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Francois Bolduc (second from right) and his University of Alberta team are helming a project to develop an AI chatbot for families with children who have neurodevelopmental disabilities. (Courtesy: University of Alberta)

A mother doesn’t know what to do. Her autistic son is having severe difficulties, leading to dramatic problems at home. But they live in a rural part of western Canada, and a specialist appointment is still weeks away.

Soon this mother will be able to ask for immediate help — courtesy of an artificial intelligence (AI)-powered chatbot offering proven advice from the literature.

The AI machine will be able to guide the mother and son in their most crucial time to the best way to deal with the dynamic domestic situation, according to the developers, led by François Bolduc, M.D., a pediatric neurologist at the University of Alberta.

While a growing number of healthcare chatbots are proposed and being built, this one is dealing with a level of human sensitivity surrounding human development which may set it apart.

“That’s what’s kind of unique about this project, many projects are born from AI, but do not necessarily have tight connection with the health of the education sector, which is kind of a very strong thing in my mind, because it gives us this qualified way of processing the questions of that mom,” said Bolduc, in a recent interview with 

The development of the chatbot is underway through a three-year, $1.5-million grant from the Canadian Institutes of Health Research and Natural Sciences and Engineering Research Council of Canada, as well as a development grant from Kids Brain Health Network. Joining Bolduc and his team will be those from the University of Calgary, McGill University, and York University.

Key to the concept is providing resouces as early as possible — resources offered at the clinic, but which can now be accessible from the comfort of the home, said Bolduc.

The guidance would point to vetted Internet sources, with medical and behavioral advice that is tried and true from previous cases.

Although some skepticism of the burgeoning healthcare chatbot market 

, the timeliness and sourced data could make a huge difference to get families in a difficult domestic situation the help they need, at the moment its most needed.  

“A chatbot is perfectly suited for that. It’s there 24/7, you can access it when you have time, you can quit it and come back to it,” he said. “This is really trying to improve quality of life and improving functionality. It’s not going to change the individual… but I think it will make the world a little bit easier for individuals with neurodevelopmental disabilities to live in.”

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Articles

Chatbot is just the latest of the machines tasked to help patients.

University of Alberta AI Chatbot to Help Families of Kids with Neuro Issues

The pathologists take a sample of tumor tissue, and sequence its entire genetic code. The advanced computer program helps the oncologists process the results, homing in on certain mutations among a group of 400 targets. The genetic hallmarks of the disease are compiled in a text file that is analyzed and transmitted securely by artificial intelligence.

Ten to 15 minutes later, the computer has pulled a review out of millions of pages from the scientific literature — producing a selection of abstracts and pending trials.

From there, the battle against the cancer at the molecular level can proceed, after a consultation of a Tumor Board at the Les Hôpitaux universitaires de Genève (HUG) in Switzerland.

The use of Watson for Genomics, the search engine developed for IBM, has now been used for a dozen cancer patients at the Swiss health system since Aug. 1, becoming the first European site to use the technology.

The oncologists and specialists envision using it for 250 patients per year. While it has been in use in the U.S. and Asia, this brings a new level of automation to the traditionally manual searches conducted by treating oncologists in Europe, according to IBM.

“Already in use in the U.S. and Asia, HUG is the first university hospital in Europe to adopt Watson for Genomics and we are excited to work together to accelerate personalized, evidence-based care for its patients,” said Mark O'Herlihy, IBM Watson Health, managing director, EMEA.

Two institutions that use the Watson technology in the U.S. are Mayo Clinic and the Massachusetts Institute of Technology, according to a statement on the new deal.

Watson for Genomics is being touted for its security aspects — namely that the information transmitted includes no identifying information on the patient, and that the data are deleted at the end of the analysis, according to the experts.

IBM Watson Health says Watson for Oncology (separate from the Watson for Genomics) includes access to 29 million abstracts looking for 13 cancer types, 

according to some of its latest data sheets

. Watson for Oncology’s capabilities include the ability to read 200 million pages in a mere three seconds, according to the company.

