Monday, June 3, 2013
San Antonio’s Innovative Medical Startups
By ANDREW MOORE
Reporter with Silicon Hills News
San Antonio’s medical technology industry can spur innovation and lead to new jobs in the local economy.
The Texas Technology Development Center (T3DC) hopes to encourage that by focusing on research, entrepreneurship and investment.
“Of all things, innovation is the single greatest economic driver in any economy,” said T3DC President Randall Goldsmith during the organization’s second quarterly luncheon. “What we bring here today is an example of what we are doing in San Antonio to grow our economy.”
The invitation-only luncheon attracted 200 people to get an update on the latest medical technology in San Antonio.
At the event, Cory Hallem, executive director with the University of Texas at San Antonio’s Center for Innovation and Technology Entrepreneurship, explained how his organization helps students get real entrepreneurship experience and even start their own companies.
“It’s really adding on to that education side through experiences, research, and support,” said Hallem. “How do you put a process in place that helps unlock the inner entrepreneur in someone who hasn’t done it before?”
The center helps students unlock their potential in a number of ways. They have a Technology Entrepreneur Boot Camp twice a year that teaches students how to start a tech company in a single day. CITE also holds the biannual $100,000 Student Technology Venture Competition – the largest undergraduate competition in the country. Additionally, the center has a Graduate Certificate in Technology Entrepreneurship and Management program for students involved in research. The program trains Ph.D. students how to launch a tech company in concurrence with their technology research. UTSA actively pairs students who wish to produce a viable product prototype with faculty and mentors that can help them accomplish their goals.
According to Hallem, UTSA now has over 100 active companies created by students and faculty. In the last three years, UTSA student startups have raised of $1 million in startup funding. One of the student companies has even been offered a tryout for the ABC show Shark Tank.
The second presenter, Lapara Medical, was born in the CITE program and won CITE’s $100,000 Student Technology Venture Competition last November. The startup is developing a laparoscopic cooling device to solve a problem present in kidney transplants and kidney tumor removal – called a nephrectomy.
“This problem stems from partial nephrectomies, where they go in and remove the tumor while leaving the rest of the kidney functioning,” said CEO Duncan Hughes. “They have to clamp the artery to that kidney. Doing so cuts off oxygen flow to that kidney and effectively gives the surgeon 30 minutes to perform the surgery.”
After 30 minutes, the kidney starts to die due to lack of blood flow. If the surgery cannot be completed in this time – and 75 percent of such surgeries cannot – the surgeon must cut the patient open and actually place ice packs around the kidney to keep it alive.
Lapara Medical is developing a laparoscopic cooling system that can be inserted into the body through four small incisions. The device will cool the entire kidney to exactly 15 degrees Celsius, which guarantees the surgeon up to two hours and 30 minutes to complete the surgery without needing to open up the patient. This approach reduces the risk of infection and complications, and greatly reduces a patient’s pain and required hospital stay after the operation.
“We are able to go in and actually change how a surgery is done and really bring change to this market,” said Hughes.
The startup’s cooling device will also be used for kidney transplants and can be adapted to other organs as well. The startup plans to turn their focus on liver surgeries and transplants in the near future.
Lapara Medical is seeking $270,000 in seed round funding to finish developing their prototype and entering into the first phases of testing. Hughes predicts the company will be worth around $300 million within five to seven years of operation.
The final presenter was San Antonio startup Cardiovate. Created by UTSA biomedical engineering Ph.D. graduate Jordan Kaufmann, Cardiovate has created an intravascular tissue regeneration stent graph for aneurism repair.
Aneurysms are an abnormal widening of a blood vessel due weaknesses in the vessel’s wall. If the blood vessel bursts, severe hemorrhage can occur. Aneurysms are often treated by a surgical procedure which inserts a stent graph inside the artery to reinforce the walls and prevents the blood vessel from ballooning. As the patient ages, these graphs move or leak – requiring the patient to have additional surgeries or causing the patient harm if not detected.
“No one wants to have as second surgery, so we looked at this as a problem we could address,” said CTO and President Jordan Kaufmann. “There are currently no tissue repairing stint graphs on the market. At this point, we will be the first one to enter.”
The new stint graph Cardiovate has developed is microscopically engineered to grow into the cells of the artery and create a lasting tissue that will not move or leak. Over time, the graft material is actually absorbed by the body, leaving only the sealing tissue in the reinforced artery. Because the tissue is flexible and adapts to changes in the body, patients should not need additional surgeries.
