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Thursday, January 29, 2015

The Obama "Precision Medicine Inititative" and the Congressional "21st Century Cures Act."

During his recent 2015 SOTU Address, the President alluded to his forthcoming proposal to spur "Precision Medicine" -- a.k.a. "Personalized Medicine," focused in significant measure on basic and applied "omics" science for development of significantly more accurate and effective diagnostics and therapeutics.

Relatedly, now comes word of the release of  a Congressional "discussion draft" (pdf) of the "21st Century Cures Act."

The partisan bickering ensued before the toner was dry.
Dems balk on medical technology bill
By Darius Tahir, January 28, 2015

Democrats on the House Energy & Commerce Committee have withdrawn support from legislation that would loosen regulatory requirements on a broad range of new healthcare technologies, sources close to the legislative discussions say.

The sprawling 21st Century Cures Act, whose 393-page first draft was released on Jan. 27, is aimed at speeding up the adoption of next generation medical technologies. It seeks to foster drug development, including of antibiotics, by requiring the Food and Drug Administration to allow more “flexible” clinical trial design and gives medical-device makers more “innovative device review pathways.”

It also incorporates the Sensible Oversight for Technology which Advances Regulatory Efficiency (Software) Act sponsored by Rep. Marsha Blackburn (R-Tenn.), which would allow the FDA to take a risk-based regulatory approach to new healthcare information technologies. Its goal is to foster faster adoption of mobile medical applications, clinical decision-support tools and other healthcare-related software.

Rep. Frank Pallone (D-N.J.), the ranking member of the committee, said the draft legislation disappointed him because it “does not reflect true bipartisan collaboration.”

“In its current form, I am concerned that the nearly 400-page draft could create more problems for our healthcare system than it solves,” he said. “Further, the draft does not include any real dollars to fund additional basic research at the National Institutes of Health.”...
Below, I've stripped out the topical headings and sub-headings to give you a sense of where all of this might be headed.

Subtitle A—Patient-Focused Drug Development

Sec. 1001. Development and use of patient experience data To enhance structured risk-Benefit assessment framework.

Subtitle B—Surrogate Endpoint Qualification and Utilization

Sec. 1021. Evidentiary standards for the review of requests for the qualification of surrogate endpoints; Biomarkers partnership.

Sec. 1022. Enhancing the process for qualification of surrogate endpoints.
Sec. 1023. Transitional provisions for previous submissions for qualification of biomarkers as surrogate endpoints. 

Sec. 1024. Biannual reports to Congress.

Subtitle C—Approval of Breakthrough Therapies

Sec. 1041. Approval of breakthrough therapies.

Subtitle D—Antibiotic Drug Development

Sec. 1061. Approval of certain drugs for use in a limited population of patients. 

Sec. 1062. Susceptibility test interpretive criteria for microbial organisms.
Sec. 1063. Election to convey a portion of extended exclusivity period applicable to qualified infectious disease products.

Sec. 1064. Encouraging the development and use of new antimicrobial drugs.

Subtitle E—Priority Review for Breakthrough Devices 

Sec. 1081. Priority review for breakthrough devices.
Sec. 1082. CMS coverage of breakthrough devices to be supplied. 

Subtitle F—Accelerated Approval for Breakthrough Devices

Sec. 1101. Accelerated approval for breakthrough devices.

Subtitle G—Expanded Access

Sec. 1121. Expanded access policy as condition of expedited approval.
Sec. 1122. Notification of submitters of expanded access requests.
Sec. 1123. GAO qualitative analysis on individual patient access to unapproved therapies and diagnostics.

Sec. 1124. Expanded Access Task Force.
Sec. 1125. Finalizing draft guidance on expanded access.

Subtitle H—Facilitating Responsible Communication of Scientific and Medical Developments

Sec. 1141. to be supplied.

Subtitle I—Modernizing the Regulation of Social Media

Sec. 1161. Dissemination of information about medical products using the Internet.

Subtitle J—Streamlined Data Review

Sec. 1181. Streamlined data review program.

Subtitle K—Cures Acceleration Network

Sec. 1201. Flexible research authority.
Sec. 1202. Repurposing drugs.

Subtitle L—Dormant Therapies

Sec. 1221. Definitions.
Sec. 1222. Capturing lost opportunities and creating new cures for patients. 

Sec. 1223. Implementation and effect.

Subtitle M—New Therapeutic Entities

Sec. 1241. Extended exclusivity period for certain new drug applications and abbreviated new drug applications.

Subtitle N—Orphan Product Extensions Now

Sec. 1261. Extension of exclusivity periods for a drug approved for a new indi- cation for a rare disease or condition.


Subtitle A—21st Century Cures Consortium Act

Sec. 2001. Innovative Cures Consortium.

Subtitle B—Medical Product Innovation Advisory Commission

Sec. 2021. Medical Product Innovation Advisory Commission.

Subtitle C—Regenerative Medicine

Sec. 2041. Issuance of guidance on surrogate and intermediate endpoints for accelerated approval of regenerative medicine products.

Subtitle D—Genetically Targeted Platform Technologies for Rare Diseases

Sec. 2051. Genetically targeted platform technologies for rare diseases.

Subtitle E—Sensible Oversight for Technology Which Advances Regulatory Efficiency

Sec. 2061. Medical and health software defined.
Sec. 2062. Applicability and inapplicability of regulation.
Sec. 2063. Exclusion from definition of device.

Subtitle F—Building a 21st Century Data Sharing Framework


Sec. 2081. Standardization of data in Clinical Trial Registry Data Bank on eli- gibility for clinical trials.
Sec. 2082. Clinical Trial Data System.


Sec. 2085. Expanding availability of Medicare data.
Sec. 2086. Empowering patient research and better outcomes through CMS data.
Sec. 2087. Allowing clinical data registries To comply with HIPAA privacy and security law in lieu of complying with the privacy and security provisions of the Common Rule.
Sec. 2088. Access to CMS claims data for purposes of fraud analytics.


Sec. 2091. Commission on Data Sharing for Research and Development.
Sec. 2092. Recommendations for development and use of clinical data registries.

Subtitle G—Utilizing Real-World Evidence

Sec. 2101. Utilizing real-World evidence.

