBS data to be displayed for drug selection in a manner conflicting with the packaging and product description approved by the Therapeutic Goods Administration (TGA).
This results in listing incorrect information regarding the strength of the ingredients and raises the possibility of the incorrect item being supplied. We are concerned that decisions are being made to arbitrarily change the generic description of medicines with multi-active ingredients without consideration of the impact on pharmacists and prescribers, consumers, the medical software industry or manufacturers. We believe that broad consultation with all relevant groups should be undertaken before any changes are made and the TGA be consulted as a priority as it is currently conducting a review into the labelling and packaging of medicines.
Examples of medicines that are affected are included in Attachment A, including multi-active products that may be impacted with future changes. While this is not a complete list, it indicates that more consideration needs to be given to any changes in the generic description of multi-active PBS products.
It is important to note that this issue was raised with the PBS Information Management section of your Department in the first week of May, as soon as the safety issues relating to the Coveram and Reaptan brands were identified. However the problem has been carried through to the June Schedule and now to the July Schedule, with more examples now identified.
The changes already implemented have caused significant confusion and consternation with health care professionals (see Attachment B), and increases the safety risks to consumers frompotential supply errors.
The undersigned groups request that these changes be immediately reversed, ahead of implementing a consultation with all relevant stakeholders to review the impact of such changes and consider if, when and how such changes are to be implemented in a manner that manages any negative outcomes. This consultation must also consider steps necessary to avoid other PBS schedule implementation issues such as the PBS item code confusion resulting from the rosuvastatin listings from 1 June 2013 and the inability for dispensing software or prescribing software vendors to test for PBS Schedule file issues prior to the date of effect of each Schedule.
We look forward to your urgent attention to this issue. Email addresses have been included below to allow for communication with the most relevant people in all the undersigned groups.
Yours sincerely
Prof Geoff Dobb
Vice President  
Australian Medical Association
(Email contact: bhighmore@ama.com.au)
Kos Sclavos
President
The Pharmacy Guild of Australia
 (Email contact: stephen.armstrong@guild.org.au)
Grant Kardachi
President
Pharmaceutical Society of Australia
(Email contact: peter.waterman@psa.org.au)  
Marie Ritchie
Chief Executive Officer
PDL (Pharmaceutical Defence Limited)
(Email  contact: Marie.Ritchie@pdlappco.com.au)
Bridget Kirkham
Chief Executive Officer
MSIA
(Email contact: ceo@msia.com.au)
All the attachments can be downloaded from here:
All I need to say about this is that this is a clear cut example of how lives can be put at risk when bureaucrats - despite warnings - just go ahead and implement changes which affect the operation of clinically important software.
Now - just to make sure we have even more confusion we have this:

Consultation: International harmonisation of ingredient names

15 May 2013
This consultation closes on 10 July 2013

International Harmonisation of Ingredient Names - Consultation paper

Here is what it is about:

“About the consultation

The TGA maintains a list of approved names for medicines ingredients in the form of the TGA Ingredients database. The World Health Organization's International Non-proprietary Name (INN) terminology has been adopted for new medicines ingredients as standard policy wherever possible from 2002 onwards. However, several hundred ingredients added to the ARTG prior to this time have names inconsistent with INN terminology, and require harmonisation.
The proposal put forward in this consultation is to harmonise the names of these ingredients contained within medicines, not the names of the medicines themselves. The vast majority of the proposed ingredient name changes are minor, consisting of a single letter change (e.g. amoxycillin to amoxicillin; oestrogen to estrogen; cholecalciferol to colecalciferol).
The proposed changes may affect sponsors of the following products:
  • prescription medicines
  • over the counter medicines (including sunscreens)
  • complementary medicines (both registered and listed)
  • Export Only medicines
Consumers who use products that contain these ingredients, and healthcare professionals who prescribe and dispense them will also be affected.
Feedback received from these different stakeholder groups as part of this consultation will be used to determine an appropriate strategy to implement the changes in a way that presents the least possible inconvenience to stakeholders.”
-----
So we are just going to change a few hundred spellings and create extra work for all sorts of people.
I wonder is all this being co-ordinated with the solution to the first issue raised? I fear not.
Bottom line is that again we have the failure of leadership and governance in the e-health space. Sadly I don’t see either side of politics (new or old) having the will or wit to improve things. I wish I could be proven wrong.
Exhausting isn’t it.
David.

