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, October 22, 2011

Weekly Overseas Health IT Links - 22 October, 2011.

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.
-----

Health information technology: Incentives may not always serve intended purpose

Survey suggests some awards are going to doctors who have been using electronic health records for years

By Josh Israel and Kimberly Leonard

7:30 am, October 12, 2011

About half of the first batch of federal dollars meant to encourage doctors and hospitals to switch to electronic records went to providers who were converts to the technology long before the stimulus program was announced, an iWatch News analysis suggests.
The analysis could raise questions about whether the government will be able to meet its goal of widespread adoption of health information technology. While these early numbers are hardly conclusive, they suggest that a large swath of payments intended to be an incentive for new adoption of electronic health records are merely rewarding health providers for minor adjustments to systems they have had in place for years.
-----

Fed Advisors: Too Soon to Add EHR Metadata to Meaningful Use

HDM Breaking News, October 13, 2011
The Office of the National Coordinator's plan to require use of EHR metadata in Stage 2 of the meaningful use program is premature, according to the National Committee on Vital and Health Statistics, a federal advisory body.
ONC in August issued an advanced notice of proposed rulemaking, laying out its initial thoughts about metadata and seeking public comment. Adoption of EHR metadata standards, which the President's Council of Advisors on Science and Technology has advocated, could help improve data exchange and would enable patients to segregate parts of their medical records, such as self-paid treatment for sensitive conditions.
-----

Who should pick up the tab for EHRs?

October 11, 2011 | Jeff Rowe, HITECH Watch
While many providers have decided to transition from paper records to EHRs, many others have not, and cost seems to be one of the main reasons for the reluctance.
That fact in mind, this regular observer raises an interesting question: Who should be paying for EHRs?
“EHRs are by and large a complex and expensive proposition,” she points out early on, “and the HITECH incentives are not covering the average cost of purchasing and maintaining an EHR. In survey after survey, physicians consistently rank cost associated with EHRs as their top concern when considering transition from paper charts to electronic medical records. This is a bit disconcerting, since physicians have no problem buying other expensive tools and paying for human resources in their practices. How are EHRs any different?”
-----

Healthcare IT funding, M&A activity surges

October 11, 2011 | Molly Merrill, Associate Editor
AUSTIN, TX – Venture capital funding and merger and acquisition activity in the healthcare IT sector saw significant growth in the third quarter of 2011, according to a report from global communications and consulting firm Mercom Capital Group.
The report shows that VC funding for healthcare IT in Q3 more than tripled, with $207 million in 17 deals compared to $66 million in six deals in the previous quarter. VC funding for the same quarter last year came to $62 million in seven deals. Fifty different investors participated in these funding rounds.
-----
  • October 12, 2011, 2:24 PM ET

Guideline Experts Have Conflicts of Interest, Study Finds

Ever wonder who’s behind the new recommendations for, say, how to treat high cholesterol or whether to screen men for prostate cancer? More specifically, do you ever wonder whether experts on the panels that develop guidelines have financial ties to pharma or device companies that might be affected?
The Institute of Medicine recommends that ideally, guideline developers shouldn’t have any financial investments in companies that stand to benefit from recommendations, nor should they (or family members) participate in marketing activities or advisory boards of those companies.
Sometimes it’s not possible to convene an entirely conflict-free panel, in which case members with financial ties to industry should be only a minority of the panel, the IOM says. Panel chairs or co-chairs should not have conflicts at all, and industry shouldn’t have a role in developing the guidelines, the group says.
-----

Be wary of legal pitfalls when joining an HIE

October 12, 2011 — 9:36pm ET | By Marla Durben Hirsch - Contributing Editor
One of the biggest draws of adopting electronic health records is the ability to share patient information electronically via health information exchanges (HIEs) cropping up across the country. However, there are legal considerations that providers should be aware of when joining an HIE, according to an article in the October 2011 issue of the Journal of AHIMA.
-----