Subtitle H—Coverage With Evidence Development

Sec. 2121. Authority for coverage with evidence development for medical de- vices under the Medicare program.

Subtitle I—Combination Products

Sec. 2141. Regulation of combination products by the Food and Drug Administration.
Sec. 2142. GAO report on FDA regulation of combination products. Subtitle J—Modernizing Regulation of Diagnostics

Sec. 2161. to be supplied.

Subtitle K—Interoperability

Sec. 2181. to be supplied.

Subtitle L—NIH–Federal Data Sharing

Sec. 2201. Sharing of data generated through NIH-funded research.

Subtitle M—Accessing, Sharing, and Using Health Data for Research Purposes

Sec. 2221. Accessing, sharing, and using health data for research purposes.

Subtitle N—21st Century Chronic Disease Initiative Act

Sec. 2241. Plan for longitudinal study on outcomes of patients with a chronic disease.

Subtitle O—Helping Young Emerging Scientists

Sec. 2261. Funding research by emerging scientists through Common Fund.
Sec. 2262. Report on trends in age of recipients of NIH-funded major research grants.

Subtitle P—Fostering High-Risk, High-Reward Science

High-risk, high-reward research program.

Subtitle Q—Precision Medicine to be supplied.


Subtitle A—Clinical Research Modernization

Protection of human subjects in research; applicability of rules. Use of institutional review boards for review of investigational device exemptions.

Subtitle B—Broader Application of Bayesian Statistics and Adaptive Trial Designs

Sec. 3021. Clinical trial modernization.

Subtitle C—Postapproval Studies and Clinical Trials

Sec. 3031. Evaluations of required postapproval studies and clinical trials.

Subtitle D—Pediatric Research Network Improvement

Sec. 3041. National Pediatric Research Network.

Subtitle E—Global Pediatric Clinical Trial

Sec. 3061. Sense of Congress.


Subtitle A—National Institutes of Health

Sec. 4001. NIH research strategic investment plan.
Sec. 4002. Biomedical research working group to reduce administrative burden on researchers.

Sec. 4003. NIH travel.

Sec. 4004. Increasing accountability at the National Institutes of Health.
Sec. 4005. GAO report on Common Fund.
Sec. 4006. Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements.
Sec. 4007. Additional funding for NIH Common Fund.
Sec. 4008. Additional funding for NIH brain research.
Sec. 4009. NCATS Phase IIB Restriction.

Subtitle B—Advancing Research for Neurological Diseases

Sec. 4021. National neurological diseases surveillance system.

Subtitle C—Vaccine Access, Certainty, and Innovation PART 1—DEVELOPMENT, LICENSURE, AND RECOMMENDATIONS

Sec. 4041. Prompt review of vaccines by the Advisory Committee on Immuniza- tion Practices.
Sec. 4042. Review of transparency and consistency of ACIP recommendation process.

Sec. 4043. Guidance on vaccine development.
Sec. 4044. Meetings between CDC and vaccine developers.
Sec. 4045. Modifications to priority review voucher program for tropical diseases.
Sec. 4046. Guidance on changes to an approved application for biological products.
Sec. 4047. Expediting the process for export certifications for vaccines.
Sec. 4048. NIH vaccine research.

Sec. 4061. Requiring prompt updates to Medicare program upon issuance of ACIP recommendations.

Sec. 4062. Encouraging health plans to establish programs to increase adult immunization.

Subtitle D—Reagan-Udall Improvements Bill

Sec. 4081. Reagan-Udall Foundation for the Food and Drug Administration.

Subtitle E—FDA Hiring, Travel, and Training

Sec. 4101. TO BE SUPPLIED.

Subtitle F—FDA Succession Planning

Sec. 4121. Professional development of FDA staff.

Sec. 4122. FDA management succession planning.

Subtitle G—Disposable Medical Technologies

Sec. 4141. Coverage of certain disposable medical technologies under the Medicare program.

Subtitle H—Local and National Coverage Decision Reforms

Sec. 4161. Improvements in the Medicare local coverage determination (LCD) process.

Subtitle I—Telemedicine

Sec. 4181. Advancing telehealth opportunities in Medicare.

Subtitle J—Revise IPPS New Technology Add-On Payment (NTAP) Reimbursement Amounts

Sec. 4201. Coding and reimbursement reforms.

Subtitle K—Lowering Medicare Patients OOP Costs

Sec. 4221. Medicare site-of-service price transparency.

Subtitle L—Global Surgery Services Rule

Sec. 4241. Treatment of global surgery services rule.

Subtitle M—Providers Consolidation and Medicare Payments Examined Through Evaluation

Sec. 4261. Rulemaking that implements certain Medicare payment changes to consider effects on provider consolidation.

Subtitle N—Medicare Part D Patient Safety and Drug Abuse Prevention

Sec. 4281. Establishing PDP safety program to prevent fraud and abuse in Medicare prescription drug plans.

Sec. 4282. Part D suspension of claims payment.
Sec. 4283. Improving activities of Medicare Drug Integrity Contractors (MEDICs).

Sec. 4284. Requiring e-prescribing for coverage of covered part D controlled substances.

Subtitle O—Accelerating Innovation in Medicine

Sec. 4301. Establishment of manufacturer opt-out program for medical devices.

Subtitle P—Medicare Pharmaceutical and Technology Ombudsman

Sec. 4321. Medicare pharmaceutical and technology ombudsman.

Subtitle Q—Ensuring Local Medicare Administrative Contractors Evaluate Data Related to Category III Codes

Sec. 4341. Ensuring local medicare administrative contractors evaluate data re- lated to Category III codes.

Subtitle R—Advancing Care for Exceptional Kids

Sec. 4361. Findings.
Sec. 4362. Establishment of Medicaid and CHIP Care Coordination program for children with medically complex conditions as Medicaid State option.

Subtitle S—Continuing Medical Education Sunshine Exemption

Sec. 4381. Exempting from manufacturer transparency reporting certain transfers used for educational purposes.

Subtitle T—Medical Testing Availability

Sec. 4401. Clarification regarding research use only products.


Subtitle A—Manufacturing Incentives

Sec. 5001. Extension of exclusivity period for American-manufactured generic drugs and biosimilars.