The IBM Watson Health team also reportedly debuted 22 new scientific studies at the American Society for Clinical Oncology annual meeting in Chicago, back in May.  

™ in a statement that the process of getting AI into precision cancer medicine is exacting — and is not overnight.

"Adopting AI into healthcare takes time and scientific rigor — we are working closely with hundreds of hospitals and health systems around the globe to bring our oncology and genomics offerings to physicians and patients.”

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, our hosts Tom Castles and Jack Murtha talk FHIR (pronounced “fire”) with the CEO of HL7, Chuck Jaffe, Ph.D., M.D.

The Fast Healthcare Interoperability Resources (FHIR) is a draft standard created by the non-profit Health Level Seven International (HL7). It’s intended to further interoperability in healthcare. Founded in 2014, it has incrementally brought together millions of records, and continues to do so, even now.

FHIR has been expanding, especially recently, according to Jaffe’s recent conversation with

“This is growing over at least the last year and a half so that organizations and health systems around the world have leveraged the FHIR platform until it drives interoperability,” said Jaffe. “I suspect that the mass of institutions and entities that have enabled FHIR will have to grow once that mass has been achieved. I think the ability to reduce the barriers to interoperability will accelerate.”

The FHIR Accelerator program was launched, and it recently began incorporating the 

Gravity Project and its social determinants of health (SDOH) into the mix of digital variables

But the real hurdles that remain to true interoperability are not technological, Jaffe said.

“Policy always trumps technology, and we'll find that regulation, inertia and other concerns will continue to be a barrier toward thorough interoperable data exchange,” he said. “The key that is so important in our community is being able to understand what the words and concepts mean. And that development is accelerating in parallel to the data exchange environment in which FHIR is now expanding its use and capability.”

Take the temperature of FHIR. Check out the fifth episode of the fourth season of your favorite digital healthcare podcast, above, or on iTunes.

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This week’s guest: Chuck Jaffe, Ph.D., M.D., the CEO of HL7.

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President Donald Trump signs AI executive order in Oval Office in February 2019. (Courtesy of the White House)

Nearly $1 billion in artificial intelligence (AI) research funding was announced by the White House this week.

The request for non-defense AI funding coincided with an AI summit hosted by the Trump Administration, featuring two healthcare-specific “case studies” of how the future use of American AI is implemented.

“Today, we focus our attention on how all of these pillars of our American AI Initiative can also drive transformation within the federal government itself,” said Michael Kratsios, the chief technology officer of the United States. “Initiatives in AI R&D, data, and workforce can all enhance the way government functions and delivers services.”

 includes $202.5 million for the National Institutes of Health (NIH), the second largest total. (The largest is the National Science Foundation, at $487.6 million). Mentioned in the NIH goals are research project grants, and specifically mHealth programs for low- or middle- income countries.

Also included are Agency for Healthcare Research and Quality (AHRQ) programs including learning health systems grants, health IT safety grants, consumer IT grants for patient-facing technologies, clinical-decision support tools, and a patient-reported outcome initiative (based on the use of Fast Healthcare Interoperability Resource standards).

The summit featured two healthcare case studies in the use of AI from the NIH and from the Department of Health and Human Services (HHS).

Patricia Flatley Brennan, Ph.D., R.N., the director of the National Library of Medicine, spoke about the use of natural language processing at NIH. The AI technology saves time in the grant application referral process, she said. Additionally, AI and machine learning can automate indexing for PubMed.

Charles Keckler, J.D., the associate deputy secretary of HHS, presented how the use of AI can identify and cut “outdated, burdensome, and duplicative regulations, with the potential of greatly reducing human workload in a highly labor-intensive process,” according to 

“The Department of Health and Human Services is using artificial intelligence to analyze outdated, burdensome, and duplicative regulations—allowing us to more effectively cut the red tape holding our nation back,” added Kratsios, in his remarks.

The summit also included a panel featuring Ivanka Trump, advisor to the president, and Margaret Weichert, the deputy director for Management at the Office of Management and Budget and Acting Director of the Office of Personnel Management.

