The US Releases a New Health IT Strategic Plan. Well Worth A Browse.

Here is the US Government Blog Post announcing the revised plan.

http://www.healthit.gov/buzz-blog/from-the-onc-desk/release-federal-health-strategic-plan/

Release of the Federal Health IT Strategic Plan 2011 – 2015

September 12, 2011, 11:39 am

Jodi G. Daniel / JD MPH Director of the Office of Policy and Planning , and Seth Pazinski

Today, the Office of the National Coordinator for Health Information Technology (ONC) published the Federal Health IT Strategic Plan 2011 – 2015 (the Plan). The Plan, and our strategy, benefited from the valuable input we received on the draft Plan that was out for public comment from March 25 – May 6, 2011. The 240 responses to our blog post requesting public feedback on the draft helped us to refine and solidify the final Plan.

This by no means marks the end of our strategic planning. The Plan is meant to be a living document that will be updated based on experience with stage one of the meaningful use electronic health record (EHR) incentive programs and the results of our evaluation program. We will continue to track national progress toward achieving the goals laid out in this Plan, particularly the high-priority goal for providers to adopt and become meaningful users of certified EHR technology. Based on this new knowledge, we’ll begin another open process to revisit and update our strategy and this Plan. As always, our planning efforts will be done in coordination with our Federal partners and with insights from private stakeholders and the general public.

We’d like to thank everyone who provided feedback on the draft Plan. Below are highlights of the themes that emerged from the comments and some ways in which feedback has been incorporated into the Plan itself.

Privacy Comments, Particularly Around Consent Management

The privacy and security of identifiable health information should be protected wherever it is electronically transmitted, maintained, or received. While the HIPAA Privacy and Security Rules are key safeguards, they are not the only means available for affording this protection.

HHS has commenced the process of exploring broader privacy and security policies that may be necessary to ensure trust in electronic health information exchange. This process is being guided by the Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information, a set of privacy and security principles grounded in the fair information practices released in 2008. HHS has commissioned a principal-level, inter-division workgroup to develop an updated approach to privacy and security policies. The efforts of this workgroup are informed by the recommendations of ONC’s federal advisory committees – the HIT Policy Committee and HIT Standards Committee – on privacy and security issues. Broader Federal participation in developing privacy and security policies is obtained through the Federal Health IT Taskforce. One of the major areas being addressed through this process is pursuing policy changes that would afford individuals more meaningful choice as to whether their information may be exchanged electronically. ONC is also assessing technical solutions that could support more granular patient choice and data segmentation that could support a patient’s choice to share only certain parts of their record during information exchange.

Comments about the Pace of Change and Timing for Stage 2 Meaningful Use

We fully acknowledge the Plan is ambitious, but wholeheartedly believe that meaningful use of certified EHR technology provides the electronic infrastructure that is essential to support implementation of key delivery system transformations, like Accountable Care Organizations and Patient-Centered Medical Homes, and the priorities in the National Quality Strategy.

As was mentioned at the July 6, 2011 HIT Policy Committee meeting, we appreciate the dedicated members of the HIT Policy Committee who gathered expert testimony and considerable stakeholder input from both providers and vendors, and put in long hours reviewing and analyzing the pros, cons, and consequences of changing the timing for the start of stage 2 of the Medicare and Medicaid EHR Incentive Programs. In the end, the HIT Policy Committee recommended Stage 1 be extended by a year just for those attesting in 2011 in order to incentivize early adoption and meaning use of EHRs. This approach would allow extra time to help providers and vendors develop more comprehensive EHR functionality, avoid disincentivizing early adoption, and it would mean that all providers first attesting to meaningful use in 2011 or 2012 would have until 2014 to move up the escalator to stage 2.  Moreover, at this meeting, we expressed support for this recommendation and indicated that we have passed this along to our colleagues at the Centers for Medicare & Medicaid Services (CMS) to consider as they develop the notice of proposed rulemaking for meaningful use Stage 2.

Comments about the Usability of EHR Products

Improved usability of EHR products is an important goal that can lead to increased adoption and effective use of EHRs to deliver safer and better quality care. In order to improve the usability of EHRs, we will support National Institute of Standards and Technology (NIST) and research to refine EHR usability testing and use protocols targeted at improving safety and efficiency.  This work will occur in a transparent process, engaging EHR developers, researchers, and other stakeholders.  We will also work on greater transparency and better guidance for EHR users and purchasers with regard to EHR usability.

ONC intends to explore ways to improve the ability of providers to change EHR products to better support their needs by improving data portability. Reducing the cost associated with switching EHR products while increasing data fluidity and choice can help drive market competition to improve the usability of EHR products.