Subtitle B—21st Century Manufacturing

Sec. 5021. Updating regulations and guidance on current good manufacturing practice requirements.

Subtitle C—Controlled Substance Manufacturing and Exports

Sec. 5041. Re-exportation among members of the European Economic Area.

Subtitle D—Medical Device Reforms

Sec. 5061. Third-party quality system assessment.
Sec. 5062. Valid scientific evidence.
Sec. 5063. Training and oversight in least burdensome means concept.
Sec. 5064. Recognition of standards.
Sec. 5065. Notification of marketing of certain class I devices.
Sec. 5066. General and specific uses.
Sec. 5067. Humanitarian device exemption application to in vitro diagnostics. Sec. 5068. Advisory committee process.

Subtitle E—Supply Chain Security for Devices

Sec. 5081. Short title.
Sec. 5082. Device distribution supply chain.
Sec. 5083. Authorized trading partners.
Sec. 5084. National licensing standards for wholesale device distributors. 

Sec. 5085. National licensing standards for third-party logistics providers. 
Sec. 5086. Waivers and exemptions.
Sec. 5087. Uniform national policy.

Sec. 5088. Penalties.
The legislative sausage-making process. Thus far only miniscule and vague references therein alluding to "health information technology" and "interoperability."

ONC Annual Meeting
Interoperable Health IT for a Healthy Nation

February 2 - 3, 2015
Washington Hilton
1919 Connecticut Avenue
Washington, D.C. 20009

The Office of the National Coordinator for Health IT (ONC) will hold the 2015 Annual Meeting February 2-3, 2015, at the Washington Hilton in Washington, D.C. The meeting will gather over 1,000 health IT partners for two days of plenaries and breakout sessions. Online registration has closed; however onsite registration will be available. The Annual Meeting will also be webcasted on February 2, 2015 and the morning plenary on February 3, 2015.
What has SHARP accomplished for EHRs?
'I would say in general that the SHARP programs were successful, but some were more successful than others'

January 29, 2015

After four years and $60 million, the ONC's Strategic Health IT Advanced Research Projects program is essentially done, and each project has made strides in improving various elements of EHRs. Those involved in SHARP believe their work has advanced the health IT field, but it remains to be seen if any of their innovations find their way into widespread use.

"I would say in general that the SHARP programs were successful, but some were more successful than others," said Douglas Fridsma, MD, former ONC chief scientist who departed in September to become president and CEO of the American Medical Informatics Association. Fridsma was effectively the point person for SHARP while at ONC.

With money appropriated by the 2009 HITECH Act, ONC issued grants in 2010 to four major institutions, to "address well-documented problems that impede the adoption of health IT," according to the program's website...
Medscape Medical News
President Requests $215M for 'Precision Medicine'

Alicia Ault, January 30, 2015

Washington, DC — Putting his money where his mouth is, President Obama will seek $215 million to finance the Precision Medicine Initiative he first mentioned in his State of the Union speech on January 20.

The funding request will be included in his fiscal 2016 budget, which will be sent to Congress on February 5.

"The time is right to unleash a new wave of advances in this area — precision medicine," said Obama at today at the East Wing of the White House. And he said he knew the time was right, in part, because "there is bipartisan support for the idea."

A centerpiece of the president's proposal is a million-patient research cohort that will depend largely on physicians and hospitals to help recruit participants and ensure there is continuous and long-term data collection and follow-up, Francis S. Collins, MD, PhD, director of the National Institutes of Health (NIH), told Medscape Medical News.

He likened the Precision Medicine Initiative to the Human Genome Project...

More to come...

Monday, January 26, 2015

An Epic development

How about some Mayo with your Epic?
Mayo taps Epic for EHR, revenue cycle management
Healthcare Dive Mayo Clinic announced this week that it would be abandoning its three current EHR systems in favor of a new contract with EHR giant Epic, which will now be the healthcare icon's sole EHR provider and strategic partner, according to a Mayo press release.

The plan is to deploy a single, integrated Epic EHR and revenue cycle management system at Mayo's main campus. Jilted in the deal are GE and Cerner, who were the providers of Mayo's current systems...
That's truly a big deal, particularly given this Mayo news:
Precision Medicine: Mayo Clinic Expert Describes Next Steps to Help More Patients

Rochester, Minn. – “Precision medicine” is becoming a national catchphrase after President Obama highlighted it in his State of the Union address. But what exactly is it? Richard Weinshilboum, M.D., acting director of the Mayo Clinic Center for Individualized Medicine, describes this new, rapidly advancing frontier in medicine and outlines 10 changes that would speed development and help more patients benefit from a personalized approach to health care:

What is precision medicine? In precision medicine, also called individualized medicine or personalized medicine, physicians use knowledge about a person’s personal genetic makeup to help determine the best plan for disease prevention, diagnosis and treatment. The mapping of the human genome in 2003 by U.S. scientists jump-started medical genomics; the Human Genome Project was an immense international collaboration that took 13 years and cost $3.8 billion. The National Institutes of Health’s National Human Genome Research Institute, which coordinated the project, estimates economic growth from that project at $798 billion.

"We are now poised to apply genomic technologies developed with the findings of the Human Genome Project into everyday patient care,” Dr. Weinshilboum says.
“However, if the U.S. is to remain the world leader in health care innovation and delivery, we need another national genomics effort that will accelerate scientific discovery and clinical implementation while continuing to encourage the rapid technological innovations and entrepreneurialism that have gotten us to this point."