Saturday, June 29, 2013

Weekly Overseas Health IT Links - 29th June, 2013.

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.
-----

FDA Warns of Malware on Medical Devices

JUN 17, 2013 3:03pm ET
The Food and Drug Administration has issued a warning and guidance about cyberattacks that could place malware on medical devices and affect configuration settings:
FDA Safety Communication: Cybersecurity for Medical Devices and Hospital Networks
Date Issued: June 13, 2013
Audience: Medical device manufacturers, hospitals, medical device user facilities, health care IT and procurements staff; and biomedical engineers
Issue: Cybersecurity for medical devices and hospital networks
Purpose: The FDA is recommending that medical device manufacturers and health care facilities take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack, which could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks.
Summary of Problem and Scope: Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches. In addition, as medical devices are increasingly interconnected, via the Internet, hospital networks, other medical device, and smartphones, there is an increased risk of cybersecurity breaches, which could affect how a medical device operates.
-----

4 ways healthcare is taking advantage of 3-D

June 21, 2013 | By Ashley Gold
We may be closer than ever to understanding the complex anatomy of the human brain, thanks to the introduction of a new three-dimensional tool that has created a digital reconstruction of the human brain, called the BigBrain.
The tool, which show brain anatomy in "microscopic detail," was developed by German and Canadian researchers and outlined in the June 21 issue of Science, according to an announcement from the American Association for the Advancement of Science. According to the Washington Post, the researchers used a 65-year-old woman's brain, cut into 7,400 slices, in building the atlas.
-----

Password problems plague plethora of med devices

June 21, 2013 | By Dan Bowman
Roughly 300 medical devices from 40 vendors were found to have password vulnerability problems, according to an alert recently issued by the Department of Homeland Security.
The vulnerabilities, GovInfoSecurity reported, were discovered by a pair of researchers working for Irvine, Calif.-based security vendor Cyclance. One of those researchers--Billy Rios--told GovInfoSecurity that that he and his colleague found the vulnerabilities in "backdoor passwords" typically only known to vendors.
-----

ONC's Ricciardi gives consumers voice

Posted on Jun 18, 2013
By Anthony Brino, Associate Editor, Healthcare Payer News and Government Health IT
Lygeia Ricciardi became the first director of the ONC’s Office of Consumer e-Health in In May 2012. The office evolved from the Office of Policy and Planning as CMS and HHS leaders started realizing the central role of individuals in the grand scheme of American healthcare and its reform.
Ricciardi’s office acts as a sort of consumer voice in ONC policymaking and tries to help HIT policy stakeholders think about mobile health and health IT from a patient’s perspective. Another part of the work is helping patients understand their legal personal information rights and the benefits of managing their own data via apps like the Blue Button.
With consumer technologies becoming more affordable at a time when 30 million Americans are getting newly insured, Ricciardi and other federal health officials see a good opportunity to try to align the patient empowerment goals of the Affordable Care Act with the new care delivery and management possibilities offered by health IT.
-----

Health system to include sexual orientation, gender info in EHRs

June 19, 2013 | By Marla Durben Hirsch
To improve the care provided to lesbian, gay, bisexual and transgender patients, questions about sexual orientation and gender identity soon will be "standardized demographic elements" in the University of California, Davis Health System's electronic health record systems, according to a June 17 announcement.  
The health system--located in Sacramento--will be the first academic health system in the nation to incorporate such information as standard elements in its EHR.
-----