Kaufmann created Cardiovate with the support of UTSA College of Engineering Dean Mauli Agrawal, and UT Health Science Center Division Chief Steven Bailey. Cardiovate won last year’s University of Texas Horizon Fund Student Investment Competition which came with a seed funding check for $50,000. Agrawal and Bailey have joined Coffman as founders and contributed another $10,000 to the startup.
Cardiovate is currently looking to raise $700,000 for their seed stage of funding and has recently moved to the UTSA incubator for more lab work. The startup plans to ultimately merge with or be acquired by leading competitors Medtronic or Cook Medical.
Reporter with Silicon Hills News
San Antonio’s medical technology industry can spur innovation and lead to new jobs in the local economy.
The Texas Technology Development Center (T3DC) hopes to encourage that by focusing on research, entrepreneurship and investment.
“Of all things, innovation is the single greatest economic driver in any economy,” said T3DC President Randall Goldsmith during the organization’s second quarterly luncheon. “What we bring here today is an example of what we are doing in San Antonio to grow our economy.”
The invitation-only luncheon attracted 200 people to get an update on the latest medical technology in San Antonio.
At the event, Cory Hallem, executive director with the University of Texas at San Antonio’s Center for Innovation and Technology Entrepreneurship, explained how his organization helps students get real entrepreneurship experience and even start their own companies.
“It’s really adding on to that education side through experiences, research, and support,” said Hallem. “How do you put a process in place that helps unlock the inner entrepreneur in someone who hasn’t done it before?”
The center helps students unlock their potential in a number of ways. They have a Technology Entrepreneur Boot Camp twice a year that teaches students how to start a tech company in a single day. CITE also holds the biannual $100,000 Student Technology Venture Competition – the largest undergraduate competition in the country. Additionally, the center has a Graduate Certificate in Technology Entrepreneurship and Management program for students involved in research. The program trains Ph.D. students how to launch a tech company in concurrence with their technology research. UTSA actively pairs students who wish to produce a viable product prototype with faculty and mentors that can help them accomplish their goals.
According to Hallem, UTSA now has over 100 active companies created by students and faculty. In the last three years, UTSA student startups have raised of $1 million in startup funding. One of the student companies has even been offered a tryout for the ABC show Shark Tank.
The second presenter, Lapara Medical, was born in the CITE program and won CITE’s $100,000 Student Technology Venture Competition last November. The startup is developing a laparoscopic cooling device to solve a problem present in kidney transplants and kidney tumor removal – called a nephrectomy.
“This problem stems from partial nephrectomies, where they go in and remove the tumor while leaving the rest of the kidney functioning,” said CEO Duncan Hughes. “They have to clamp the artery to that kidney. Doing so cuts off oxygen flow to that kidney and effectively gives the surgeon 30 minutes to perform the surgery.”
After 30 minutes, the kidney starts to die due to lack of blood flow. If the surgery cannot be completed in this time – and 75 percent of such surgeries cannot – the surgeon must cut the patient open and actually place ice packs around the kidney to keep it alive.
Lapara Medical is developing a laparoscopic cooling system that can be inserted into the body through four small incisions. The device will cool the entire kidney to exactly 15 degrees Celsius, which guarantees the surgeon up to two hours and 30 minutes to complete the surgery without needing to open up the patient. This approach reduces the risk of infection and complications, and greatly reduces a patient’s pain and required hospital stay after the operation.
“We are able to go in and actually change how a surgery is done and really bring change to this market,” said Hughes.
The startup’s cooling device will also be used for kidney transplants and can be adapted to other organs as well. The startup plans to turn their focus on liver surgeries and transplants in the near future.
Lapara Medical is seeking $270,000 in seed round funding to finish developing their prototype and entering into the first phases of testing. Hughes predicts the company will be worth around $300 million within five to seven years of operation.
The final presenter was San Antonio startup Cardiovate. Created by UTSA biomedical engineering Ph.D. graduate Jordan Kaufmann, Cardiovate has created an intravascular tissue regeneration stent graph for aneurism repair.
Aneurysms are an abnormal widening of a blood vessel due weaknesses in the vessel’s wall. If the blood vessel bursts, severe hemorrhage can occur. Aneurysms are often treated by a surgical procedure which inserts a stent graph inside the artery to reinforce the walls and prevents the blood vessel from ballooning. As the patient ages, these graphs move or leak – requiring the patient to have additional surgeries or causing the patient harm if not detected.
“No one wants to have as second surgery, so we looked at this as a problem we could address,” said CTO and President Jordan Kaufmann. “There are currently no tissue repairing stint graphs on the market. At this point, we will be the first one to enter.”