What would help the U.S. continue to lead in precision medicine? President Obama’s call for a national initiative to advance individualized medicine, including increased funding to the National Institutes of Health to support advances in precision medicine, is an important step, Dr. Weinshilboum says. Other moves that would help include:

  • Adding bioinformatics to medical school and graduate school requirements to give physicians and other health care providers the tools they need to use genomic material.
  • Updating and expanding government regulations to keep up with the growth of genomic technologies and potential treatments, including providing alternative tracks for the development and use of medications for small subsets of patients.
  • Revising insurance guidelines to support genomic-based therapies.
  • Standardizing biobank activities, using the same terms and templates so biobanks are more universally useful.
  • Creating annotated, safe data repositories where all institutions can pool data and benefit from shared data while protecting patient privacy.
  • Developing a next generation of electronic medical records that can securely store genomic data or easily interact with secure genomic data storage warehouses to facilitate incorporation of genomics into routine medical care.
  • Using genomics to identify drugs that could be used as specialized cancer treatments.
  • Improving incentives for researchers to collaborate and work in teams.
  • Creating a national clearinghouse to match patients with genomic clinical trials.
  • Bringing together federal and state regulators to develop a clear pathway toward the approval of next generation-based sequencing tests.
What are some precision medicine terms that people might start hearing more frequently from physicians, researchers and policymakers?
  • Whole exome sequencing, also known as exome capture: A laboratory process that determines, all at once, the entire unique sequence of a person’s exome. The exome consists of all of the protein coding genes in a person’s DNA. These genes, which contain the instructions for how a cell behaves, account for an estimated 1 to 2 percent of
  • Whole genome sequencing: A laboratory process that determines, all at once, the entire unique DNA sequence of a person’s genome. There about 6 billion “letters” in every human genome; everyone is unique.
  • Genetic variants: Each of us is about 99.9 percent the same, genetically speaking. Even so, that 0.1 percent adds up to about 3 million individual genomic variants that differ between any two people. A major challenge in individualized medicine is finding the handful of variants that may lie behind a person’s cancer, diabetes, or Alzheimer’s disease, for example.
  • Bioinformatics: A research field that focuses on the interpretation of genomic data and seeks to build sophisticated systems that help scientists and physicians quickly locate variants that play roles in diseases. This is a rapidly growing area: Scientists and physicians can now generate data much more quickly than they are able to interpret it.
  • Next Generation Sequencing: Also known as high-throughput sequencing, next generation sequencing describes several new DNA sequencing technologies that allow scientists and physicians to decode and catalog large numbers of genomic sequences in a rapid and cost-effective manner.
It has been asserted that only ~10% of "health" is attributable to clinical interventions, as I noted in my August 13th, 2014 post. e.g.,

So, if we can bring genetic assay-driven therapeutics into the applied clinical settings, the percentage will change dramatically (notwithstanding that vexing socioeconomc Upstream issues will remain). Assuming, of course, we'll have a sufficient number of genetically adroit clinical staff -- and that the Epic EHR platform will be up to the genomic data management and workflow tasks.

And, one should add, that such new "omics" interventions will be affordable.


From THCB:
Three Recommendations for President Obama’s Precision Medicine Initiative

...[A]nnouncing the initiative is one thing.  As with all policy discussions, the devil is in the details – and there are three details specifically that could make the difference between political rhetoric and a policy that truly improves the health of American citizens.
  1. Focus on the entire process of the disease – starting with prevention. Because most chronic diseases show few symptoms until the disease has significantly progressed, treatments for cancer and diabetes patients are primarily at the disease management phase. However, we are acutely aware that the best way to “cure” cancer or diabetes is prevention, and prevention requires better early diagnosis. Unfortunately, we still lack convenient and accurate ways to diagnose for various cancers and diabetes. Given the high costs of treating advanced-stage chronic diseases, precision diagnosis of risk factors or disease progression will materially lower the costs of health care...
  2. Strategically target diseases. Particularly in cancer and type-2 diabetes, two of the fastest growing disease segments in the United States, there is a significant opportunity for precision medicine to improve early diagnosis and treatment, and lower the costs of care. Remember, we tackled HIV and AIDS issues over the past thirty years with a precise target (HIV) and with research focused on quickly translating basic science to clinically effective and safe drugs. Because cancer and diabetes are systemic diseases, affecting multiple aspects of a human body, focusing on translational science based on specific types of cancer or specific aspects of diabetes may in fact accelerate not only the understanding of the diseases but also improve the treatment methods at each stage...
  3. Set standard definitions and metrics. One of the major challenges in migrating toward precision medicine is lack of a common clinical language and metrics that help us to refine our interpretations and focus our messages to physicians and patients. Because cancer and diabetes are still treated in the realm of intuitive medicine, different physicians can provide different opinions on these diseases. Although we need to appreciate individuals’ genetic and biological uniqueness in discussing chronic diseases, precision medicine cannot establish deep roots without more commonly accepted definitions and associated metrics...
Indeed. Recommendation #3 resonates with me in particular.

More to come...

Thursday, January 22, 2015

DeSalvo gets a salvo

The natives are restless.

January 21, 2015 

Karen B. DeSalvo, MD, MPH
National Coordinator for Health Information Technology
Office of the National Coordinator for
Health Information Technology
U.S. Department of Health and Human Services Hubert H. Humphrey Building, Suite 729D
200 Independence Avenue, SW
Washington, DC 20201 

Dear Dr. DeSalvo: 

The undersigned organizations are writing to elevate our concern about the current trajectory of the certification of electronic health records (EHRs). Among physicians there are documented challenges and growing frustration with the way EHRs are performing. Many physicians find these systems cumbersome, do not meet their workflow needs, decrease efficiency, and have limited, if any, interoperability. Most importantly, certified EHR technology (CEHRT) can present safety concerns for patients. We believe there is an urgent need to change the current certification program to better align end-to-end testing to focus on EHR usability, interoperability, and safety. We understand from discussions with the Office of the National Coordinator for Health Information Technology (ONC) that there is an interest in improving the current certification program. For the reasons outlined in detail below, we strongly recommend the following changes to EHR certification:
  1. Decouple EHR certification from the Meaningful Use program;
  2. Re-consider alternative software testing methods;
  3. Establish greater transparency and uniformity on UCD testing and process results;
  4. Incorporate exception handling into EHR certification;
  5. Develop C-CDA guidance and tests to support exchange;
  6. Seek further stakeholder feedback; and
  7. Increase education on EHR implementation.
Entire nine page letter here (pdf)

"Ensuring patient safety is a joint responsibility between the physician and technology vendor and requires appropriate safety measures at each stage of development and implementation. While training is a key factor, the safe use of any tool originates from its inherent design and the iterative testing processes used to identify issues and safety concerns. Ultimately, physicians must have confidence in the devices used in their practices to manage patient care. Developers must also have the resources and necessary time to focus on developing safe, functional, and useable systems.
Unfortunately, we believe the Meaningful Use (MU) certification requirements are contributing to EHR system problems, and we are worried about the downstream effects on patient safety..."
Opportunities for EHR Science?