EHRs can improve patient-physician interaction

June 19, 2013 | By Marla Durben Hirsch
Electronic health records, which have long been maligned as disruptive to the patient/physician relationship, can be used to enhance communication and interaction, according to an article published in the Journal of the American Medical Association.
The authors, physicians from the National Institutes of Health, note that EHRs already can be used for electronic messaging with patients, and to provide patient's access to their records and educational resources. But EHRs also create "new possibilities" to encourage dialogue and have a positive effect, they say.
-----

Insurance exchanges running late

Posted on Jun 20, 2013
By Bernie Monegain, Editor
Two GAO reports reveal that health insurance exchanges – websites where consumers and employers can shop for healthcare insurance – could miss their Oct. 1, 2013 deadline. However, Department of Health and Human Services officials said in a response published in the reports they were confident the exchanges would be open and functioning in every state by the target date.
The exchanges, required under the federal health reform law, are expected to provide healthcare coverage for 7 million people in 2014, and 22 million by 2016.
One report examines efforts by the Centers for Medicare & Medicaid Services; the other explores how far along state and federal governments are in the process.
-----

NHS urged to use IT safety standards

19 June 2013   Kim Thomas
Trusts should adhere to patient safety standards when implementing new IT systems, a patient safety expert has argued.
Maureen Baker, clinical director of patient safety at the Health and Social Care Information Centre, told last week's UKRC that although the last 20 years had seen an increasing awareness of the importance of patient safety, there was still much to be done.
In the US, for example, an estimated 98,000 people a year die from medical errors occurring in hospital.
-----

The Big EPR Debate: round table

NHS England is getting ready to issue the guidance that will shape the latest bid to digitise the health service. Given a last chance to influence the content, participants in The Big EPR Debate round table focused on money and practicalities. Lyn Whitfield reports.
19 June 2013
Health secretary Jeremy Hunt made his speech calling for the NHS to become paperless by 2018 at the end of January.
The best part of six months later, NHS England is within weeks of issuing guidance on the first step; how trusts should plan to implement electronic patient record systems.
Trusts will be expected to have plans in place by April. So there is a real sense that the NHS is starting to get to the business end of the latest attempt to digitise the health service.
That may explain why The Big EPR Debate round table organised by EHI earlier this week was so focused on money, on the detail of how to shake up the healthcare IT economy, and on the finer points of leadership for change.
-----

UPMC data warehouse allows integration of clinical, genomic data

June 20, 2013 | By Susan D. Hall
With a data warehouse's foundational architecture in place as part of the University of Pittsburgh Medical Center's $100 million analytics effort, researchers recently were able to electronically integrate clinical and genomic information on 140 breast cancer patients. 
The researchers are trying to determine whether there are differences between pre-menopausal and post-menopausal breast cancer. They started with just two types of data: gene expression and copy number variant data, measuring changes in the amount of DNA. But they expect to add many more, according to an announcement.
UPMC plans to mine and integrate massive amounts of data, including clinical, genomic, proteomic, imaging and financial that previously resided in separate information systems. Combining the different datasets will allow researchers to analyze dozens of variables.
-----

ED Tries Telemedicine in Bid to Cut Wait Times

Cheryl Clark, for HealthLeaders Media , June 20, 2013

A medical center with long emergency department wait times is running a pilot study to test whether telemedicine can connect doctors to the virtual bedside of waiting patients much faster.
That University of California San Diego Medical Center doctors would try something new in an effort to make their emergency care more efficient makes sense for a bunch of reasons.
The 505-bed dual-campus hospital is a major teaching and research center supported by the state. It treats large numbers of uninsured and very sick patients. Its emergency rooms are usually very busy.
And the patients who go there endure insufferable waits that average 296 minutes—longer than at 11 other major hospitals in the county and double the national average—before they are sent home, according to the latest wait times posted on Hospital Compare.
-----