Request for More Information on Outreach and Education to Providers and Consumers
In order to achieve the highest participation possible in the Medicare and Medicaid EHR Incentive Programs, ONC and CMS are working together on a coordinated outreach and education campaign directed at providers and hospitals. Our approach is two-pronged and involves distributing critical information and materials nationally, while focusing on local communities to engage audiences where they live and work.  We’ve already started collaborating with stakeholders and the media to distribute materials and established a strong online presence through social media.

In addition, ONC and the Office for Civil Rights are gearing up to launch a national campaign this month, designed to increase consumers’ awareness about:

• The transition to health IT;
• How to access their health information;
• The benefits of leveraging health IT tools to better manage their health; and
• Privacy rights to access and protect their health information.

The campaign slogan, Putting the I in Health IT^SM, provides a platform for patients and providers to share their personal stories using health IT to improve care.  As part of the campaign, ONC launched a new website for patients and providers, HealthIT.gov.  An integral part of the campaign is a continuous feedback loop where we will learn from experience and make necessary adjustments along the way.  Some campaign materials will be available in multiple languages.

Other Comments

The themes highlighted above are only a subset of the comments we received, which, like the Plan, cover a wide range of topics. Some additional areas that we heard a lot of feedback on, and led to revisions in the Plan, include:

• Barriers to adoption and health information exchange
• Support for further harmonization of standards
• Support for the inclusion of providers not eligible for incentive payments under the Medicare and Medicaid EHR Incentive Programs in information exchange for purposes of care coordination
• Need to address accessibility
• Concern that the private sector was not engaged in learning  about efforts of the health care system

Thank you again for your insights. We appreciate your support and candor, and we welcome your challenge to create a Plan that will achieve the ambitious goal of modernizing the health care system and ushering in a new era of electronic health information. The revised Plan is available on our website at: http://healthit.hhs.gov/strategicplan.

There is a report here:

HHS releases final Health IT Strategic plan for 2011-15

By Joseph Conn

Posted: September 12, 2011 - 6:00 pm ET

Tags: Information Technology, Office of the National Coordinator for Health IT (ONC), Patient privacy, Policy

The Office of the National Coordinator for Health Information Technology at HHS has released an 80-page final version of its Federal Health Information Technology Strategic Plan for 2011-2015.

The latest version replaces a draft put up for public comment in March.

One new wrinkle in the final document comes under the third of five major policy goals, to "Inspire Confidence and Trust in Health IT" by "protecting the privacy and security of healthcare information and ensuring the safe use of health technology."

The plan calls for an elaborate process involving entities outside of HHS and its Office for Civil Rights to "resolve federal policy direction" on a "first set of privacy and security issues by the end of 2011." The civil rights office oversees privacy and security enforcement under the Health Insurance Portability and Accountability Act of 1996 and has been the lead agency in drafting federal healthcare IT privacy and security rules.

To help with the policy work, the latest IT strategic plan calls for the creation of an "HHS Inter-Division Task Force" that will be charged with establishing policy direction.

More here:

http://www.modernhealthcare.com/article/20110912/NEWS/110919993/hhs-releases-final-health-it-strategic-plan-for-2011-15

Also there is a report here:

4 facets of ONC's strategic plan shaped by public comments

September 12, 2011 | Tom Sullivan, Editor

WASHINGTON – The Office of the National Coordinator for Health IT on Monday published its Federal Health IT Strategic Plan 2011-2015. ONC’s final version comes after a hearty public comments period, in which the agency received some 240 responses to its draft, some of which ONC claimed were incorporated into the plan.

ONC explained on its HealthITBuzz blog that woven in the comments were four key themes. Here are those, and how the office used them to sculpt its plan.

1. Privacy: With an eye on electronic health information exchange, the Department of Health and Human Services (HHS) established a “principal-level, inter-division workgroup to develop an updated approach to privacy and security policies." The workgroup, ONC explained, will work with the HIT Policy Committee and HIT Standards Committee and the Federal Health IT Taskforce on issues including patient consent to data sharing.

2. Timing of Stage 2 meaningful use: Describing the meaningful use of certified EHRs as the electronic infrastructure to enable health systems transformations such as accountable care organizations and patient-centered medical homes, ONC carried forth its recommendation that CMS extend Stage 2 of meaningful use until 2014.

More here:

http://www.govhealthit.com/news/4-facets-oncs-strategic-plan-shaped-public-comments?topic=08,12,34,18

and lastly here:

Privacy, EHR Policy Changes Coming in Federal Health I.T. Plan

Joseph Goedert

HDM Breaking News, September 13, 2011

More changes to health information privacy rules, and a stronger push for electronic health records interoperability, could be forthcoming under the final Federal Health I.T. Strategic Plan for the next five years from Health and Human Services' Office of the National Coordinator for Health Information Technology.