Breakout sessions followed, including federal agencies ranging from the Department of Homeland Security, the Department of Labor, the Department of Justice, and the National Science Foundation, among others.

The nearly $1 billion is not enough to keep pace with the investments of China and other countries, 

Trump signed an executive order in February which created the “American AI Initiative” with a stated goal of “protecting our AI advantage.”

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Earmarks include healthcare programs at NIH and AHRQ.

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A Florida hospital has agreed to pay and adopt a corrective action plan in response to allegations of its failing to provide timely access to patient records under HIPAA, according to the U.S. Department of Health and Human Services (HHS).

Bayfront Health St. Petersburg has paid $85,000 to the HHS Office for Civil Rights (OCR), and adopted the new internal rules to guarantee future rights of access for patients, 

The settlement is the first of its kind under 

an OCR initiative announced earlier this year

 to “vigorously enforce the rights of patients to receive copies of their medical records promptly and without being overcharged.”

The complaint came from a mother who had requested access to the medical records about her unborn child.

The woman had requested fetal heart monitor records from Bayfront starting in October 2017. The woman’s attorney further requested the records in January and February, 2018. An incomplete set of the records was given in March 2018, with a complete response provided to the lawyers the following August.

But the complete fetal heart records were only given over directly to the woman in February 2019, as a result of the OCR investigation.

Then federal agency said that HIPAA rules generally require providers to provide medical records within 30 days of the request — and also require providers to charge only a reasonable cost-based fee.

The corrective action plan requires Bayfront to develop written access policies and procedures to provide records quicker in following federal guidelines — and also to provide training and notice of those policies and procedures to employees.

OCR will also monitor Bayfront’s progress for one year, according to the settlement.

“We aim to hold the healthcare industry accountable for ignoring peoples’ rights to access their medical record and those of their kids,” said Roger Severino, J.D., the OCR director.

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Bayfront Health St. Petersburg Pays $85,000 to Office for Civil Rights.

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knew about allegations of data manipulation

 in one of its pending drug approvals before the U.S. Food and Drug Administration (FDA) took final action in May. It was only after the drug received the federal okay that the pharmaceutical giant told the federal regulator of the scientific problems.

, the head of the company pledged transparency in such situations in the future — even as he contended Novartis did nothing wrong in the 30-plus working days the company investigated internally the testing of Zolgensma.

“Going forward, though, we’ve learned from this,” said Vas Narasimhan, M.D., the Novartis CEO, during the webcast of the London meeting. “What we’ve decided to do is voluntarily and proactively taken a pledge with the FDA to ensure that we will inform them within five business days of any credible allegation of a data integrity issue of a filing in the Novartis group.”

The data manipulation involved trials using mouse cage cards, according to Narasimhan.

The company believes the data issues arose prior to Novartis acquiring AveXis, the subsidiary that developed Zolgensma, he added.

Safety, efficacy, and quality were not affected in the data changes, the CEO said at the Monday meeting.

Action had been taken against “those individuals we believe are responsible,” Narasimhan added.  

The full investigation took more than 30 working days — and the results have been laid out in a FDA Form 483 inspection document, which has not yet been made public, according to the CEO.

Despite the data manipulation, both Novartis and federal regulators are in support of keeping the treatment on the market.

Zolgensma, approved by the FDA in May, is generally described as the “most expensive” treatment currently offered. A single dose of the gene therapy costs over $2 million. It treats a rare inherited condition called spinal muscular atrophy (SMA), which is caused by mutations in the survival motor neuron 1 gene, which impacts muscle control and is a leading cause of infant mortality. Varying degrees of SMA affect approximately 1 in 11,000 babies each year, according to the advocacy group Cure SMA.

However, the FDA said last month that the pharma giant’s actions leave potential legal recourse open.

“We are also aware that AveXis (the Novartis subsidiary) became aware of the issue of the data manipulation that created inaccuracies in their (biologics license application) before the FDA approved the product, yet did not inform the FDA until after the product was approved,” said Peter Marks, M.D., Ph.D., the director of the Center for Biologics Evaluations and Research. “The agency will use its full authorities to take action, if appropriate, which may include civil or criminal penalties.”

