Precision Medicine
Electronic Health Records
Seqster's aggregation allows for improved care now, as well as the ability to pass on Alzheimer's care data to future generations of the family, opening up invaluable resources to the research community.
Precision Medicine
Along with the incredible promise of personalized care and prevention programs the challenges ahead are steep with a range of speakers to cover these and other pressing topics at our upcoming event.
Precision Medicine
To help understand the challenges of precision medicine, we're calling on our community to share their ideas and lessons learned during the #PrecisionHIT Twitter Chat on April 19.
Electronic Health Records
The health system will collect unprocessed data from AncestryDNA, MyHeritage and 23andMe to validate new findings and discover new mutations, the organization said.
Electronic Health Records
The MyHealthEData Initiative, announced by CMS' Seema Verma at HIMSS18, is too light on detail to make much of a difference, said the former VP – who offered his own way forward.
Analytics
Research team finds patterns of symptoms that might be caused by an underlying genetic variant.
Electronic Health Records
The C should stand for connected, not comprehensive, say tech, policy and clinical experts at the school's Center for Digital Health Innovation.
Compliance
The Securities and Exchange Commission has charged Elizabeth Holmes, founder and CEO of scandal-ridden startup Theranos, with “massive fraud.”
Along with former Theranos President Ramesh “Sunny” Balwani, Holmes has been charged with raising over $700 million from investors “through an elaborate, years-long fraud in which they exaggerated or made false statements about the company’s technology, business and financial performance.”
SEC alleges that Theranos, Holmes and Balwani deceived investors by making it appear as if they’d “successfully developed a commercially-ready portable blood analyzer that could perform a full range of laboratory tests from a small sample of blood,” according to the filing.
Not only did Holmes and Balwani make false statements to the media about their technology, they hosted misleading tech demonstrations and overstated “the extent of Theranos’ relationships with commercial partners and government entities, to whom they had also made misrepresentations.”
Theranos was once seen as a promising clinical lab startup, even inking a deal with Practice Fusion in 2015. Holmes could be seen in major magazines and was widely considered a top innovator.
But by March 2016, reports emerged over differing lab results from Quest and LabCorp that impacted patient care. And Wall Street Journal investigations over five years called into question the accuracy of Theranos’ tests.
While the company said it was addressing those deficient lab results and suspending testing, SEC soon launched its own investigation into Theranos and a class action lawsuit was filed shortly after.
By July, Congress was demanding answers from Holmes, including how she intended to remedy those flawed test results.
Holmes settled with one of the startup’s largest investors Partner Fund Management in May 2017, giving away her shares to some of the “most significant shareholders” as part of the settlement.
As for the SEC filing, Holmes has agreed to resolve the charges against her and the company, and, in addition to a $500,000 fine, Holmes will give up majority voting control over Theranos.
Holmes has also been barred as serving as an officer or director of a public company for 10 years and must return the remaining 18.9 million shares she obtained during the fraud. Further, if Theranos is acquired or liquidated, Holmes can’t profit from her ownership until she returns the $750 million to investors and other shareholders.
Holmes and Theranos did not admit or deny the SEC claims, according to officials. Balwani will face litigation by the SEC in federal district court in the Northern District of California.
“The Theranos story is an important lesson for Silicon Valley,” Jina Choi, SEC San Francisco Regional Office director said in a statement. “Innovators who seek to revolutionize and disrupt an industry must tell investors the truth about what their technology can do today, not just what they hope it might do someday.”
Steven Peikin, SEC Enforcement Division’s co-director added that “the charges make clear that there is no exemption from the anti-fraud provisions of the federal securities laws simply because a company is non-public, development-stage or the subject of exuberant media attention.”
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Theranos Holmes Suit 2018 (PDF)
Theranos Holmes Suit 2018 (Text)
Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com
Patient Engagement
Mayo Clinic and IBM Watson Health have announced the results of a cutting-edge project putting the supercomputer to work for patient matching: Watson brought in more patients than before to participate in recent breast cancer clinical trials.
Only 5 percent of patients with cancers participate in clinical trials nationwide, according to Mayo Clinic officials, who noted that that low enrollment makes for many clinical trials that are slow to finish or not completed. That delays advances in research and results in less access to better therapies.
[Also: Next-up for EHRs: Vendors adding artificial intelligence into the workflow]
What’s more, matching and enrolling patients in appropriate trials has proven to be a time-consuming, manual process.
“Novel solutions are necessary to address this unmet clinical need, advance cancer research and treatments, and, in turn, improve the health outcomes of patients,” Tufia Haddad, MD, a Mayo Clinic oncologist, said in a statement.
Watson for Clinical Trials Matching is programmed to accurately and consistently match patients to clinical trials for which they might be eligible, so that healthcare providers and patients can consider appropriate trials as part of a care plan.
Mayo Clinic implemented the system in July 2016 in its ambulatory practice for patients with breast cancer. In the 11 months after implementation, there was about an 80 percent increase in enrollment to Mayo’s systemic therapy clinical trials for breast cancer. Also, the time to screen an individual patient for clinical trial matches was lower when compared with traditional manual methods.
“This has enabled all patients to be screened for all available clinical trial opportunities,” Haddad noted.
Based on the initial testing phase, Mayo and IBM agreed to continue developing the system to include trials for other types of cancer and aspects of cancer care beyond medical therapies, such as surgery, radiation and supportive care.
Watson is programmed to support clinical trial matching for breast, lung and gastrointestinal cancers, and training on trials for additional cancer types is underway.
Twitter: @Bernie_HITN
Email the writer: bernie.monegain@himssmedia.com
Analytics
Nevada Governor Brian Sandoval will invite an additional 40,000 Nevadans on March 15 to enroll in the study and have their DNA sequenced for in-depth research.