ONC released a draft plan for comment in May. While the final plan is out, the agency stresses it a "living document" that will be updated as warranted.

Under the final plan, HHS has begun a process of exploring broader privacy and security policies that may be necessary to ensure trust in health information exchange. "One of the major areas being addressed through this process is pursing policy changes that would afford individuals more meaningful choice as to whether their information may be exchanged electronically," according to the plan. "ONC is also assessing technical solutions that could support more granular patient choice and data segmentation that could support a patient's choice to share only certain parts of their record during information exchange."

HHS in the plan reaffirms support for research at the National Institute of Standards and Technology to refine usability testing for electronic health records. The tests would use protocols targeting improved safety and efficiency. "This work will occur in a transparent process, engaging EHR developers, researchers and other stakeholders," according to the strategic plan. "We will also work on greater transparency and better guidance for EHR users and purchasers with regard to EHR usability."

More here:

http://www.healthdatamanagement.com/news/privacy-ehr-onc-strategic-plan-43175-1.html

I have to say that the focus on investment in getting proper effective use of EHRs by health care providers makes a great deal more sense than the nonsense we seem to be pursing - but that is just me I suppose.

The full plan is more than worth a browse!

David.

Well That Seems To Be An End ToThe UK National Health IT Program. There Are Lessons Here I Am Sure!

The following appeared overnight.

NHS told to abandon delayed IT project

£12.7bn computer scheme to create patient record system is to be scrapped after years of delays

The Guardian, Thu 22 Sep 2011 01.54 BST

An ambitious multibillion pound programme to create a computerised patient record system across the entire NHS is being scrapped, ministers have decided.

The £12.7bn National Programme for IT is being ended after years of delays, technical difficulties, contractual disputes and rising costs.

Health secretary Andrew Lansley, Cabinet Office minister Francis Maude and NHS chief executive Sir David Nicholson have decided it is better to discontinue the programme rather than put even more money into it. The axe may be wielded , with ministers likely to criticise the last Labour government for initiating the project but doing too little to ensure it delivered its objectives.

An announcement has been expected for months after the National Audit Office cast serious doubt on the wisdom of ploughing further money into the scheme and David Cameron told MPs in May that he was considering that advice. Whitehall sources confirmed the decision had been made because of coalition cost-cutting and the ongoing problems.

"It was meant to be a very helpful thing for NHS staff and patients but instead has become this amazingly top-heavy, hideously expensive programme. The problem is, it didn't deliver", said a Department of Health source.

More here:

http://www.guardian.co.uk/society/2011/sep/22/nhs-it-project-abandoned

There are clearly a lot of lessons to be learnt. I hope we bother to look very closely as what happened and exactly why!

David.

Patient Access To Health Information. What Are Some Of The Issues?

There are some interesting moves happening in the US with regard to the access, by patients, of their laboratory test data.

This is reported here:

New Rule: Individuals Can Get Test Results from Labs

Joseph Goedert

HDM Breaking News, September 13, 2011

The Department of Health and Human Services has issued a proposed rule enabling patients to electronically access their laboratory test result reports directly from labs.

The rule, available here on Sept. 13 and being published Sept. 14 in the Federal Register with a 60-day comment period, affects labs that are covered entities under HIPAA. The rule amends the Clinical Laboratory Improvement Amendments of 1988 that exempted labs from provisions that give patients the right to access their protected health information.

The rule specifies that "upon a patient's request, the laboratory may provide access to completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient," the proposed rule states.

More here:

http://www.healthdatamanagement.com/news/hhs-patients-labs-disclosure-rule-43171-1.html

There is commentary here:

Caveats Abound on Patient Access

Greg Gillespie

Health Data Management Blogs, September 15, 2011

The recent proposal from CMS to allow patients electronic access to test results via laboratories is another step in the inexorable march toward information transparency.  The agency is also trying to expand patient access rights to data disclosures (though the jury’s still out there) and has consistently chipped away at the long-standing tenet that medical data should stay in the hands of medical practitioners.

Patients should have full rights to the data generated and used to understand their health condition and develop treatments in response. But lifting the veil, while seemingly inevitable, is just as inevitably going to cause confusion and rachet up the tension between medical practitioners and those they serve.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) that a new proposed rule would amend currently limits  the disclosure of laboratory test results to three categories of individuals: the ‘‘authorized person,’’ the person responsible for using the test results in the treatment context, and, in the case of reference laboratories, the referring lab. “Authorized person” is defined in as the individual authorized under state law to order or receive test results, or both. In states that do not provide for individual access to the individual’s test results, the individual must receive his or her results through the ordering provider.

 The proposed rule states that “While individuals can obtain test results through the ordering provider, we believe that the advent of certain health reform concepts (for example, individualized medicine and an individual’s active involvement in his or her own health care) would be best served by revisiting the CLIA limitations on the disclosure of laboratory test results.”