Immediately after the Zolgensma data manipulation was revealed, Novartis stock dipped. But within a week, the Swiss pharma giant’s price had recovered. Later reports indicated that a Novartis insider 

sold nearly $1 million of shares just weeks before the Zolgensma allegations were made public

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Burnout is one of the factors feeding into the projected physician shortage looming over the next decade-plus. The American Medical Association (AMA) has put together a new initiative with a collection of support resources to try and keep doctors working and productive.

The “Practice Transformation Initiative”

 announced last week aims to assist doctors — immediately, according to the AMA.

“While AMA efforts to date have increased awareness of the physician burnout crisis at all levels and drive positive change, there is an immediate need for transformational solutions,” said Jesse M. Ehrenfeld, M.D., MPH, the AMA board chair. “The Practice Transformation Initiative is positioned to lead the medical community to activate systematic change that will energize physicians in their life’s work of caring for patients.”

The collaboration involves the Physicians Foundation, and an initial cohort of the Medical Society of New Jersey, the North Carolina Medical Society, and the Washington State Medical Association.

Those state groups, in turn, will recruit hospitals and practices into the Initiative, according to the AMA.

Included are online resources and modules, like the STEPS Forward online program which includes more than 50 tools that aim to manage stress, prevent burnout, and improve efficiency; and institutional assessments to determine burnout rates at the system-wide level.

An online resource for debunking regulatory myths, and also for demonstrating the challenges with electronic health records (EHRs) are also included through the site 

 — a partnership between the AMA and the MedStar Health National Center for Human Factors in Healthcare.

The AMA will also run a “Joy in Medicine” Recognition Program for people and organizations effectively pushing back on burnout.

The Collaborative for Healing and Renewal in Medicine, or CHARM, Charter is seeking signatures to promote doctor well-being, according to the group.

The Initiative also includes an event in two weeks. The American Conference on Physician Health will be held in Charlotte, N.C. from Sept. 19 to 21. The hosts will be the AMA, the Mayo Clinic, and Stanford Medicine.

The goal, the AMA says, is to further the research and understanding of solutions to burnout — and not just to the understanding of the phenomenon alone, according to the officials.

“Wide-spanning change in the healthcare delivery system needs to emphasize physician well-being as essential to achieving national health goals,” said Ehrenfeld.

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Program includes September conference, online assessments, resources.

AMA Practice Transformation Initiative Takes Aim at Burnout

The American market for electronic health records (EHRs) has been saturated to the point that the largest vendors are seeking out untapped and emerging international buyers, according to a new survey.

The biggest vendors, such as Allscripts and Epic Systems, are seeking out places such as Europe, Australia, the Middle East and Asia, according to Black Book Research’s Annual State of Global EHR Research.

“Because the U.S. is forecast to be one of the slowest-growing EHR markets over the next five years as it approaches saturation in the acute market, the largest system vendors are shifting their efforts to international expansion,” said Doug Brown, the president of Black Book. “Therefore, vendors such as Meditech, Epic Systems, Cerner and Allscripts are heating up into highly competitive international emerging markets.”

The biggest pushes: Allscripts into the United Kingdom, Australia, Canada and New Zealand; and Epic Systems’ increased shares in Middle East and Southeast Asia, according to the report.

The look included 68 EHR vendors, evaluating their reach in 12 regions across the globe, which included exaptation evaluations, forecast budget costs, and time and resource allocation goals.

Without uniformity in the IT systems in many of the countries, the market possibilities are broadened for the major EHR companies, according to the report.

“One exception being Germany that implemented, in 2018, a nationwide network that enables the secure data transmission among healthcare providers, connecting over 2.5 million healthcare professionals to 80 million citizens,” said Brown.

Another case study within the report: the IC Card of Taiwan. The “Integrated Circuit” card holds the medical data of some 99% of the nation’s 23 million citizens since its inception in 2005. But there is a catch, said Brown.