Younger doctors expect to use EHRs

October 12, 2011 — 9:38pm ET | By Marla Durben Hirsch - Contributing Editor
It appears our neighbors to the north are going through similar growing pains regarding electronic health record adoption by older doctors, according to a new survey. The National Physician Survey, Canada's largest survey of physicians and physicians in training, found that while residents and younger providers expect to use EHRs upon graduation, 39 percent of current physicians are using EHRs, while 37.6 percent of docs choose to only use paper.
The survey, published September 28, found that 78.6 percent of all residents have used or been exposed to EHRs as part of their medical training. What's more, 81.5 percent of family medicine residents expect to use EHRs rather than paper records when they go into practice, an increase from 75 percent in 2007 (the last time the NPS survey was conducted). More than 2,500 residents responded to the survey.   
-----

All Birmingham patients to get MyHealth

11 October 2011   Shanna Crispin
All long term condition patients at University Hospitals Birmingham NHS Foundation Trust are to be given the ability to access, share, and add to their health records.
The trust’s IT team developed a web-based patient portal for liver patients, which was trialled with 12 patients earlier this year.
Director of informatics, Daniel Ray, told eHealth Insider the project was now going to be rolled out to include all patients with long term conditions being treated at the trust.
“The potential for this is huge” Ray said. “Over the next few years we expect to have between 12-15,000 people accessing it.”
-----

JAC wins Northern Ireland e-prescribing

13 October 2011   Shanna Crispin
Hospitals across Northern Ireland are to get a standard electronic prescribing and pharmacy management system from JAC.
Northern Ireland Health and Social Care (HSC) has awarded JAC a contract for pharmacy software to be rolled out in all its 38 hospitals. 
The contract represents the largest single e-prescribing and medicines management deal yet awarded in the UK.
-----
Thursday, October 13, 2011

Facebook and EHRs: A Very Fine Line Just Got Even Finer

Americans love their privacy. And yet, as the ever-increasing trend of social networking illustrates, they also love to share the facts of their lives. As a result, defining privacy can be tricky in this modern age and often depends on the venue in which information is presented and the form it takes.
In today's world of electronic health records, straddling the fence between harmless information and sensitive data is no longer such an easy task, and the repercussions for the slightest transgression can be severe.
On Aug. 22, HHS issued a press release challenging software developers to create new Facebook applications to assist in emergency preparation efforts. If Facebook was a nation, its "population" would be more than double that of the United States. If online minutes for Facebook users were the functional equivalent of "dollars spent," the social network's estimated $84 trillion in annual "spending" would top the collective gross national products of all nations across the globe, even if the U.S. or European Union were counted twice.
-----

Federal Advisors Seek Easier Secondary Use of EHR Data

HDM Breaking News, October 12, 2011
The HIT Policy Committee has issued recommendations to ease secondary uses of electronic health records data.
In particular, use of EHR data for treatment purposes or to evaluate the safety, quality and effectiveness of prevention and treatment activities should not require patient consent, institutional review board approval or even minimal registration, according to the federal advisory body.
The committee believes the Department of Health and Human Services "could take the approach of not labeling these activities as 'research' but instead should consider them to be treatment or operations if conducted by, or on behalf of (such as by a business associate), a provider entity." Providers, however, should always use the minimum necessary amount to accomplish the task.
-----

6 tips for HIE sustainability

October 07, 2011 | Michelle McNickle, Web Content Producer
The widespread development of health information exchange is happening quickly, and with it comes worries about confidentiality, privacy and security. But its benefits far outweigh potential concerns and include improved quality of care and reduced healthcare costs. 
Despite HIE’s reserved reception among hospitals and practices nationwide, many have said it will play a significant part in meaningful use stages down the road. And since there’s no time like the present to get a jump start on beneficial programs, Rob Brull, product manager at Corepoint Health, suggested six tips to make HIE implementation last.
-----

Successful eRx requires 'three-phased approach'

October 06, 2011 | Molly Merrill, Associate Editor
NEW BRUNSWICK, NJ – A new study profiling how five physician practices successfully overcame their e-prescribing challenges has determined that the common thread among them was that each had carefully moved through three phrases: planning, implementation and use of the systems.
The research was led by Jesse Crosson at UMDNJ-Robert Wood Johnson Medical School and identified key techniques in the implementation and use of electronic prescribing.
-----

Electronic records help boost elders’ preventive care

October 03, 2011|By Chelsea Conaboy, Globe Staff
Researchers at Beth Israel Deaconess Medical Center found that primary care doctors could improve preventive care for elderly patients by creating reminders in their electronic records system.
The researchers developed a tool that prompted physicians to check whether patients over age 65 had assigned a health care proxy, been screened for osteoporosis, or had received vaccines for flu and pneumonia.
The study included 54 physicians, about one-third of whom followed their usual practices with their existing records. The others were given the reminder tool; half of those were given help by an administrative assistant who contacted patients with reminders.
-----

