Validic, a provider of health data solutions for remote monitoring and virtual engagement, today announced it has received the ISO/IEC 27001: 2013 security certification. The certification follows a rigorous third-party auditing process and underscores Validic’s dedication to maintaining the most comprehensive, industry-leading data security standards.
As the incidence of data breaches increases both in frequency and severity, it is critical that organizations handling sensitive data have secure, validated Information Security Management Systems (ISMS) in place. In securing the ISO 27001 certification, Validic has proven its capabilities in maintaining the most secure standards and environments for personal health and lifestyle data.
Importance of ISO 27001 certification
ISO 27001 “specifies the requirements for establishing, implementing, maintaining and continually improving an information security management system within the context of the organization,” and is one of the most well-known and recognized international standards for information security management.
Why It Matters
Requirements for ISO 27001 include proven data privacy standards, systems access control, and third-party security vetting. As Validic continues to expand its data science and connectivity capabilities, this certification ensures adherence to industry-leading security standards – protecting the four million connected lives Validic supports and the billions of data transactions Validic manages each month.
In addition to possessing the ISO 27001 certification, Validic also maintains a HIPAA-compliant, GDPR-compliant platform and its data center is SAS 70 Type II certified and SSAE16 (SOC2) compliant. The organization cultivates a culture focused on data security and privacy, and continues to expand the rigorous standards which it applies in regard to data security.
A new medical device is showing that it may be possible to improve and even reverse cognitive decline in those with Alzheimer’s disease, all without drugs and with little noticeable side effects.
The MemorEM system from NeuroEM Therapeutics, a company based in Phoenix, Arizona, delivers transcranial electromagnetic treatment, or TEMT, to the brains of patients in two one-hour sessions each day for two months. This involves propagating electromagnetic waves toward β-amyloid aggregates that seem to be responsible for the symptoms of Alzheimer’s. In animal studies, it was shown that TEMT does indeed prevent β-amyloid aggregates from forming and even disrupts existing conglomerations.
In a study on eight patients who went through the regimen described above, all but one showed either a pause or reversal in cognitive decline, a remarkable achievement for a non-drug therapy. There doesn’t seem to be substantial side effects, so larger studies will hopefully commence soon.
CarePass – often considered CVS Health’s response to Amazon Prime – offers a number of benefits including free one or two day delivery on most prescription medications and purchases, a discount on items under the CVS Health brand, access to a 24/7 pharmacist hotline and a $10 monthly store credit that can be used on select items.
Pharmacists on the company’s hotline are on hand to help answer questions about a customer’s medication and refer out to additional tools or services.
Membership to CarePass costs $5 a month or a discounted $48 annual fee and also offers free one or two day delivery for eligible purchases of CVS.com. To qualify for CarePass benefits, members must already have signed up for the company’s customer loyalty ExtraCare Rewards Card.
CarePass members are also provided additional discounts on CVS Health brand items which include over-the-counter medications, vitamins and supplements and can be used in retail stores and online. CVS also promises to roll out additional healthcare related perks like a complimentary sports physical as it looks to continue to build out its healthcare delivery services.
Alongside initiatives like CarePass, CVS Health has been steadily building out its national network of HealthHUBs, which are part of the pharmacy chain’s initiative to leverage its wide geographic distribution as a new front door to the healthcare system in the wake of the company’s blockbuster acquisition of Aetna last year.
Recently, the company also announced plans to boost its direct-to-consumer telehealth offering by making it available in 26 states and Washington, D.C. Enabled through a partnership, the $59 telehealth visits are available to patients two years and older who are matched with a board-certified health care provider.
The company initially piloted CarePass in the Boston Area and said the program was able to drive a 15 to 20 percent increase in customer purchases while also appealing to a wide array of customers. In the company’s test markets 20 percent of CarePass members were millennials.
“We are thrilled to expand CarePass nationally, bringing simplified value to our customer while making it easier for them to care for themselves and their families,” CVS Pharmacy President Kevin Hourican said in a statement.
“Initial customer response has exceeded our expectations with members utilizing the program’s full benefits and becoming more engaged across all of our digital offerings.”TrendMD v2.4.3
Two new approvals, more than 1,000 clinical trials underway and nearly $5 billion raised.