Patient/Physician Portals, a Stepwise Approach – Part 2

JUN 17, 2013 11:01am ET
As you may recall from last month’s article, in the world of health care I.T., there is a focus on portals. These portals are built to meet Meaningful Use Sections 170.304(h) and 170.306(d), which provide patients with the ability to access clinical summaries, as well as health information. 
Portals, if well built, facilitate communications with patients and doctors using a common set of data, and they put the data into a more understandable context for the doctor. Moreover, the use of portals increases the amount of meaningful data that’s available within the portals.  This includes leveraging analytics built around local and remote big data systems that provide the ability to validate diagnostics and treatments against massive amounts of historical treatment and outcome data. 
-----

Q&A with Farzad Mostashari, MD

Posted on Jun 19, 2013
By Diana Manos, Senior Editor
National Coordinator for Health Information Technology Farzad Mostashari, MD, spoke with Healthcare IT News Senior Editor Diana Manos Monday at the HIMSS Media ICD-10 Forum in  National Harbor, Md.  With his typical candor and energy, Mostashari commented on several healthcare IT issues and about ICD-10 – the focus of the forum and the topic of the keynote talk he had delivered earlier in the day. Yes, he was wearing his signature bow tie.
Q. How did you get so passionate about healthcare IT?
A. I went to the school of public health first, thinking I was going to help populations and do international work, and then my Dad got sick. He was in the hospital and I thought – my gosh, this laying on of hands, that is something really powerful – and, so I went to med school. There’s an indispensible role of healthcare in easing suffering. Information and information tools help us apply the best care to an individual based on everything we’ve learned and to have that individual encounter contribute to the greater knowledge. That tension [between] the many and the one is very personal to me.
-----

NHS runs up £31.5m Fujitsu dispute bill

12 June 2013   Lis Evenstad
The NHS has run up £31.5m in legal costs as a result of Fujitsu’s departure from the National Programme for IT in the NHS in 2008.
Questioned at the Common’s Public Accounts Committee this afternoon, Tim Donohoe, who has become senior responsible owner for the local service provider programmes at the Department of Health, confirmed a legal dispute with the company was ongoing.
He said an “evidence phase” had concluded and an arbitration panel would decide on what, if any, compensation Fujitsu should receive.
-----

Tech fund to 'catalyse' NHS IT - Bryant

19 June 2013   Lyn Whitfield
The £260m fund announced by the Department of Health as a boost for e-prescribing will be linked to NHS England’s guidance on electronic patient records to “catalyse” the adoption of IT in the NHS.
Beverley Bryant, the director of strategic systems and technology at NHS England, told EHI’s The Big EPR Debate round table that linking the two would give the guidance traction.
“Call me an old cynic, but I think there is more chance of people reading it [the guidance] if there is an application form at the back to get hold of the money,” she told the event in central London yesterday.
-----

Poor USB security puts info for 6 million Medicare beneficiaries at risk

June 19, 2013 | By Dan Bowman
A Medicare contractor's failure to adequately implement security controls over USB devices put sensitive information for more than six million Medicare beneficiaries at risk, according to a report published this month by the U.S. Department of Health & Human Services Office of Inspector General.
The contractor--Columbia, Md.-based Quality Software Services, Inc.--is responsible for independent testing services for changes to Medicare Part A and B "Fee-for-Service" standard systems. OIG found that QSSI did not list "essential system services or ports" in its security plan, nor did it disable, prohibit or restrict use of unauthorized USB device access. According to the report, QSSI failed to implement USB security controls "because its management had not updated its USB control policies and procedures."
-----

Lots of Americans Want Health Care Via Their Smartphone

But all too often, the demand outpaces the technology to deliver it, Harris Interactive/HealthDay poll finds

June 18, 2013
By Amy Norton
HealthDay Reporter
TUESDAY, June 18 (HealthDay News) -- Plenty of Americans are eager to use their mobile phones and tablet computers to better manage their health care, a new poll finds -- though the nation has a way to go before we're all consulting Dr. Smartphone.
In a Harris Interactive/HealthDay survey released Tuesday, more than one-third of respondents who are online said they were "very" or "extremely" interested in using smartphones or tablets to ask their doctors questions, make appointments or get medical test results.
Similar numbers of respondents were eager to use mobile phones and tablets for actual health-care services -- such as monitoring blood pressure or blood sugar, or even getting a diagnosis. Such phone and tablet apps are, however, either just getting off the ground or not yet on the market.
-----