A practical guide: Beginning the EMR journey

October 10, 2011 | Ilene Yarnoff, Lead assurance and resilience principal, Booz Allen Hamilton
The migration to electronic medical records offers patients, providers and the overall healthcare system a variety of compelling benefits and cost reductions — but we shouldn’t underestimate the challenges that stand between the idea of an e-health ecosystem and it becoming a reality.
Specifically, there’s a significant amount of work to be done around privacy, information security, compliance, and identity and payment fraud.
-----

3 Tips for surviving an OCR breach investigation

October 10, 2011 | Rick Kam and Christine Arevalo, director of healthcare identity management, ID Experts
or many healthcare organizations, a dreaded acronym may well be OCR—the U.S. Department of Health and Human Services (HHS) Office for Civil Rights. With fines and enforcement of the HIPAA Privacy and Security Rules on the rise, it’s natural for collective muscles to tense in anticipation of an OCR investigation.
After all, non-compliance means any violation of the HIPAA rules—from improper disclosure of protected health information (PHI) to denying access to medical records. In the latter case, Cignet Health was fined $4.3 million for denying patients access to their medical records. And HHS fined Massachusetts General $1 million for the loss of 192 patients’ PHI.
It’s clear that OCR is ready and willing to impose penalties for violators. And there have been several violations to date, mostly related to improper disclosure of PHI—with 14,000 reported privacy incidents, the majority due to theft and loss, according to the OCR website. Technology has complicated matters, with laptops and other portable storage devices such as USB flash drives accounting for 38 percent of reported incidents.
-----

Groups praise new Calif. telehealth law

Posted: October 11, 2011 - 11:30 am ET
The California Telemedicine and eHealth Center, Sacramento, praised California Gov. Jerry Brown's signing of the Telehealth Advancement Act of 2011 (PDF).
The act, signed Oct. 7 by Brown, loosens requirements about who can provide care using telehealth—expanding eligibility to all licensed healthcare professionals—and makes it easier to provide such care through the state's Medicaid program and under certain circumstances for patients who have private insurance. Hospital credentialing for telehealth also was made easier, according to a CTEC news release. The law drops the term "telemedicine" in favor of "telehealth."
-----

Blue Button use blows away VA expectations

Posted: October 11, 2011 - 12:00 pm ET
More than 430,000 veterans have downloaded their healthcare claims information through the U.S. Veterans Affairs Department's Blue Button initiative—far exceeding initial predictions for use of the service.
The results to date for the technology, which aims to make it easy for VA patients to go online and download copies of their medical records, were reported Tuesday by Todd Park, chief technology officer at HHS, during the FedTalks 2011 conference in Washington.
-----

Healthcare's Missing a Big (Data) Opportunity

Gienna Shaw, for HealthLeaders Media , October 11, 2011

Cleveland Clinic's top 10 medical innovations for 2012, released at the annual Medical Innovation Summit last week, included a mix of cool medical devices, new treatment protocols and procedures, and other healthcare technologies that, according to the organization, have significant potential for short-term clinical impact and a high probability of success.
The list includes wearable robotic devices, genetically modified mosquitoes, and medical apps for mobile devices—and one item that's not quite like the others: Harnessing big data to improve healthcare.
"Healthcare data requires advanced technologies to efficiently process it in reasonable time, so organizations can create, collect, search, and share data, while still ensuring privacy," the organization said in a release. "In this way, analytics can be applied to better hospital operations and tracking outcomes for clinical and surgical procedures. It can also be used to benchmark effectiveness-to-cost models."
-----

Adastra is up in the cloud

11 October 2011   Shanna Crispin
NHS Ayrshire and Arran has become the first provider to run the Adastra patient management service through the cloud.
The Scottish health board’s Ayrshire Doctors on Call out-of-hours service has migrated to the cloud-based implementation of the Adastra system from Advanced Health and Care.
The board made the decision when it was faced with a temporary office move because of building refurbishments.
-----
Tuesday, October 11, 2011