This is sad.
Ebola Is Wiping Out the World’s Gorillas
In just four decades, Ebola has wiped out one third of the world’s chimp and gorilla populations. If it continues, the results will be devastating.

While coverage of the current Ebola epidemic in West Africa remains centered on the human populations in Guinea, Sierra Leone, and Liberia, wildlife experts’ concern is mounting over the virus’ favorite victims: great apes. 

Guinea, where the epidemic originated, has the largest population of chimpanzees in all of West Africa. Liberia is close behind. Central Africa is home to western lowland gorillas, the largest and most widespread of all four species. Due to forest density, the number of those infected is unknown. But with hundreds of thousands of ape casualties from Ebola, it’s doubtful they’ve escaped unscathed.

Animal activists are ramping up efforts to find an Ebola vaccine for great apes, but with inadequate international support for human research, their mission could be seen as competing with one to save humans. Experts from the Jane Goodall Institute of Canada insist such apprehension would be misplaced. Two streams of funding—one for humans, one for apes—can coexist in this epidemic, they assert, and must.

“The media was really focusing on human beings,” Sophie Muset, project manager for JGI, says. “But it has been traumatic to [the great ape] population for many years.”...

The dwindling population of both species, combined with outside poaching threats, means Ebola poses a very real threat to their existence. To evaluate the damage thus far, the Wild Chimpanzee Foundation is conducting population assessments in West Africa, with the goal of getting a rough estimate of how many have died. Given the combined damage that Ebola has inflicted on this population, the results are likely to be troubling.

In a way, great apes are Ebola’s perfect victims. Acutely tactile mammals, their dynamic social environments revolve around intimacy with each other. Touching hands, scratching backs, hugging, kissing, and tickling, they are near constantly intertwined—giving Ebola a free ride...
Wow. It ain't all about us.


From Healthcare IT News.
The experience of interoperability thus far
Support from EHR developers for clinically relevant workflow will be critical

John Halamka
...HL7 messaging addresses lab result and public health use cases very well. Lab results interfaces are straight forward, however there is still some need to reduce optionality in implementation guides so that the average lab interface costs $500 and not $5000. Public health transactions for immunizations, reportable lab, and syndromic surveillance are standardized from a content perspective but  there is still a need to specify a single transport mechanism for all public health agencies.

CCDA documents address transitions of care use cases reasonably well. CCDA is easier to work and parse than CCD/C32 because it has additional constraints and specifications, but there is still enough optionality that merging CCDA data into an EHR can be challenging. In addition, most EHRs generate a CCDA automatically and include all data that may possibly be relevant. In some cases, this leads to CCDAs that are rendered at 50+ pages. We need to reduce optionality so that CCDAs are easier to generate correctly and parse. EHR workflow needs to better support the creation of clinically relevant documents with narrative and data more specific to transitions.

Direct was a good first step for transport -- we needed to pick something. We could have required sFTP, REST, SOAP, SMTP/SMIME or even Morse Code as long as it was completely standardized. Unfortunately, we picked multiple options. Some EHRs use XDR (a SOAP transaction) and some use SMTP/SMIME. Whenever standards have an "OR", all vendors must implement an "AND". XDR must be translated into SMTP/SMIME and SMTP/SMIME must be translated into XDR.  The reality of Direct implementation has shown us that this optionality provides a lot of plumbing challenges. Certificate and trust issues are still an ongoing project. Getting data from medical devices via Direct is challenging since devices tend to use heterogeneous transmission protocols. Finally, SMTP/SMIME was never designed for large payloads of multiple files, so sending datasets greater than 10 megabytes can be a struggle. The use of XDM for zipping files before they are sent is overly complex to use as part of a transport protocol.

Although Direct works, it is often not well integrated into the EHR workflow.

FHIR, as discussed in multiple recent posts, can help address these challenges and leverage the lessons learned. The FHIR concept is that every EHR will provide a standardized interface for the query, retrieval, and submission of specific data elements and documents using a web-based RESTful transport mechanism and OAuth security. This use case can easily support unique modules or “bolt on” application functionality to EHRs. It significantly simplifies the interfacing challenge, works for large payloads, and minimizes optionality. There are no multiple transport options, no certificates to manage, and the query/retrieve processes can occur behind the scenes, enabling smoother workflow.

FHIR can even be helpful as a transition strategy while Direct is still used for pushing payloads between EHR. If FHIR/REST/OAuth replaced the XDR/XDM options of Direct, that provides a glide path to the eventual end to end replacement of Direct with FHIR

Once FHIR is available, EHR vendors should design a user experience that follows the IEEE definition of interoperability -- “the ability of a system or a product to work with other systems or products without special effort on the part of the customer."...
 My concerns regarding FHIR® persist. Beyond seamlessly integrating these "interfaced" data into "clinically relevant workflows" in ways that [1] don't put more sand in the workflow gears, and [2] don't leave the "imported" data reposed somewhere outside the recipents' RDBMS -- begging the question of easily assembling of the most recently updated complete legal patient record (vis the clinician acting upon the imported data elements) -- who is going to have to pay for all of this coding and QA validation work? Will FHIR ex/im functionality come to be required for ONC EHR certification, on the vendors' dime?

While I would say "yes," color me dubious.

What about HIPAA audit trail "chain of custody" data considerations?

I'm just asking. Below, from survey findings I recently saw in "API Integrity is a 'Must-Have' in the API Economy."


Cheryl and I attended the ASQ East Bay Section 0618 meeting Thursday evening. Very nice.
Please welcome our newest distinguished guest, Ms. Ritu Ganguly of ServiceMax Inc.  She will be presenting on the topic of "Testing in the Mobile World?"

Ms. Ritu Ganguly will lend her professional perspective on the emerging challenges of bringing quality to a mobile connected world.  Areas of discussion will include:
  • Advantages and Disadvantages for QA engineers
  • Basic similarities to the status quo, but note the differences...
  • What skills sets are needed by mobile testers?
  • How is Automation planning affected?
Ritu Ganguly is an experienced executive with over 18 years of experience in Quality, Technical Program management, Release management.  Her experience is in varied industries including ERP, CRM, HCM, Service and Healthcare software.  Her key strengths are building effective teams, fixing organizational issues, change management, quality process and software delivery.  Her professional journey includes mentoring and coaching quality engineers and managers for the last 10 years.  Most currently she was a part of Tech women mentorship program sponsored by the U.S State Department.  In addition, she was filmed by Stanford University for She++ videos to promote women in computing.