The issues with test results, as with any other data distribution, are context and interpretation. We’ve reported frequently on the development of personal health records, and a huge sticking point faced by patient-facing PHRs is providing meaningful information and context to those who don’t understand the languages spoken in health care. How many patients can interpret claims data and derive any insights from diagnosis codes and test results without plain English (or other languages, but that’s another point in an increasingly multi-linguistic society) explanations of what they mean. There’s value, and more value is being added as PHRs become more sophisticated, but without a medical editor, misinterpretation occurs pretty easily.

The dangers of misinterpretations are magnified in the arena of unfettered access to lab results. Providers are the current middleman in this data exchange, and they take pains to build context into results reporting, even if they’re doing it in an automated fashion.

Lots more here:

http://www.healthdatamanagement.com/blogs/CMS_rule_test_results_patient_access-43182-1.html

and here:

On lab results, it's "Show me—first"

By Joseph Conn

The CMS this week published what it described as a proposed rule that I'm calling the "Me First" Lab Rule.

Today, patients can obtain their laboratory test results from their healthcare providers under guarantees in the Heath Insurance Portability and Accountability Act of 1996. In a few more years, the CMS' own electronic health-record incentive programs should spur widespread provider adoption of interoperable EHRs, and that should speed up patient access to lab results considerably. By then, the torrent of an estimated 6.1 billion test results per year will pour automatically into those provider EHRs. From there, lab results should flow automatically to patients by way of personal health record systems "tethered" to providers' EHRs.

The CMS' proposed rule, however, reinterprets both the flow-controlling Clinical Laboratory Improvement Amendments of 1988 and the HIPAA privacy rule in a way that pre-empts many state lab-access laws and procedures. It changes who gets to see test results first, the physician or the patient.

Both CLIA and HIPAA now support a states'-rights approach to test results reporting. They look first to state law, and then, if none is applicable, to federal law. Thus, in 39 states and U.S. territories, lab test results must flow first to the ordering or using provider.

Only nine states have laws that permit a patient to receive test results directly from a lab. Seven states permit direct connections with the provider's permission.

It's a doc-centric system in most states, but one from which patients derive benefits. To give docs their due, sending lab results to them first supports the doc's role as the first interpreter of lab results' clinical meaning, the first counselor of bad news, and the first planner, with the patient, of a course of treatment. The CMS rule-writers didn't mention these important roles or analyze the potential impact the loss of the docs being first in line to receive lab values might have on patients.

More here:

http://www.modernhealthcare.com/article/20110915/BLOGS02/309159999

I raise this issue as I am sure we will wind up having a similar discussion at some point in the future in Australia.

For what it is worth, while recognising the rights of patients to access their information, it seems to me that delivery and explanation of the implications of a test result - or results - should be left to the clinician ordering the investigations.

There are obvious and reasonable exceptions - especially when regular testing is done in the context of tracking chronic illness - where the patient will be as aware as the clinician as to the meaning of such a result - e.g. an INR or a blood sugar in a diabetic.

In this situation I would like to see a standing order (with agreement) be possible where patient access can be automatic for such tests.

That way the informed patient can be as empowered as they wish to be - and the unsuspecting or uninformed can avoid a possibly scary surprise which may have an easy explanation.

Bottom line is that there is a sensible balance here - and the Yanks seem to have gone just a tad too far to me!

David.

Here Is What Patients Want From Electronic Health Records. The PCEHR Is Going Off In the Wrong Direction.

The following very interesting study was reported a few days ago.

Majority back online GP services

12 September 2011   Fiona Barr

A survey of almost 3,000 patients and health professionals has found significant support for online GP services such as repeat prescribing requesting and appointment booking.

Patient.co.uk ran a survey of 1,700 visitors to its website and questioned more than 1,000 clinicians - including more than 500 prescribers - about online functionality in primary care.

Of those questioned, 88% of health professionals were in favour of online repeat prescription ordering and 87% of patients wanted to use such a service.

Meanwhile, 86% of health professionals and 85% of patients supported an online appointment booking system.

The vast majority of patients responding to the survey (91%) also said they would use an online tool that allowed them to identify the side effects of drugs and 90%said they would use an online symptom checker.

Patients also wanted an online tool to make product suggestions for specific conditions (86%) although this was only supported by 60% of clinicians.

Conversely, ordering prescriptions for home delivery received greater support from professionals (91%) than patients (78%).

More here:

http://www.ehi.co.uk/news/primary-care/7156/majority-back-online-gp-services

There is really nothing to be said. The functions patients want most are simply not possible in the context of the PCEHR as reflected in the current version of the Concept of Operations.

If Ms Roxon wants voluntary adoption to happen at anything other than a snail’s pace the answers are staring her in the face!