The Next Five Years in Health IT: ONC's Plan for the Future

On Sept. 12, the Office of the National Coordinator for Health IT released an updated strategic plan for implementing a nationwide health information network. The Federal Health IT Strategic Plan 2011-2015 sets forth activities to improve health care through use of health IT tools.
Below is an overview of the Strategic Plan and some of the federal government's newest initiatives, including the Query Health initiative, the electronic health record data segmentation initiative and various initiatives to drive consumer engagement in health care, such as the recent proposed regulation affording individuals direct access to laboratory results.
-----

Kaiser Permanente Leads the Nation in 11 Effectiveness of Care Measures

OAKLAND, Calif., Oct. 10, 2011 /PRNewswire/ -- Kaiser Permanente leads the nation with the most No. 1s receiving top marks in 11 out of 40 effectiveness of care measures among all reporting commercial health plans. These conclusions were based on information in the 2011 National Committee for Quality Assurance's Quality Compass® data.
-----

Electronic patient records are always on next year's agenda

The Patient from hell is impressed by the honesty on show at a hospital trust's AGM, but finds digitised records permanently stuck in any other business
Monday 10 October 2011 09.00 BST
Last week, I did something I have never done before: I attended the annual general meeting of one of the nearby hospital trusts. There were no fireworks. The trust is working towards foundation status and hitting its financial targets. It has about the best maternity unit in the south of England. Judging from my own visits over the last few years, it is definitely more patient-friendly than it was.
So, I was encouraged that the chief executive felt able to admit where things had gone wrong, as hospital administrators seldom do. For instance, the 18 week gap between diagnosis and treatment had slipped. She admitted that this was down to administrative error and promised to get back up to date by the end of this month. I liked her honesty.
She also apologised that some consultants took a month to write discharge summaries for their patients. I had understood that the Department of Health decreed about two years ago that discharge summaries must arrive at the patients' GPs within 48 hours of discharge. This shows that some senior doctors are still happy to flout DH instructions and the obvious well-being of their patients, despite the admonishments of a tough chief executive. I suppose I should not be surprised by this. Twas ever thus, and probably ever will be.
-----

Consensus on digital certificates should boost Direct Project messaging

October 4, 2011 — 4:45pm ET | By Ken Terry
The Direct Project, the secure clinical messaging protocol introduced earlier this year, has advanced to the next level with the announcement that a workgroup of the Direct Project consortium has reached agreement on a key component of the "trust framework" that will be required for Direct messaging.
The Direct Project Rules of the Road workgroup has formulated a certificate policy that will govern the use of digital certificates when providers exchange messages. These will be used to authenticate the identities of senders and receivers.
-----

Health IT key to HealthAmerica medical home pilot

October 8, 2011 — 9:55am ET | By Ken Terry
Preferred Primary Care Physicians, a 32-doctor group in the Pittsburgh area, is piloting an advanced medical home model with assistance from HealthAmerica, a subsidiary of Coventry Health Care. Health IT will be a crucial component of the medical home project, in which personal physicians will coordinate patients' care across care settings.
"Our electronic health record and our robust data mining capabilities will be crucial in supporting optimal patient care, performance measurement, patient education, and communication," Gregory Erhard, executive director of Preferred Primary Care Physicians, said in a announcement.
-----

Human-computer interface progress vital to success of EHRs

October 9, 2011 — 7:38pm ET | By Ken Terry
Steve Jobs' passing last week has triggered myriad reflections on his immense contribution to the modern world. While much emphasis has been placed on Apple's recent trendsetting products--the iPod, iPhone and iPad--the signal contribution of Apple under the leadership of Jobs and Steve Wozniak was to make the personal computer practical and useful. Beyond the Apple operating system itself, the invention of the Macintosh computer--which used a mouse-based graphical user interface derived from an experimental Xerox product--radically redefined the relationship between humans and computers.
Despite all the technological advances since then, however, physicians continue to struggle with that relationship. I recall that back in the 1990s, when I began covering this space, there was considerable disagreement among experts about whether electronic medical records were ready for prime time. Clement McDonald, MD, who helped pioneer health IT at Indianapolis' Regenstrief Institute, once told me that doctors would never accept EMRs (now known as EHRs) until they could dictate their notes and have them transcribed automatically into discrete data.
-----