Ritu Ganguly has a Bachelor’s degree in Computer Science and a Master’s in Medical Informatics.  Born in India, she and has lived in Europe, Middle East and the U.S.  Her professional experience has been working for large enterprises such as PeopleSoft, Oracle, Salesforce and John Deere, as well as small startups such as Health Quality.

Currently she is a Vice President of Quality and Strategic Ops at ServiceMax Inc. ServiceMax is a Leader in Field Service Management software.

Specialties include:

  • Software development and quality management.
  • Quality of service (QOS) for Cloud Computing and Software as a Service  (SaaS)
  • Agile methodology and Scrum
  • Talent management, Team building, Career planning and development
  • Public Diplomacy, Global mentorship
  • Women empowerment
Excellent, thought-provoking presentation and discussion. Given the increasing penetration of mobile digital tech ("mHealth") in the healthcare space, issues pertaining to software (and hardware) QA will be ever more critical. I worry that "QA" in Mobile "apps" is to a distressing degree reactive, i.e., done on the backs of customers in the wake of uploaded bug/crash complaints ("Ignore" / "Send Report" / "Restart"). As a fellow attendee put it, "everything is now always in beta."

I am not at all mollified by the dismissive assertion you often hear from some vendors (particularly those claiming to be "doing Agile"): "We're ALL in QA."

Show me the comprehensive, executed test plans and the upshot documentation. Show me your QMS Manual.

More to come...

Wednesday, January 21, 2015

ICD-10: Be Very Afraid

Providers Fear ICD-10
By Katie Wike, Health IT Outcomes

Experts at AHIMA say ICD-10 deadline fears could be a contributing factor to physicians’ reluctance to perform testing.

Usually, providers cite financial reasons, time constraints, and limited staff when explaining their reluctance to adopt ICD-10. Now, an AHIMA report published by Perspectives in Health Information Management indicates that - put simply - fear is a factor as well.

The top concerns cited by the physicians participating in the AHIMA focus groups were
  • electronic health record software readiness
  • increase in documentation specificity and time
  • ability of healthcare professionals to learn a new language
  • inadequacy of current training methods and content
EHR Intelligence reports many of these physicians “expressed straight-up fear about how the new codes will impact their practices.”...
Will Congress kick this can down the road yet again? Rumors waft that such may be embedded in the next "SGR Doc Fix" legislation.

On the other side of the coin, ya gotta love this:
Why another ICD-10 delay could threaten national security
January 20, 2015 | By Susan D. Hall, Fierce Health IT

Though some medical groups keep pushing for yet another delay in ICD-10, Juliet Santos of consultancy Leidos Health, argues that another delay could be a threat to national security.

Santos, in an article at ICD-10 Monitor, says another delay could hobble the United States in the public surveillance of deadly health threats.

"Sicknesses and plagues have become weapons in modern-day warfare. Weaponized bioterrorism is rampant in other countries. ... We cannot prevent, monitor, track, manage, and control what we cannot see or find," Santos writes, mentioning ICD-9's non-specific and sometimes missing codes.

The new coding system will allow the U.S. to respond better to deadly outbreaks such as Ebola, she says. Although the specificity of ICD-10 has been the brunt of jokes--it includes nine different codes reflecting injury inflicted by a turkey--in ICD-9, Ebola is classified as 078.89, Other specified diseases due to viruses, a designation used for multiple viral diseases that have not been assigned a specific code. In ICD-10, it would have its own code--A98.4, Ebola.

"ICD-10 allows us to track and monitor patients with diseases similar to Ebola, because the codes are specific, the severity of illness is detailed, and we can determine illness rates as well as death rates," Santos writes...
Ahhh... yes, Ebola. Might the significantly increased granularity of ICD-10 vis a vis ICD-9 mitigate the coding problem I have called "Lossy Compression?"


These two animatronic co-presenters provide dramatic evidence of just how far life-like anthropic robotics have come.


 Wow. This one's a doozy.
...The job of prophets has always been to strip commoners of their ability to make independent decisions. Today’s prophets of disruptive innovation are showing us the road to becoming Roman patricians spending our entire lives sprawled on fainting couches while being fanned and fed gorgeous grapes by beautiful machines. The first thing we must do is to offload decision making to the precursor of the slave-savant machine of the future, so it can learn and practice the art and science of pleasuring us. Letting your GPS decide how to get from point A to point B is one example, and letting Google decide what you should read is another, although the latter may soon become obsolete, since enjoying grapes on your couch does not require any reading. Letting your “phone” decide when you should stand and when you should sit, when to eat and what to eat, and when you feel and how you feel is the next step in our evolution towards a perfect union between amino acids and silicon compounds.  

Perhaps nothing illustrates our glorious path to heaven on earth better than health care, and befittingly so, since health is life, hence health care is life care, is everything. The old definition of health care included mostly restorative medical activities to one’s health, but as the value of people keeps declining in an overpopulated global economy, and the costs of repairs are increasing, a more expansive, machine oriented, definition seems in order. People, you see, are essentially carbon-based machines, like say cars, the only analogy simpleminded voters seem to comprehend. To reduce your lifetime expenses on your car, and to enjoy a reliable vehicle for the duration, you need to have all the maintenance done on schedule (e.g. oil changes, tire rotation, filters, belts, etc.), drive carefully and obey the law, use the car sparingly, without too much starting and stopping, and you should wash and wax regularly, and generally keep it nice and clean inside and out.

You get the recommended preventive care for your model, all the screenings and tests, so any early signs of malfunction can be addressed, and you swallow all the recommended additives to make operations smooth and well lubricated, without undue stress to any of your parts, especially the feeble brain part. You refrain from reckless activities, and keep your mind and body clean on the inside and on the outside. The prophets, or futurists, as they prefer to be addressed today, are guiding us to all sorts of little silicon parts that we can incorporate in ourselves on the incremental road to transferring the limited intelligence functionality of biological creatures to superior artificial components. This simple process of artificial evolution towards a brighter future does not seem to come naturally to most people. These things never do. This is precisely why piety and obedience need to be enforced by cannons and laws, and here and there a few weaklings or outright skeptics must be made examples of what people should fear most...
From "Artificial Intelligence" by Margalit Gur-Arie

More to come...