Those are just some of the highlights from the second quarter of 2019, according to the latest quarterly report from the Alliance for Regenerative Medicine, which the organization released Thursday. The data were compiled from 932 companies involved in gene therapy, cell therapy, tissue engineering and other areas of regenerative medicine.
Companies involved in gene and cell therapies and other regenerative medicine areas raised $4.8 billion during the first half of the year, including $2.6 billion in the second quarter. However, that was down from the more than $4.1 billion that they raised in the second quarter of 2018, which itself represented a 164 percent increase from the same period in 2017. However, companies in Europe and Israel saw an increase in fundraising, with this $1.3 billion figure for the first half of 2019 representing a 17 percent increase over the same period last year.
For comparison, a report that the Silicon Valley Bank released earlier this month, which looked at healthcare and biopharma more broadly, found that venture capital fundraising by biopharma startups this year would likely fall behind the figure for 2018, while remaining ahead of 2017. Healthcare companies generally have raised $5.8 billion so far this year, compared with $9.6 billion for all of 2018 and $9.1 billion in 2017.
Still, the ARM report showed a significant increase in the number of regenerative medicine clinical trials happening this year, with 1,069 underway in Phase I, Phase II and Phase III – compared with 977 in the second quarter of last year. Phase III studies include 30 in gene therapy, 16 in gene-modified cell therapy, 32 in cell therapy and 16 in tissue engineering.
Meanwhile, two new gene therapies received regulatory approval, in the U.S. as well as in Europe.
In May, the Food and Drug Administration approved Novartis’ Zolgensma (onasemnogene abeparvovec-xioi) for spinal muscular atrophy in children younger than 2. Although the company turned heads when Novartis gave it a list price of more than $2 million, the non-profit Institute for Clinical and Economic Review deemed it cost-effective given that it is a potentially curative therapy.
And in March, the European Medicines Agency approved bluebird bio’s Zynteglo (autologous CD34-positive cells encoding beta-AT87Q-globin gene) for the treatment of the blood disorder beta-thalassemia.TrendMD v2.4.3
In diabetes, Medtronic’s efforts in machine learning and artificial intelligence has been well documented with its joint launch with IBM of the virtual diabetes assistant Sugar.IQ. The company’s MiniMed 670g hybrid closed-loop insulin pump also comes loaded with the Guardian 3 sensor, which uses artificial intelligence to help diabetes patients beat high and low blood glucose-related events.
Now, the Dublin-based medical device giant is aiming to leverage AI in another business: stroke care. Last week, Medtronic announced that it has entered into a global distribution agreement with Viz.ai, whose artificial intelligence-powered imaging software is aimed at quickly treating patients suspected of having ischemic strokes. Viz.ai, based in San Francisco, received FDA’s de novo clearance for its clinical decision support software for stroke back in February 2018. The company is pursuing regulatory go-aheads in other countries.
In an interview this week, Stacey Pugh, vice president of Medtronic Neurovascular, explained that Viz.ai’s software can mean all the difference between a good and a bad medical outcome for a stroke patient with a large-vessel occlusion (LVO). Here’s what the software platform connected to CT scanners is capable of doing: the AI can quickly determine based on a CT scan of the patient’s brain, whether the patient has suffered a large-vessel occlusion, flag where it believes that occlusion has occurred and notify doctors.
“When you look at a scan of perfusion in the brain, there will be a certain amount of areas of perfusion you should expect to see, and this software through AI shows a segment of perfusion is missing, and that’s because the software has flagged it,” Pugh said in a phone interview. “It does this automatically before the scan can be read by a PACS [Picture Archiving and Communication System] and a radiologist looks at it.”
This saves valuable time in a health event where time is of the essence. Per Medtronic’s announcement, a Viz.ai study in “two centers showed that in 95.5 percent of true positive cases, its technology alerted the stroke specialist earlier than the standard of care, saving an average of 52 minutes.”
“We know from all of the research that’s been done that even by moving care up by half an hour in a large-vessel occlusion, you can meaningfully impact outcomes,” Pugh said. “So gaining minutes is a very meaningful outcome.”