Information Governance and Analytic Asset Management

By Mark Vreeland, Executive Director, Advisory – Health Care, Ernst & Young LLP
HDM Breaking News, October 6, 2011
In an earlier article for Health Data Management, I defined the three main disciplines of a sound information governance model for health care organizations.
Together, those disciplines – the business information, systems and network, and information asset– support the entire lifecycle at a health care organization.
I now want to take a closer look at a health care organization's most important information assets:  its analytic assets.
-----

Public health and HIE: MPI synchronization

October 07, 2011 | Noam Arzt, PhD, FHIMSS
One of the key elements of an HIE is the Master Patient Index (MPI), which associates records from multiple sources accurately with a single patient. Various software techniques are available to ensure accurate matching to prevent erroneous association of data from different patients (false “positive”), or failure to associate data from the same patient together (false “negative”). Deterministic tools are rules-based; probabilistic tools rely on mathematical algorithms and constructs. In either case, there is usually some manual intervention necessary to resolve ambiguous record matches where the automated algorithms cannot establish a match (or non-match) with sufficient certainty. An additional issue that HIEs face is deciding exactly who should be responsible for this activity: central HIE administrative staff, staff from participating organizations (particularly hospitals who provide larger sets of records), or both.
-----

12 Elements to Support a Viable Health IT and Telehealth Infrastructure

Written by Bob Herman | October 07, 2011
Health information technology has essentially become a requirement for all niches of healthcare — rural, urban, state, local, federal and everything in between — and it's evident that a strong health IT infrastructure will help providers transition into the new era of stronger quality care.
The Oregon Health Network is one example of an organization that is trying to assist local providers in health IT implementation, especially within the telehealth realm. OHN received a subsidy of more than $20 million through the Federal Communications Commission's Rural Health Care Pilot Program, and it aims to improve the disparity and quality of care for Oregon's geographically and economically diverse population through telehealth promotion. Kim Lamb, executive director of OHN, says hospitals and other providers are going to be instrumental in keeping these types of health IT infrastructures strong, and for hospitals' communities to thrive in the dawn of telehealth, there are 12 key elements providers of all types and sizes, including hospitals, must address to experience the full benefits of strong health IT.
-----

Cellphone monitors vital signs

Posted on October 7, 2011 - 06:08 by Kate Taylor
A researcher has developed a heart monitoring smartphone app that he says is as accurate as standard medical monitors now in clinical use.
Building on the idea of using a smartphone to measure heart rate, and has added other medical monitoring facilities, Worcester Polytechnic Institute (WPI) professor Ki Chon has developed an application that can also measure heart rhythm, respiration rate and blood oxygen saturation using the phone’s built-in video camera.
"This gives a patient the ability to carry an accurate physiological monitor anywhere, without additional hardware beyond what’s already included in many consumer mobile phones," he says.
-----

Smartphones, medical apps used by 80 percent of docs

October 06, 2011 | Molly Merrill, Associate Editor
ALPHARETTA, GA – Four out of five practicing physicians use smartphones, computer tablets, various mobile devices and numerous apps in their medical practice, according to a new report from Jackson & Coker.
“Tech-savvy physicians, especially recent graduates, increasingly rely on digital and Internet-based tools to communicate with patients and improve the medical outcomes of the care they provide,” said Sandra Garrett, president of Jackson & Coker.
The report, titled “Apps, Doctors and Digital Devices,” presented the results of several recent studies that investigated the use of smartphones, mobile computing devices and a wide variety of software apps by physicians in different specialties.
-----

Will IT And Clinicians Ever Get Along?

Cultural differences are partly to blame; experts offer ideas to bridge the chasm.
By Paul Cerrato,  InformationWeek
October 07, 2011
The truism "Culture eats technology for lunch" surfaced during a recent InformationWeek Healthcare Webcast. Jared Quoyeser, director of healthcare marketing at Intel, one of the Webcast's sponsors, mentioned it during his presentation on mobile devices, and it reminded me of a similar maxim: "Policy changes from funeral to funeral."
The point here is no matter how useful a new healthcare technology is, whether it be a mobile device or an electronic health record (EHR), it's not going to take hold unless it fits in with the mindset of clinicians. And that mindset can sometimes be inflexible.
-----