“Although simple and groundbreaking, the problem with the IC Card is that the information it holds is limited to the last six medical visits, prescriptions, allergies, organ donation willingness, and vaccinations,” he said.

The 10,000 participants in the survey included over 4,000 actual users of the EHRs, and also more than 6,800 individuals involved int e vendor selection process.

The survey time period extended over the first three quarters of 2019.

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Artificial intelligence (AI), machine learning, and revolutionary conclusions from population-level insights produced by fast and accurate new electronic tools.

Much of the digital health space can indeed be considered “glamorous.”

But what of the grunt work — the work of achieving interoperability, making all the tools work together so researchers can reach those splashy breakthroughs? What of the toil in the trenches of terabytes, coordinating deals and cooperation between agencies and hospitals, and writing the code which will make all the machines speak the same language, using standards that everyone can agree to?

That may be considered the less glamorous part of the job.

In this latest episode of the Data Book podcast, our hosts Tom Castles and Jack Murtha frame a discussion with Mona Siddiqui, M.D., MPH, the chief data officer of the U.S. Department of Health and Human Services.

Siddiqui said the work she does has a crucial role in making some of the headline-grabbing developments possible.

It might be “the hard thing” — but the challenge is worth it, she said.

“When I was asked to take on this role, I had a very clear sense of what I wanted to do, which is the not-glamorous part of the job,” she said. “People don’t want to work on creating a foundation and an institutional infrastructure that enables the use of data, people want to go on the data analytics, and people want to work on AI, and you know, all of the sort of the buzzword pieces—but nobody wants to create the hard thing, which is how do you connect the data?”

Check out the fourth episode of the fourth season, above, or on iTunes or wherever else you find your podcasts.

Podcasts

In the latest episode, our hosts speak with the chief data officer of HHS Mona Siddiqui, M.D., MPH.

Data Book Podcast: The 'Not Glamorous' Part of the Job

The Electronic Health Record Association (EHRA), representing the EHR industry, voiced its support for a proposed Medicare rule aligning e-prescribing standards with those used for prior authorization in Medicare Part D.

But the industry groups are asking federal regulators to delay the implementation until two years after the publication of the final rules — and they’re also requesting the Centers for Medicare & Medicaid Services make all the standards more uniform.

“The EHR Association understands that some states are pursuing different standards for electronic prior authorization,” the organization wrote in 

, on behalf of its 32 member companies. “We recommend that CMS work with states to align on common standards, in order to reduce redundant development and maintenance efforts for the same capabilities.”

The group, in commenting on version 2017071 of the National Council for Prescription Drug Programs SCRIPT Standard, also recommended the prevailing federal health privacy law be updated, additionally.

“To further align prior authorization for e-prescribing across other federal programs, we recommend that HIPAA be updated to reference the same standards, with the aim of upgrading any subsequent standards in concert,” they write.

, saying it would improve patients’ access to medications through the updates to the prior-authorization process, through ensuring security while expediting the prior authorizations. Prescribers would be able to complete such prior authorization online, typically in real-time—and even before a prescription is transmitted to a pharmacy.

“This proposed rule would reduce the time it takes for a patient to receive needed medications and ease the prescriber burden by giving clinicians the flexibility and choice to complete prior authorization transactions electronically,” said Seema Verma, MPH, the CMS administrator, in a statement at the time.

The EHRA said it would ask the changing standards over the next 24 months take account of the improving technologies the industry is bringing to market, they added.

“While the EHR Association supports the use of the NCPDP SCRIPT 2017071 standard for electronic prior authorization for prescriptions under Medicare Part D, we note the various current and candidate standards being used, particularly as HL78 FHIR is playing an increasing role in web-based APIs that enable real-time interactions using more current technology,” the Association wrote. “These technologies are not sufficiently mature, but efforts by HL7, DA Vinci, NCPDP, and X12 should be looked at for future direction in this space.”

Comments come in response to proposed rule for Medicare e-prescribing, prior authorization.