Here is what NEHTA / DoHA thinks is needed as enhancements:

2.8 Potential enhancements

The National E-Health Strategy proposed that the PCEHR System rollout be undertaken via an incremental approach, with the capabilities of the system being expanded over a four-year implementation period.

Potential enhancements could focus on delivering quality improvements and enhancements based on stakeholder demand and lessons learned from implementation and adoption activities. Candidates for later potential enhancements could include, but are not limited to:

• Enhancements to the registration processes.

• Support for collection of a broader range of health information from healthcare providers, such as:

- Delivery of any optional elements delayed from the first release of the PCEHR System.

- Advance care directives (i.e. storage of the directive itself in the PCEHR System rather than just information about the custodian).

- Pathology requests.

- Diagnostic imaging reports, images and requests.

- Health information from registries.

- Care plans.

- Assessments tools.

- Reports from practice-based diagnostic tools (e.g. electrocardiograms).

- Pharmacy based medicine reviews and medication profiles.

- Extensions to the Shared Health Summary to include fields such as infectious disease status, information about implants, etc.

- Information to support an individual with disabilities.

- Information around palliative care.

• The addition of consumer-oriented features, such as:

- Integration with consumer-oriented personal health records enabling an alternative form of interaction by an individual with their PCEHR.

- Collection of information from consumer devices such as blood pressure monitors, blood glucose monitors, etc.

• Access to information within other sources, such as:

- Screening registers, such as the National Bowel Cancer Screening Register, BreastScreen Australia registries, pap smear registries, etc.

• Addition of new views to the PCEHR System to support the needs of specific groups, such as:

- Views to support management of chronic diseases.

- Views to support individuals and their representatives.

- Views to support specific healthcare providers, such as nurses and allied health providers.

• Enhancements to the template service to support more dynamic and flexible approaches to templating.

• Enhancements to the reporting service to support a wider range of approved uses.

• Enhancements to the PCEHR System access controls.

• Enhancements to support mobile devices.

• Enhancements to facilitate implementation of clinical decision support tools within clinical systems and portals, which leverage information from the PCEHR System.

Initial consultation with a cross-section of stakeholders indicated that some of these features are important to pursue early. However, progress on the above enhancements depends on work being delivered outside the PCEHR Program.

----- End Extract.

Not much in the way of interactivity between clinician and patient there.

This paragraph is quite fun!

“The National E-Health Strategy proposed that the PCEHR System rollout be undertaken via an incremental approach, with the capabilities of the system being expanded over a four-year implementation period.”

First it statement is just untrue and second they again admit - if it can be believed - that 4 years is the implementation period. Make of that what you will.

David.

There Are Real Risks Associated With the PCEHR. Here Are A Few!

Ms Roxon’s intervention in the discussions on the PCEHR made me wonder if there was actually a risk analysis of the PCEHR Program.

See here to read her comments I reported a day or so ago:

http://www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr11-nr-nr182.htm

Reading the comments really made me wonder if the Minister - or her advisors - grasp the scale of risk associated with  the proposed PCEHR project.

Any large public projects carry substantial risk and large IT projects - and especially health IT projects - seem to be prone to nasty surprises and career ending outcomes.

Among the larger ones that have come seriously unglued we can think of the first attempt by Kaiser Permanente to undertake a major update of its IT infrastructure - that led to a write of in the many hundreds of millions of dollars - and the UK National Program for Health IT’s experience which is till playing out.

A very useful reference regarding all this is found here:

J Am Med Inform Assoc. 2009 May-Jun; 16(3): 291–299.

Health IT Success and Failure: Recommendations from Literature and an AMIA Workshop

Bonnie Kaplan, PhD and Kimberly D. Harris-Salamone, PhD 

The full text is here:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2732244/

Here is the Abstract:

Abstract

With the United States joining other countries in national efforts to reap the many benefits that use of health information technology can bring for health care quality and savings, sobering reports recall the complexity and difficulties of implementing even smaller-scale systems. Despite best practice research that identified success factors for health information technology projects, a majority, in some sense, still fail. Similar problems plague a variety of different kinds of applications, and have done so for many years. Ten AMIA working groups sponsored a workshop at the AMIA Fall 2006 Symposium. It was entitled “Avoiding The F-Word: IT Project Morbidity, Mortality, and Immortality” and focused on this under-addressed problem. Participants discussed communication, workflow, and quality; the complexity of information technology undertakings; the need to integrate all aspects of projects, work environments, and regulatory and policy requirements; and the difficulty of getting all the parts and participants in harmony. While recognizing that there still are technical issues related to functionality and interoperability, discussion affirmed the emerging consensus that problems are due to sociological, cultural, and financial issues, and hence are more managerial than technical. Participants drew on lessons from experience and research in identifying important issues, action items, and recommendations to address the following: what “success” and “failure” mean, what contributes to making successful or unsuccessful systems, how to use failure as an enhanced learning opportunity for continued improvement, how system successes or failures should be studied, and what AMIA should do to enhance opportunities for successes. The workshop laid out a research agenda and recommended action items, reflecting the conviction that AMIA members and AMIA as an organization can take a leadership role to make projects more practical and likely to succeed in health care settings.