Tuesday, January 20, 2015

Announcing the launch of Dr. Jerome Carter's Clinical Workflow Center

I have for some time closely followed the postings of Jerome Carter, MD at his blog EHR Science. Now comes his new initiative (I've known about it since last week, and have registered there, but he asked me to keep quiet about it until he went "live"). I know we're all now in the thrall of sexy cutting-edge healthcare space digitech, but it behooves us to not lose sight of some critical fundamentals. HIT devices and software apps are just tools. They still have to be effectively embedded in the workflows. Yeah, "disruption" is now a way cool term among the digerati and econ theorists, but actual disruption of clinical workflows makes those in the trenches crazy --  and risks harming or killing patients.

Clinical Workflow Center is a site dedicated to everything clinical workflow. It was created with the following goals in mind: 1) teaching clinical workflow analysis methods and 2) demonstrating the mathematical properties of clinical workflows and how those properties can be used to solve real-world problems. Since I consider workflow analysis to be a fundamental informatics skill, there are tutorials covering important workflow concepts and analysis techniques.  A Q&A forum is provided to for those who wish to share and ask questions. Resource pages offer a link to a wide varierty of useful materials.  Clinical Workflow Center is a companion site to EHR Science.

Why create a site decidated to clinical workflow topics?
Workflow disruptions are increasingly being recognized as workarounds, usability issues, safety concerns, and CDS problems. The first step to solving any problem is recognizing that it exists. In the case of HIT, this means acknowledging that clinical care consists of a series of specialized workflows. Clinical care consists of directed sequences of tasks that use, generate, or share information and that involve one or more individuals or machines. If the task sequence is wrong, the information incorrect or unavailable, or the wrong people, software or equipment involved, problems occur.

EHR system-clinical work impedance The automation of clinical care with current EHR systems has resulted in numerous complaints from clinical professionals who are fed up and discouraged by systems that make their jobs harder to do. The number of workflow disruptions that occur as a result of EHR use should surprise no one. Disruptions were to be expected because EHR systems are archival systems that do not contain models of clinical work. Making matters worse is the fact that EHR systems have their own internal workflows. Consequently, a good portion of EHR training is spent helping EHR users learn to adapt their workflows to those of the software. Thus, training times are one hint of impending EHR system-clinical work impedance and attendant clinician misery.

The problem with current clinical workflow approaches Beyond training, entire organizations have to adapt their processes to match the hard-coded workflows of EHR systems. Recent demands for improved system usability indicate the amount of misery that EHR-clinical work impedance has caused. However, the solutions proposed do not seem to grasp just how fundamentally important workflow issues are.

Understanding exactly how clinical work is disrupted or enhanced, whether using software or not, requires the ability to precisely model clinical work.   And here is where the first major problem arises. Most modeling approaches used in clinical settings are based on flowcharts and swim-lane diagrams. Neither of these tools offers a means to capture all information movements, resource interactions and complex task sequences in one unified model. Unfortunately, attempts to improve the fidelity of workflow models often involve adding UML (e.g. state, activity) and other diagrams to the mix such as data flow diagrams. The key to better modeling is not more diagrams, but rather a single framework that allows for representation of all workflow concepts.

Obviously, detail is required to determine how the information needs of a nurse doing a patient intake are best mapped to his/her physical actions. This leads to the second problem: current workflow modeling efforts are usually insufficiently detailed for the processes they represent. This lack of detail is evident in workflow modeling training materials (see Clinical Workflow Analysis: The Value of Task-Level Detail ).

Workflow modelers seeking to add detail to their diagrams have another problem: there are no formal standards for encoding clinical work such as task names, step increments, information requirements, or notation symbols. Lacking such standards, models of the same workflows from different modelers will likely differ significantly. Such variation impedes learning and the progress of clinical informatics as it concerns understanding the interplay of clinical work and clinical care software (see Modeling Clinical Workflows and Processes). Fortunately, there has been a significant amount of workflow research in the last 20 years, and all of it can be applied to health care.

Workflow research outside of clinical care Automation of business processes has been a major focus of workflow research in the computer science, engineering and business communities. While automating processes is a worthwhile goal, workflow research — especially that focused on creating process models — can also be used to study clinical care activities at the lowest levels and build abstract models for analysis. Automating a process before fully understanding it can be disastrous. If one is losing money because of bad billing processes, automating those processes “as is” will result in bigger losses. Thus, some degree of analysis and modeling are essential before any attempts at automation. Clinical organizations that have been successful in implementing clinical software get this point.

Workflow patterns have the ability to express every major aspect of clinical workflows. Yes, they must be adapted to clinical use, but the basic concepts stand. Even better, workflow patterns and Petri nets are based in mathematics, which assures that precise meanings and notations are possible. Again, some changes and adjustments are required for clinical care, but the required changes are not rocket science. Aside from workflow patterns and Petri nets, I will go out on a limb (not far) and state that every clinical workflow (e.g., task sequence, information movements, and resource interactions) can be represented by a combination of common mathematical objects–logic, sets, functions/relations, and graphs. It is time to take the rich legacy of workflow research from computer science, engineering and business and apply it to understanding how clinical care happens.

Workflow disruptions by any other name…When caring for a patient, information is important. When and/or where in a care process information is required, collected, saved or shared are not simply usability issues, or safety problems, or human factors concerns, they are basic workflow issues as well. Addressing information needs requires close attention to workflow tasks and how they are sequenced. Who or what will participate in or complete a task are likewise workflow issues.