NHS England to unleash people power

14 June 2013   Rebecca Todd
NHS England will release an NHS technology strategy for the next decade - called ‘Unleashing the power of people’ - this December.
Beverly Bryant, NHS England’s director of strategic systems and technology, spoke at the Commissioning Show in London on Tuesday.
She said the new strategy would draw a line under the past and some of the old national programmes.
It will include details of support to attract people to work in the NHS from the private sector, as well as apprenticeships to make sure the NHS has the skills to make the digital transformation.
-----

Facebook boosts organ donor registration

June 18, 2013 | By Ashley Gold
Researchers from Johns Hopkins University in Baltimore found that a social media push boosted the number of people who registered themselves as organ donors 21-fold in a single day, they announced this week. To that end, the researchers suggested that social media could be a tool in addressing America's current stubborn organ shortage.
The increases were made in May 2012, when Facebook created a way for users to share their organ donor status with friends and also provided easy links to make their status official on state department of motor vehicle websites. The findings are being published in the American Journal of Transplantation.
-----

Sharing Electronic Medical Records Still Too Hard

Epic CEO Judy Faulkner and other health execs aren't thrilled with the state of EHR interoperability. What are today's big barriers?
The average patient can't fathom why the sharing of electronic medical records is so hard. But those inside healthcare aren't thrilled either with the state of electronic record interoperability, as several smart discussions at this week's Digital Healthcare Conference in Madison, Wis., showed.
"If we're this far into this implementation across the country, and we still have this level of discordance, shame on us," said Dr. Frank Byrne, president of Wisconsin's St. Mary's Hospital. "How did we get here and how do we get out? Because we've created barriers." AdTech Ad
Epic CEO and founder Judy Faulkner highlighted some of the obstacles to data sharing, from patients wanting to control such sharing, to difficulty training clinicians, to the many technical challenges. While data-definition standards in theory should make sharing easier, "the standards are only describing a very, very small subset of the data that's really there," Faulkner said.
-----

Hacking Healthcare is Fred Trotter's Passion

Scott Mace, for HealthLeaders Media , June 18, 2013

Fred Trotter is closing the gap between the needs of patients and providers to see and share data, and the reality of unlocking it from where vendors have stored it. Driven by a passion for transparent access to data, he's just getting started.
Patients have caregiver champions. They have physician champions. They have nurse champions. They have payer champions. And, I discovered recently, they have at least one hacker champion.
His name is Fred Trotter, and if you're a proprietary software vendor, you don't want to make him angry.
First, forget any automatic association you have between the word hacker and criminal activity. Some hackers break laws. Most do not. As described in Steven Levy's classic book Hackers, computer programmers are a culture unto themselves, and the hacker ethic states: "Access to computers should be unlimited and total." Ironically, we live now in an age where the National Security Agency has made that its mission. As for hackers like Fred, they know that they won't get too many programming jobs if they totally disregard laws.
-----

Quebec to expand $1.6 billion EHR

Posted on May 28, 2013
By Erin McCann, Associate Editor
Quebec province in eastern Canada is poised to roll out a $1.6 billion electronic health record system across all 17 regions of the province after seeing marked success with four regional pilot programs.
Quebec Minister of Health and Social Services Rejean Hebert announced Monday that starting summer 2013, the Quebec Health Record will be gradually extended to all province regions, reaching more than eight million people by 2015's end. 
"We turn now to an experimental project in only four regions to a specific national project," said Hebert, in a press statement. The QHR was initially deployed back in 2008, in the Capitale-Nationale region.
-----