----- End Quote:

A key section is found here:

What We Know—Lessons from Experience

Participants drew lessons from their research and experiences on how management might improve project success. These included:

• provide incentives, remove disincentives

Users may perceive that they have no time, or that what they are being asked to do moves work to them and away from others. Physicians, for example, would be more engaged if they experienced applications that helped them directly rather than providing disincentives to adopt the system. As an incentive, for example, physicians could get rounds done more easily if patient lists were ready when shifts begin.

• identify and mitigate risks

Determine the social risks, the IT risks, the leadership risks, the user risks, etc, and consider them early and often during the project. These risks and possible ways to mitigate them should become part of new or existing policies and procedures pertaining to the new system and incorporated into training.

• allow resources and time for training, exposure, and learning to input data

Participants described systems where clinicians had never used a keyboard or had exposure to computers, yet training was very limited. Sufficient training and time to learn need to be part of the implementation, and need to be on-going afterward.

• learn from the past and from others

Participants spoke of the need for studies of successes, failures, and how failing situations were turned around. They suggested longitudinal studies, qualitative studies, more focus on health care teams as a whole, and incorporating insights from change management, diffusion of innovation and technology, social science and sociotechnical theory, and multilevel frameworks. Although participants suggested drawing on existing theories and knowledge and also incorporating project management and methodology issues, they advised caution when doing so because of differences between health care and the business settings where models were developed. There also were calls for measurable evidence, including evidence of publication bias concerning project failure, and for various databases to be created

----- End Quote

As I see it we have a system in the PCEHR which pretty much goes against all of this:

First - as noted in the last few days the incentives to use the proposed PCEHR are distinctly lacking (see the News in yesterday’s blog and various Ministerial comments)

Second we note the is no ‘risk assessment’ or ‘risk analysis’ in the PCEHR Concept of Operations.

Third we find the Program / Project being driven by a politically driven rather that pragmatic time frame for delivery.

Last we not the PCEHR spends all of about 2-3 pages of 160 pages in the Concept of Operation on analysis of previous national and international projects - hardly an in-depth analysis.

As well as careful analysis of relevant past experience any IT Project Risk Analysis needs to assess:

1. Strategic Risks - what is out there that can or may impact on the shape and delivery of the project?

2. Budgetary, Cost and Resourcing  Risks - is the budget allocation secure and adequate - with a contingency - to deliver the program.

3. Management Risks - are those charged with delivery of the program experienced and capable to deliver the program. In this case it might also be termed execution risk.

4. Timing Risks - is the project plan and proposed timing structured in such a way as to make delivery reasonably achievable. Have the sequence of activities and their duration been properly planned to make delivery possible?

5. Technical Risks - are all the technologies, Standards etc. all proven and known to work and will the desired outcome be possible from a technical perspective.

6. Cultural Risks - is what is planned suitable for use in the work environment for which it is intended?

7. Security and Privacy Risks - As any IT project needs to address but most especially Health IT projects.

8. Sustainability Risks - What are the plans to continuing support of the outcomes of the project?

It seems to me the ConOps should offer an analysis of all these as well as a few pages on risk mitigation to be used starting with addressing this list at least. Of course all this should have been done before we stated off on this journey.

David.

Standards for The PCEHR is a Looking Like A Mess. This Is Just Really Just Hopeless.

This appeared a few days ago

Ceasefire over e-health standards

By James Hutchinson on Sep 13, 2011 6:44 AM

NEHTA standards head made redundant.

The Department of Health and Ageing has agreed to resume the funding required to develop the technical standards that underpin its $466.7 million personally controlled electronic health record initiative.

The department had reportedly cut funding to an e-health standards development program by Standards Australia over the current financial year.

Negotiations around funding for Standards Australia's work continued well into August. A spokesman for the national body said an agreement had since been reached.

"The priorities of standards-related work relating to the PCEHR will be determined in the near future," the spokesman said.

The Department of Health and Ageing was contacted for comment but did not reply at time of publication.

The department this week released its revised concept of operations for the e-health record as the latest in a number of steps towards its ambitious goal for launch of the records on July 1 next year.

"We don't apologise for being impatient for success because we know how beneficial the e-health revolution will be for patient care," health minister Nicola Roxon said upon releasing the revised document on Monday.