Given the importance of workflow to clinical care, the ability to expertly conduct workflow analyses should be right up there with being able to normalize a database or understand basic programming concepts as a training curriculum objective. In light of the fact that so many aspects of software selection/implementation, safety, usability, and CDS are workflow-based, clinical informaticists should be experts in analyzing and modeling clinical processes.
I hope this effort gets significant traction. Clinical workflows are irreducibly complex, high cognitive burden processes, and, given that digital health IT is not going away, the topic needs more effective and more widely visible analytical scrutiny and collaboration in pursuit of material improvement.

to wit

We’re all dressed up with nowhere to go. We’ve got our labs, real-time wireless sensor data, genomic sequence information, and images. Our ability to generate big medical data about an individual has far outstripped any semblance of managing it, and we can’t even build the full GIS yet. There is not a single electronic medical record (EMR ) system today that is set up to bring all this data together in a meaningful way— not just to aggregate it, but to provide the full analysis of all one’s medical information. It’s like we invented the printing press but haven’t figured out the card catalog. This isn’t necessarily because no one has tried; there are plenty of obstacles, but also, in spite of them, some early signs of progress. We’re talking about access, not ownership, a baby step in the right direction... [pg 125]
Doctors and the Medical Community 
With disinclination to change embedded in the medical community, reflected by the average time gap of seventeen years from innovation to adoption in medical practice, we need a cultural change. While digital native doctors just coming out of medical school or finishing residency training understand the sea change that is unfolding, there are millions of practicing physicians around the world who do not. We don’t have time to wait for a new generation of doctors and health care professionals to take hold. Cultural change is exceedingly difficult, but given the other forces in the iMedicine galaxy, especially the health care economic crisis that has engendered desperation, it may be possible to accomplish. An aggressive commitment to the education and training of practicing physicians to foster their use of the new tools would not only empower their patients, but also themselves. Eliminating the enormous burden of electronic charting or use of scribes by an all-out effort for natural language processing of voice during a visit would indeed be liberating... [pg 289]

Topol, Eric (2015-01-06). The Patient Will See You Now: The Future of Medicine is in Your Hands Basic Books. Kindle Edition.
Fabulous book.

Dr. Carter certainly has the Cred in this area.
Jerome H. Carter, MD, FACP, FHIMSS  is a board-certified internist who has been active in the field of medical informatics since completing a fellowship in 1987. He is also Adjunct Clinical Associate Professor of Medical Education at Morehouse School of Medicine (MSM) in Atlanta, GA.

Dr. Carter was previously Assistant Professor of Medicine at the University of Alabama-Birmingham (UAB) where he was Director of Informatics for the 1917  Patient Care and Research Clinic. At the 1917 Clinic, he led a five-year effort to design, build, and implement an electronic health record system optimized for patient care and outcomes research. During that time, he also directed the selection and implementation of a dental practice management and electronic record system.

While at UAB, Dr. Carter was also a member of the graduate faculty in the Master of Health Informatics Program. For six years, he was course director of “Clinical Documentation and Information Systems in Support of Patient Care”, which addressed issues related to the implementation and use of clinical information systems. A major emphasis of the course was the analysis of information system implementations in a variety of settings. Over the period 1995 to  2001, more than 40 health care entities from small practices to hospitals were studied in an effort to understand what makes for successful implementations.

Dr. Carter is the editor of Electronic Health Records, Second Edition (April 2008), published by the American College of Physicians. He served as a member of the American College of Physicians' Subcommittee on Medical Informatics from 1993-2001 (Chair, 1997-2001). From 2003 through 2007, he served on the Board of Scientific Counselors, Lister Hill Center, of the National Library of Medicine. Dr. Carter was co-chair of the HIMSS Electronic Health Records Adoption Task Force from  2007  until 2009.

Dr. Carter is a member of the following organizations: American College of Physicians, Association for Computing Machinery, American Medical Informatics Association, Healthcare Information and Management Systems Society,  IEEE - Computer Society, and CompTIA.
From EHR Science
One thing that seems important to address from the outset is the definition of clinical workflow. There are many definitions of workflow concepts available. I favor those provided by way of workflow patterns. Here are the definitions provided by Russell, et al. (1).

A workflow or workflow model is a description of a business process in sufficient detail that it is able to be directly executed by a workflow management system. A workflow model is composed of a number of tasks which are connected in the form of a directed graph.
These definitions are focused on automation and not clinical work. I would like to adapt these definitions, and workflow patterns in general, for clinical work. Should these efforts be successful, the result would be a set of shared conventions (e.g., definitions, analysis methods, terminology, modeling representations) for clinical workflow analyses and models that are easily shared and understood across clinical sites and application domains—usability, CDS, patient safety, software design. And, in keeping with the definitions provided by Russell et al., these models would also be executable by workflow technology. Flowcharts and swim lanes are great for discussions, but they are not executable.
Here are the definitions that will be used on CWC.

  • Clinical Work – Activities performed to assess, change or maintain the health of a patient.
  • Clinical Process – A specific clinical work activity undertaken by one or more clinical professionals with a specific start point, end point, and an expected outcome.
  • Clinical Workflow – The directed series of steps comprising a clinical process that 1) are performed by people/equipment/computers and 2) consume, transform and/or produce information. (Note that patient outcomes count as information.)
  • Clinical Workflow Model – A human-readable visual representation of a clinical workflow that can be executed by workflow technology.
One of my old REC "directed graphs." Fairly high level, marginally adequate. Conducted a pre-EHR implementation clipboard/walk-thru interview of the doc and his staff. Tried to compactly show what would go away and what would change via the conversion from paper to electronic.

The problem with these is that they are simply "logic flows" (laid out to fit pagination constraints to boot) and do not depict the time consumed, or the hand-offs, explicitly (my crude proxy for the hand-offs was color-coding).

Hand-offs ("swimlanes") and time consumption might look like this:

Click to enlarge

See my prior post Clinical workflow: "YAWL," y'all? for more of my brief workflow concept illustrations.


From the President's 2015 SOTU transcript: 
"21st century businesses will rely on American science, technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine — one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes — and to give all of us access to the personalized information we need to keep ourselves and our families healthier.

I intend to protect a free and open internet, extend its reach to every classroom, and every community, and help folks build the fastest networks, so that the next generation of digital innovators and entrepreneurs have the platform to keep reshaping our world."
As noted on, 
POTUS Just Announced a New Precision Medicine Initiative
Precision medicine is an emerging approach to treating illnesses that takes into account a patient’s individual genetic make-up as well as molecular subtypes of diseases to improve the chances of successful treatment.
We'll have to see what comprises the details.

More to come...