Medical Imaging Gets Free Ride In the Cloud

Dell, Merge Healthcare partnership gives clinicians free access to the software vendor's image sharing system, also adds flexibility for selling add-on services.
By Neil Versel,  InformationWeek
October 07, 2011
Medical imaging software developer Merge Healthcare has introduced free access to a cloud-based image-sharing network. The company has partnered with Dell, which already manages more than 4 billion medical images and related studies, announced Chicago-based Merge at its annual users' conference this week.
Merge said that the imaging cloud, dubbed Merge Honeycomb, will be the nation's largest network for sharing medical images. Honeycomb, which the vendor will formally launch at the Radiological Society of North America (RSNA) annual meeting in November, will be open to all healthcare organizations, regardless of whether they are Merge customers.

-----
Enjoy!
David.

Friday, October 21, 2011

We Really Need To Make Sure Clinical Guidelines Are Uncontaminated by Conflict of Interest. It May Not Be All That Easy!

The use of clinical decision support to assist in the practice of evidence based care is fundamental to the benefits case for deployment of e-Health at the level of the individual clinician. From both Australia and the US in the last week or so there have been some worrying reports emerge.
First from the US we have:
  • October 12, 2011, 2:24 PM ET

Guideline Experts Have Conflicts of Interest, Study Finds

Ever wonder who’s behind the new recommendations for, say, how to treat high cholesterol or whether to screen men for prostate cancer? More specifically, do you ever wonder whether experts on the panels that develop guidelines have financial ties to pharma or device companies that might be affected?
The Institute of Medicine recommends that ideally, guideline developers shouldn’t have any financial investments in companies that stand to benefit from recommendations, nor should they (or family members) participate in marketing activities or advisory boards of those companies.
Sometimes it’s not possible to convene an entirely conflict-free panel, in which case members with financial ties to industry should be only a minority of the panel, the IOM says. Panel chairs or co-chairs should not have conflicts at all, and industry shouldn’t have a role in developing the guidelines, the group says.
Using that framework, researchers looked at 14 guidelines published by groups in the U.S. and Canada for screening or treatment of high cholesterol and diabetes. Of the 288 total panel members, 52% had conflicts of interest — 138 declared, and 12 undeclared. (Some of those were undeclared because the panels were among the five that didn’t require public disclosure.)
Conflicts were more likely on panels sponsored by non-governmental groups, the study found. The findings appear in BMJ.
More is found here:
And from Australia we have the following editorial in the Medical Journal of Australia this week.

Annette Katelaris: Guidelines conundrum

IT IS hard to imagine that clinical guidelines, in their current incarnation, will survive.
Undoubtedly, doctors need high-quality information to guide clinical decisions, but the development and implementation of clinical guidelines is fraught with difficulty.
We have seen heated debate on this subject in the MJA, and two more articles in the latest issue add fuel to the fire. In one article, Michael Williams and colleagues make a strong demand for the “Comprehensive disclosure of conflicts [of interest] … to safeguard the integrity of clinical guidelines and the medical profession”.
As they observe, and we know, compliance with guidelines is equated to delivery of high-quality care, and can affect doctors’ remuneration. Guidelines themselves, then, must be beyond reproach.
Yet, according to Williams et al, only 15% of the 470-plus guidelines on the NHMRC portal contain a conflict of interest statement — a longstanding requirement for research papers. This is surprising, as guidelines have much more influence on clinical practice than a single research paper.
A 2009 Institute of Medicine report (Conflict of interest in medical research, education and practice) outlined several examples of inappropriate industry influence on clinical guidelines development in the US.
More here:
There is also some additional commentary here:

Guidelines — “valuable and vulnerable”

CLINICAL practice guidelines are vulnerable to bias, with only 15% of NHMRC guidelines from Australia’s most prolific guideline developers including a declaration of conflicts of interest, new research has found.
Although a conflict of interest (COI) statement has long been required from authors of research papers, it is often lacking for developers of clinical practice guidelines, despite the influence of guidelines on clinical care.
The research, in the latest issue of the MJA, looked at more than 200 clinical guidelines that were listed on the NHMRC website. Its authors concluded that the NHMRC needed to “urgently promote a more ethically sound development process for guidelines”. (1)
“Guidelines are valuable and vulnerable”, the authors, led by Michael Williams, a researcher from the Michael Kirby Centre for Public Health and Human Rights at Monash University, wrote.
“Our review of the country’s most prolific guideline developers shows that only 15% of guidelines have COI statements”, they said.
“This raises questions about whether medical bodies are affected by unrecognised, and thus unaddressed, extraneous interests, and may erode the trust the community has in the profession to speak authoritatively about health problems.”
The authors said individuals, institutions and professional bodies could have COIs, with the most common being financial links to industry, such as being paid consultancy fees or honoraria, or holding company shares.
More here:
We also had this article appear where concern is being expressed at a public level.