NHS ups patient privacy

Posted on May 30, 2013
By Jamie Thompson, Web Producer
As part of its strategy to become a leader in the “paperless NHS” initiative, Cumbria Partnership NHS Foundation Trust has chosen a new patient privacy solution. The FairWarning Patient Privacy Monitoring solution will protect current patient records at the trust.
"Following a review to ensure that we had in place a model for information sharing, we saw privacy as being key to developing our reputation as a trusted provider of healthcare services to the public," said Yvonne Salkeld, head of information governance at the trust.
-----

ECRI: 10 ways to cut health IT risks

Posted on Jun 17, 2013
By Bernie Monegain, Editor
ECRI Institute, an independent, nonprofit organization that researches the best approaches to improving patient care, has released a new report, Risk Managers’ 10 Strategies for Health IT Success.
Based on ECRI’s research and interviews with risk managers and health IT safety experts, it identifies top tips to guide a risk management approach to health IT.
-----

Providers navigate potential uses for Google Glass in healthcare

June 17, 2013 | By Ashley Gold
It's time to think about how physicians--and not just techies at Google Headquarters--can use Google Glass. For example, Rafael Grossman, a surgeon at Eastern Maine Medical Center in Bangor, can think of a few ways he'd use the technology, as he outlines in a new blog post.
"I imagine performing an operation and connecting live with [a] group of students or surgeons, anywhere, doing a live 'Hang Out,' letting them virtually 'BE' in the OR with me, seeing what I'm seeing, pointing to anatomic structures and different steps of the procedure, [through] my eyes," Grossman writes.
-----

Despite progress on health IT interoperability, tough questions remain

June 17, 2013 | By Susan D. Hall
Data-sharing in healthcare remains difficult, and despite assertions that the industry is on the cusp of a breakthrough, many are impatient with the slow pace of progress.
Those attending the Digital Healthcare Conference in Madison, Wis., last week addressed some of the biggest questions about the sad state of interoperability, according to InformationWeek.
-----

EHRA code of conduct only a baby step toward greater patient safety

June 13, 2013 | By Marla Durben Hirsch
I read with great interest the HIMSS Electronic Health Record Association's new EHR Developer Code of Conduct, released this week. The much-anticipated document--created by EHRA with the help of government, provider and consumer stakeholders--is intended to be an "accurate communication" about the functionality and benefits of EHR products and services.
It's already been heralded by the EHR vendor industry. Siemens CEO John Glaser called the document an "important milestone in the maturation of the healthcare information technology industry," adding that he thinks it "will propel our industry's ability to deliver safer, more effective and more interoperable solutions." SRSsoft adopted and "fully" endorsed the document within hours of its release, as well.
-----

AHRQ Releases Guide to Help Primary Care Practices Use HIE

Written by Anuja Vaidya  | June 13, 2013
The Agency for Healthcare Research and Quality has released a guide called "Regional Health eDecisions: A Guide to Connecting Health Information Exchange in Primary Care," which outlines a framework for primary care practices to connect to regional health information exchanges.
-----
Monday, June 17, 2013

Update on Federal HIE Governance Activities

The Health Information Technology for Economic and Clinical Health Act charged the Office of the National Coordinator for Health IT with establishing a governance mechanism for the nationwide health information network (NwHIN). While ONC initially intended to govern the NwHIN through regulation, it changed course in September 2012 and chose to follow a non-regulatory approach, which would be more agile and responsive to the evolving NwHIN.
Background
ONC defines governance to mean the establishment and oversight of a common set of behaviors, policies and standards that enable trusted electronic health information exchange among a set of participants. ONC has publicly stated that its overall goal for HIE is that information will follow the patient where and when it is needed, across organizational, vendor and geographic boundaries.
On May 11, 2012, ONC issued a request for information to gather public input on a potential HIE governance strategy that would have spelled out "conditions for trusted exchange" through regulation and would have established a voluntary accreditation and certification process for validating organizations as being legitimate participants in the NwHIN. ONC started with an RFI because it recognized that the HIE marketplace was (and still is) in its infancy, and it wanted to obtain broad input before developing a regulation.
-----

Enjoy!
David.