According to a program plan published in March, Standards Australia planned to develop at least 26 standards with funding from the National E-Health Transition Authority (NEHTA), a body close to the department.

NEHTA focuses on 'engagement' for standards

Government-driven standards development work also faced another potential setback after NEHTA made its standards manager, Tina Connell-Clark, redundant in an internal restructure last Friday.

In an internal email sighted by iTnews, head of architecture Dave Bunker announced the departure of Connell-Clark, who had led standards work at the organisation from 2008.

Lots more here:

http://www.itnews.com.au/News/271739,ceasefire-over-e-health-standards.aspx

With all this I thought I would check just where NEHTA’s Standards Catalogue was up to. As of a day or so ago we have:

http://www.nehta.gov.au/standards-catalogue

Standards Catalogue

The National E-Health Standards Catalogue (Standards Catalogue) consists of a collection of standards and specifications that are essential guidance for those who develop, sell, support, buy and implement e-health software in Australia. The catalogue provides a list of the standards recommended by, and specifications sourced or developed by, NEHTA, and is updated regularly.

......

The PCEHR Standards Catalogue currently being updated and will be available soon.

For any inquiries regarding Standards, please contact us at standards@nehta.gov.au

It is now known that Direkt Consulting gave NEHTA a PCEHR Program Standards Review on the 12^th of May (Version 1.1) and that NEHTA produced a Draft PCEHR Standards Plan for Review (V0.2) on 16 May.

This is meant to produce a set of Product Work Plans that will have material available as needed.

It is of note that the Direkt Report says there are 37 New Standards / Specification needed with 7 needing update and only 17 needing no work.

The loss of the NEHTA Standards Manager and the funding hiatus caused by DoHA (which was only sorted a few days ago) must have left things in something of a mess - to say the least.

Really it seems clear actual execution of any real activity is just not a strong suit for this mob!

David.

If You Think The PCEHR Is Such A Great Idea Think About This. You Need To Fix The Information First!

A key objective of the PCEHR is to make clinical information that is captured electronically shareable with the patient and other relevant clinicians.

Underlying this information sharing is the unstated assumption that the information held in source systems will be ‘fit for sharing’.

All one can say is that if this recently published study is any guide we are a zillion miles from that situation.

Here is a report on the study.

Electronic records 'not fit for purpose'

• By Michael Woodhead on  19 September 2011

The assumption that electronic medical records will improve care is unrealistic because data is often missing or inaccurate, an audit of emergency department records suggests.

A review of records for almost 2600 patients seen in NSW emergency departments with conditions such as diabetes, COPD and cardiovascular disease has found that discharge summaries were missing for 12-15% of patients.

In addition, where summaries were available, only three-quarters of the diagnoses were confirmed by the discharge summary audit, the study in Emergency Medicine Australasia (online Sept 19) found.

The study examined the accuracy of the diagnoses of chronic diseases in a ‘typical’ community hospital based on the ED information system (EDIS), and the NSW Health electronic medical record (EMR).

The accuracy of electronic records was best for diabetes and worst for asthma and COPD.

The full article is here:

http://www.6minutes.com.au/news/electronic-records--not-fit-for-purpose

Here is the abstract as published yesterday.

http://onlinelibrary.wiley.com/doi/10.1111/j.1742-6723.2011.01486.x/abstract

Health reform: Is routinely collected electronic information fit for purpose?

1. Siaw-Teng Liaw,
2. Huei-Yang Chen,
3. Della Maneze,
4. Jane Taggart,
5. Sarah Dennis,
6. Sanjyot Vagholkar,
7. Jeremy Bunker

Article first published online: 19 SEP 2011

DOI: 10.1111/j.1742-6723.2011.01486.x

© 2011 The Authors. EMA © 2011 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine

Abstract

Objective: Little has been reported about the completeness and accuracy of data in existing Australian clinical information systems. We examined the accuracy of the diagnoses of some chronic diseases in an ED information system (EDIS), a module of the NSW Health electronic medical record (EMR), and the consistency of the reports generated by the EMR.

Methods: A list of ED attendees and those admitted was generated from the EDIS, using specific (e.g. angina) and possible clinical terms (e.g. chest pain) for the selected chronic diseases. This EDIS list was validated with an audit of discharge summaries, and compared with a list generated, using similar specific and possible Systematized Nomenclature of Medicine – Clinical Terms (SNOMED-CT), from the underlying EMR database.

Results: Of the 33 115 ED attendees, 2559 had diabetes mellitus (DM), cardiovascular disease or asthma/chronic obstructive pulmonary disease; of these 2559, 876 were admitted. Discharge summaries were missing for 12–15% of patients. Only three-quarters or fewer of the diagnoses were confirmed by the discharge summary audit, best for DM and worst for cardiovascular disease. Proportion of agreement between the lists generated from the EDIS and EMR was best for DM and worst for asthma/chronic obstructive pulmonary disease. Possible reasons for this discrepancy are technical, such as use of different extraction terms or system inconsistency; or clinical, such as data entry, decision-making, professional behaviour and organizational performance.