Drug companies pay doctors to spruik products

DRUG companies are paying specialists up to $1500 to sell the benefits of new products to their peers, a former saleswoman has revealed, raising questions about the independence of the medical profession.
Petra Helesic says many specialists ask drug companies to pay business class airfares for their trips to international medical conferences and cover their bills at five-star hotels.
Sales representatives can earn bonuses of up to $8000 a year if they can increase prescription numbers above certain targets, documents Ms Helesic has provided to The Australian show.
More here:
This is really pretty serious stuff, as there is something about using e-Health to re-enforce clinical practice which is distorted by conflict of interest or other forces.
The recommendation for full disclosure of the funds received by guideline formulators seems more than reasonable, as would the idea that all guidelines be peer reviewed by independent clinicians with no potential conflicts - remembering, of course, that, as drug company funds are the life blood of support for many research projects and the associated academic careers a flat out ban really is not practical.
What is needed is full disclosure, independent peer review and careful use of guidelines that may be over influenced by ‘big pharma’. This will always be a balancing act but we need to be careful!
David.

Thursday, October 20, 2011

Final Submission on Draft Legislation for the PCEHR. It Is Just Pathetic I Believe!

Submission to the Commonwealth Department of Health and Ageing.

Topic: Exposure Draft PCEHR Bill

Date October, 2011
Submissions Due: 28 October, 2011
Address for submissions:
E-mail:
Postal Mail:
PCEHR Legislation Issues Feedback
Department of Health and Ageing
GPO Box 9848
Canberra, ACT 2606
Submission Author:
Dr David G More BSc, MB, BS, PhD, FANZCA, FCICM, FACHI.
Author Contact Details:
Phone +61-2-9438-2851 Fax +61-2-9906-7038
Skype Username : davidgmore
E-mail: davidgm@optusnet.com.au
HealthIT Blog - www.aushealthit.blogspot.com
Twitter @davidmore
Author’s Background. I am experienced specialist clinician who has been working in the field of e-Health for over 20 years. I have undertaken major consulting and advisory work for many private and public sector organisations including both DoHA and NEHTA.
Previous Submissions
I previously provided a Submission on the PCEHR proposal to NHHRC in May, 2009 and the views expressed in that submission remain my position despite the work undertaken by DoHA and NEHTA since.
This submission is available here:
A later submission on the Draft Concept of Operations for the PCEHR from May2011 is found here:
Consent for Publication.
I am more than happy for this submission to be made available for public review on the Department of Health and Ageing website.