Consider the standard protocols today per Pugh where the patient arrives at a hospital that may not be a comprehensive stroke center and the doctor orders CT scans of the brain. Then, the radiologist reads the scan and sends the information to the physician who ordered the scan. Thereafter, the physician reviews the scan and radiological reports and sends the information to the receiving physician at the comprehensive stroke center. This process can take some time and meanwhile the patient is “losing about 1.9 million neurons per minute that you have an LVO in the brain,” Pugh said.
Viz.ai’s system cuts down these steps improving the chances for a better outcome, she said. But there is another advantage. This software is especially valuable at hospitals that may lack stroke expertise.
“These stroke cases get messed up a lot of times at these smaller hospitals,” Pugh said. “You don’t have physicians who are looking at these kinds of scans all the time and so it’s not just about speed, it’s about detecting cases which otherwise wouldn’t be detected.”
The Viz.ai app is able to alert physicians and display images of suspected large-vessel occlusions.
Perhaps equally importantly, the software platform can be preprogrammed to alert doctors about the potential LVO at both the smaller, local hospital where the patient first arrives and the comprehensive stroke care center where the patient will be ultimately treated.
So you have speed and accuracy built into the system and the ability to get everyone on the stroke care team on the same page simultaneously, Pugh said.
Th other capability of the Viz.ai system is communication. The HIPAA compliant, cloud-based application allows doctors on the Viz.ai system to not only view the brain perfusion images of the patient suspected of having a large-vessel occlusion on their smartphones but also to communicate with each other through the app thereby streamlining care.
Even comprehensive stroke centers can benefit from the Viz.ai system because of its ability to flag potential trouble areas, Pugh said.
While the terms of Medtronic’s global distribution agreement with Viz.ai was not disclosed, Pugh said that the software can be sold both as standalone and as part of a bundle with Medtronic’s stroke hardware products. They include the Solitaire stent retriever, guidewires and other products that allow surgeons to remove the clot in the brain.
Viz.ai was founded in 2016, according to Crunchbase by Dr. Chris Mansi, David Golan and Manoj Ramchandran. Mansi is a neurosurgeon and the CEO of the company. The company raised $21 million in a Series A funding round in July 2018 that Kleiner Perkins led and in which GV (formerly Google Ventures) participated.
At the time, a Kleiner investor who joined Viz.ai’s board commented:
“We were attracted not only to the technology behind Viz.ai and its impact on patient outcomes, but also its adoption model. Many new health-tech solutions struggle to gain traction because they are an outside-in sale to medical teams, requiring changes to procedures and workflows. In contrast, physicians and their teams are driving adoption of the Viz.ai platform because it is not disruptive to emergency room procedures and fits naturally into existing systems,” said Mamoon Hamid, General Partner, Kleiner Perkins.
In other words, disruptive technologies can be more easily adopted as long as they do not cause disruption in the general, English sense of the term.
The partnership with Medtronic is further proof that the largest pure-play medical device company believes that more in the stroke market are likely to buy into Viz.ai’s product and vision.TrendMD v2.4.3
A blood test to detect early brain changes in Alzheimer’s disease has moved one step closer to clinical use, researchers report.
Up to two decades before people develop the characteristic memory loss and confusion of Alzheimer’s disease, damaging clumps of protein start to build up in their brains.
Researchers say they can measure levels of the Alzheimer’s protein amyloid beta in the blood and use such levels to predict whether the protein has accumulated in the brain.
The blood test may even be more sensitive than the gold standard—a PET brain scan.
When blood amyloid levels are combined with two other major Alzheimer’s risk factors—age and the presence of the genetic variant APOE4—the test can identify people with early Alzheimer’s brain changes with 94% accuracy, the study shows.
The findings, which appear in the journal Neurology, represent another step toward a blood test to identify people on track to develop Alzheimer’s before symptoms arise. Surprisingly, the test may be even more sensitive than the gold standard—a PET brain scan—at detecting the beginnings of amyloid deposition in the brain.
Early screening
Such a test may become available at doctors’ offices within a few years, but its benefits will be much greater once there are treatments to halt the disease process and forestall dementia.