Conclusions: Variations in information quality and consistency of the EDIS/EMR raise concerns about the ‘fitness for purpose’ of the information for care and planning, information sharing, research and quality assurance.

The two paragraph conclusion in the full article says it all:

Conclusions

The present study highlights what we already know – we are only as good as the information we have! The various purposes designated for the EMR as part of health reform are unrealistic if we cannot rely on data quality and consistency of our information systems. The current information quality and consistency of the EDIS/EMR system in a typical community hospital with an unaccredited ED needs improvement to easily support research. If it is not good enough for research, it is probably not good enough to promote and support safe and effective clinical practice.

Further systematic examination of the large repositories of routinely collected data is required to determine the fitness for purpose, which might be to share good-quality information among clinicians or to support electronic decision support systems. A logical next step is to repeat the present study with a representative sample of EDs and include a qualitative study of clinicians and information managers to understand the underlying reasons for any variations in data quality.

-----

NEHTA has recognised that ‘data quality’ is a critical issue (see page 46 of the PCEHR Concept of Operations) however it really has no idea how to actually fix the problem if the ‘management speak’ of the following 2 pages is to be read carefully. Their plan is (in summary):

4.2.1 Data quality

Ensuring a high standard of data quality is an essential requirement for the PCEHR System. High levels of data quality are required to assist healthcare providers and individuals in making safe healthcare decisions. Data quality within the PCEHR System will be ensured through a combination of validation of data loaded into the system, working with operators or source systems to improve the quality of data they are able to provide and by ongoing monitoring of data quality.

----- End Quote

The UK worked on this problem in the context of their shared EHR summary record and found a great deal of time, money and effort was required to get even close to clinical levels of reliability.

Doing a shared health record in haste and on the cheap as this plan suggests is going on, with but a brief outline plan for action, is a recipe for disaster in my view. I certainly don’t know any clinicians who would be interested in acting on the basis of the quality of information we see implied her as being planned for the PCEHR (Discharge Summaries etc.).

Much more careful planning, careful piloting and steps to ensure quality maintenance are vital - and none of this is quick or cheap!

David.

And Now For A Little Government Procurement Fun. You Be The Judge!

The following report appeared today in the Courier Mail.

Opposition claim of IT contract bias

• Koren Helbig
• From: The Courier-Mail
• September 20, 2011 12:00AM

QUEENSLAND Health bureaucrats ordered changes to an independent report to guarantee an IT supplier a multi-million-dollar government contract, the State Opposition says.

The troubled department last night vehemently rejected allegations it deliberately changed the report's scope to favour software company Cerner Corporation.

Queensland Health is now in negotiations with the US-based Cerner to build a $243 million electronic medical records system in Queensland hospitals.

Documents obtained by the Opposition under Right to Information laws show a public servant asked that extra information be added to the findings of a 2009 external investigation into potential suppliers.

Opposition health spokesman Mark McArdle said the emails, marked "confidential", asked that Cerner be highlighted as the only company with systems already in Australia. He said the change may have unfairly excluded other potential competitors.

It is the latest in a series of IT headaches for the Bligh Government, which is still battling to fix its disastrous health payroll system and was this month embarrassed by leaked reports detailing risks within other health technology projects.

In a statement last night, chief information officer Ray Brown rejected the latest claims as "categorically untrue".

He said an independent probity adviser had reviewed the process and found no reason to believe Cerner was treated with undue bias.

More here:

http://www.couriermail.com.au/news/queensland/opposition-claim-of-it-contract-bias/story-e6freoof-1226141253954

For your reading pleasure we are lucky to have the actual e-mails - so readers can be the judge if there was any issue with what was apparently going on behind the scenes.

The e-mails were made available under FOI so they are free for all to browse:

http://moreassoc.com.au/downloads/ieMR_gartner_emails.pdf

It will be interesting to see how this now plays out. Regular readers will know that implementations in NSW and Victoria of Cerner software have not been problem free but it also needs to be recognised that Cerner globally has been very successful in delivering working hospital systems elsewhere. Where any blame lies for issues in particular implementations is really not something that can be known without individual case analysis!

My suspicion, on the basis of the obvious evidence of a large number of successful implementations globally is that there is a need to closely examine how large scale, state-wide implementations are undertaken in Australia to see if there are major problems with that approach.

Others have also suggested that there are some software flaws and certainly few systems of the complexity of the Cerner product are likely to be ‘bug free’!

I keep an open mind but suspect there are a mix of causes!

We can all watch what happens now with interest!

David.