Submission

As a non-lawyer I am unable to comment on the drafting of the planned Bills but am basing my comments on the Companion to the Exposure Draft Bill - as I am sure this document accurately reflects both the intention and the drafting of the proposed Bill(s).
It is my view that the intent reflected in the Companion document is deeply flawed and will result in failure of the PCEHR System to deliver the outcomes sought by the Government.
In my view there are two major errors of omission and two major errors of commission contained in the present proposals.
Error of Omission Number 1. - The Lack of an Agreed, Consulted and Legislated Framework for the Governance of the PCEHR.
On Page 13 of the Companion: (as reported by Adobe Reader)
"It is intended that the Secretary will fill the role of System Operator initially. Further discussions will be held with the states and territories around possible future options for the long-term governance of national e-health such as an inter-jurisdictional body."
This is a disastrous flaw and will guarantee there is simply no one will trust the system. Having a system holding your private health information which is not at arm’s length to Government and to political interference is vital.
I believe the best way this can be achieved is via an independent Statutory Authority which is responsible to parliament for its activities, reports regularly, is subject to review by Parliament and Senate Estimates, has a formal recurring budget allocation and a properly constituted and accountable board.
Unless this is planned, discussed, legislated and delivered the Government is simply setting itself up for a lack of public confidence and failure.
Error of Omission Number 2. The Failure to Provide a Legislated and Obligatory Breach Reporting Regime.
On page 29 of the Companion to the Exposure Draft we read:
“Certain participants in the PCEHR system must notify certain matters such as data breaches or risk of being in contravention of the Draft Bill with potential civil penalties to apply to those contraventions.
Entities such as the System Operator, a registered repository or registered portal provider have obligations to report matters to the System Operator, or in certain circumstances both the System Operator and the Information Commissioner.
In addition to the notification, the entity must do the followings things:
  • contain the contravention and undertake a preliminary analysis;
  • evaluate the associated risks;
  • if the entity is the System Operator – consider notifying the affected consumers;
  •  if the entity is not the System Operator – ask the System Operator to consider notifying the affected consumers.
In addition, the entity must take steps to prevent or mitigate the effects of further contraventions, events or circumstances in relation to the unauthorised collection, use or disclosure of health information included in a person’s PCEHR.
A further civil penalty provision in the Draft Bill provides that a registered repository operator or a registered portal operator must not contravene the PCEHR Rules that apply to that operator or portal.”
Can I suggest this is just not good enough. The legislation should make it clear that the release or breach of any personally identifiable information should be notified to the individual concerned and additionally any breach that involves more than 100 individuals should be notified to the public with an analysis of what caused the breach.
Of course notification is just bolting the door after the horse has gone and clearly the legislation should also make it clear, as it does to some extent, that to prevent breaches in the first place is required and to not take reasonable preventative steps is also an offence.
Proof of the benefit of this approach is that in the US there is compulsion to notify significant breaches and, of course, this is the reason we know how it bad it is over there and why we need the same approach here.
Error of Commission Number 1. A blatant attempt to transfer responsibility for identification of users of the PCEHR from the Government provided security systems to the practitioner or other entity who is accessing the PCEHR .
Page 33 of the Companion: (As reported by Adobe Reader)
“Registered healthcare provider organisations must ensure that individuals accessing PCEHRs on their behalf (i.e. authorised users) provide, at the time of access, sufficient information to identify the individual accessing the PCEHR. This requirement is essential to ensuring a comprehensive audit trail is maintained of access to consumers’ PCEHRs.”
What does this actually mean and how will it work? It seems to it mean the provider organisation needs to retain an audit trail of which user who logged on to what system using the organisational certificate. Note this appears to transfer an obligation to do so from the PCEHR Operator and the PCEHR system back to the healthcare provider organisation.
It is also clear that the approach to providing a user specific audit trail from provider to the PCEHR system is still pretty much a work in progress (in the absence of NASH actually being defined and implemented) - and that the assurances given by NEHTA and the Minister that full audit trails of user access will not be available when the System commences - and for a good while thereafter if special legislative cover is required.
No provider is going to expose themselves to the substantial penalties proposed for no benefit. This approach will ensure just zero practitioner participation once they are advised of the risks by their indemnity insurers.
Error of Commission Number 2. Removal of Both The Commonwealth and All Jurisdiction from Any Accountability and Liability for Harm and Damage Caused by The PCEHR System.
Page 8 of the Companion: (As reported by Adobe Reader)
“Binding of the Crown
The Draft Bill applies to the Commonwealth, states and territories and section 7 of the Draft Bill provides that all jurisdictions will be subject to this law.
While each jurisdiction will be legally bound by the arrangements set out in the Draft Bill, the Crown in right of the Commonwealth, states and territories will not be subject to prosecution and will not be liable for pecuniary penalties.”
So it seems no Government can be sued or prosecuted for any harm or damage resulting from this Legislation and its implementation.
This section clearly does not correctly balance the interests of citizens and government.
There are a number of other minor points where I feel the planned Legislation is in error but correcting the issues cited above would clearly take enormous strides towards some satisfactory and implementable outcomes.

Summary:

The legislation, as proposed, is inadequate and simply not credible. Health care providers will find the legislation overall quite onerous and offensive and consumers will quickly discover their interests are not properly protected.
The lack of a really secure and legislated governance framework is simply absurd and reflects the fact that the Government does not understand what is required in the management of the e-Health domain.
I am more than happy to discuss these views with any Departmental Officer who understands what is at stake.
David G. More
Date 20.10.2011.