The difficulty of identifying participants who have Alzheimer’s brain changes but no cognitive problems has hampered clinical trials of preventive drug candidates.
The new blood test could provide a way to efficiently screen for people with early signs of disease so they can participate in clinical trials evaluating whether drugs can prevent Alzheimer’s dementia.
“Right now we screen people for clinical trials with brain scans, which is time-consuming and expensive, and enrolling participants takes years,” says senior author Randall J. Bateman, professor of neurology at Washington University in St. Louis.
“But with a blood test, we could potentially screen thousands of people a month. That means we can more efficiently enroll participants in clinical trials, which will help us find treatments faster, and could have an enormous impact on the cost of the disease as well as the human suffering that goes with it.
Before it’s too late
The test, an earlier version of which first was reported two years ago, uses a technique called mass spectrometry to precisely measure the amounts of two forms of amyloid beta in the blood: amyloid beta 42 and amyloid beta 40. The ratio of the two forms goes down as the number of amyloid beta deposits in the brain goes up.
The current study involved 158 adults over age 50. All but 10 of the participants in the new study were cognitively normal, and each provided at least one blood sample and underwent one PET brain scan.
The researchers classified each blood sample and PET scan as amyloid positive or negative, and found that the blood test from each participant agreed with his or her PET scan 88 percent of the time—promising but not accurate enough for a clinical diagnostic test.
By the time people become forgetful, their brains are so severely damaged no therapy is likely to fully heal them.
In an effort to improve the test’s accuracy, the researchers incorporated several major risk factors for Alzheimer’s. Age is the largest known risk factor; after age 65, the chance of developing the disease doubles every five years. A genetic variant called APOE4 raises the risk of developing Alzheimer’s three- to fivefold. And gender also plays a role: Two out of three Alzheimer’s patients are women.
When the researchers included these risk factors in the analysis, they found that age and APOE4 status raised the accuracy of the blood test to 94%. Sex did not significantly affect the analysis.
“Sex did affect the amyloid beta ratio, but not enough to change whether people were classified as amyloid positive or amyloid negative, so including it didn’t improve the accuracy of the analysis,” says first author Suzanne Schindler, an assistant professor of neurology.
Further, scientists initially considered the results of some people’s blood tests false positives because the blood test was positive for amyloid beta but the brain scan came back negative. But some people with mismatched results tested positive on subsequent brain scans taken an average of four years later.
The finding suggests that, far from being wrong, the initial blood tests had flagged early signs of disease the gold-standard brain scan missed.
Slow and expensive
There is growing consensus among neurologists that Alzheimer’s treatment needs to begin as early as possible, ideally before any cognitive symptoms arise. By the time people become forgetful, their brains are so severely damaged no therapy is likely to fully heal them.
But testing preventive treatments requires screening thousands of healthy people to find a study population of people with amyloid build-up and no cognitive problems, a slow and expensive process.
As part of the study, the researchers analyzed the enrollment process for a prominent Alzheimer’s prevention trial called the A4 study that used PET scans to confirm the presence of early Alzheimer’s brain changes in potential participants. They concluded that prescreening with a blood test followed by a PET scan for confirmation would have reduced the number of PET scans needed by two thirds.
Unlike blood tests, which cost a few hundred dollars, each PET scan costs upward of $4,000. A single site can only run a few dozen PET brain scans a month, because PET scanners are primarily reserved for patient care, not research studies.
“If you want to screen an asymptomatic population for a prevention trial, you would have to screen, say, 10,000 people just to get 1,500 or 2,000 that would qualify,” Bateman says.
“Reducing the number of PET scans could enable us to conduct twice as many clinical trials for the same amount of time and money. It’s not the $4,000 per PET scan that we’re worried about. It’s the millions of patients that are suffering while we don’t have a treatment. If we can run these trials faster, that will get us closer to ending this disease.”
The National Institute on Aging of the National Institutes of Health, the National Institutes of Health, the Alzheimer’s Association, the Foundation for Barnes-Jewish Hospital, Willman Scholar Fund, Eli Lilly Co./Avid Radiopharmaceuticals, and an anonymous foundation funded the work.
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