The new stint graph Cardiovate has developed is microscopically engineered to grow into the cells of the artery and create a lasting tissue that will not move or leak. Over time, the graft material is actually absorbed by the body, leaving only the sealing tissue in the reinforced artery. Because the tissue is flexible and adapts to changes in the body, patients should not need additional surgeries.
Kaufmann created Cardiovate with the support of UTSA College of Engineering Dean Mauli Agrawal, and UT Health Science Center Division Chief Steven Bailey. Cardiovate won last year’s University of Texas Horizon Fund Student Investment Competition which came with a seed funding check for $50,000. Agrawal and Bailey have joined Coffman as founders and contributed another $10,000 to the startup.
Cardiovate is currently looking to raise $700,000 for their seed stage of funding and has recently moved to the UTSA incubator for more lab work. The startup plans to ultimately merge with or be acquired by leading competitors Medtronic or Cook Medical.
Costa Rica makes strides in innovation
By Mario Garita for Infosurhoy.com
Thanks to an effective partnership between the public and private sectors, Costa Rica has emerged as Central America’s innovation leader.
Last year, service sector exports, which include call centers, shared services, medical technology, information services and entertainment and digital technologies, were higher (US$5.560 billion) than agricultural exports (US$4.064 billion) for the first time, according to the Foreign Trade Corporation of Costa Rica (PROCOMER).
“These results reflect the positive impact of world-class companies on corporate sector practices and the impact of innovation policies on research and development capabilities,” Minister of Foreign Trade Anabel González said. “We have a good foundation to continue developing and diversifying based on innovation.”
The INSEAD (European Institute of Business Administration) Global Innovation Index 2012ranked Costa Rica first in Central America and third in the region, behind Chile (39) and Brazil (58). Costa Rica ranked 60th out of 141 countries worldwide.
“This shows Costa Rica has achieved success [by getting] multinational companies to establish themselves in the country and domestic companies to integrate themselves into chains with global value,” González added.
In 2012, PROCOMER created the Market Place website, designed to increase and facilitate trade for small and medium-sized companies and to develop local industries in the service sector.
Upon registering on Market Place, Costa Rican entrepreneurs can find foreign customers.
“This tool also generates other benefits, such as knowledge and technology transfers, higher technical skills and quality, the promotion of international certifications and more added value for exports,” said PROCOMER’s Value Chain Director for Exports, Rolando Dobles.
An example is Electroplast, a company that has been producing plastics since 1985 and today employs 100 workers.
As a result of initiatives by PROCOMER, the Ministry of Foreign Trade and the Costa Rican Coalition for Development Initiatives (CINDE), Electroplast, which specializes in high-precision injection molding, now supplies large, multinational companies.
“This step allowed us to sell to a multinational company for the first time in 2012,” said Óscar Ramírez, Electroplast’s owner.
Electroplast exports 99% of its products, with more than half of its production directed to the medical devices sector. The company has experienced an annual average sales increase of 10%.
CINDE also attracts foreign investment in Costa Rican’s technology sector by attending and organizing international forums such as the Life Sciences Forum Costa Rica, which took place in March.
The forum brought together more than 400 representatives from leading companies in the medical industry, suppliers and international experts from Latin America, United States, Puerto Rico and Italy.
Since authorities started efforts to position Costa Rica internationally in 1984, 51 multinational companies, including six of the 20 leading companies of manufacturing technology in the medical sector, have established offices in the country.
“In the past five years alone, more than 25 new companies in the manufacturing sector of high-tech medical devices have established offices in Costa Rica, and exports [have doubled],” said Gabriela Llobet, CINDE’s general director. “This allows us to visualize a very dynamic landscape for the next few years.”
The country’s geographical location and high educational level of the population are determining factors why companies choose Costa Rica over other countries, according to a study by EvaluateMedTech for CINDE.
Costa Rica’s educational system ranks 23th in the world and tops Latin America, according to the Global Competitiveness Report 2011-2012 of the World Economic Forum.
“Today, we compete directly with countries with very strong industry throughout the world, such as India, Poland, Ireland and Malaysia,” Llobet said. “We also have a number of competitors in the region that we have significantly exceeded.”
Recently, Volcano Corp. – a company that manufactures medical devices – chose Costa Rica for its first plant outside the United States, investing more US$40 million, according to CINDE.
“After entering the Costa Rican market with long-term expectations, we can take advantage of the qualified talent in the country and its proximity to the United States, enabling us to significantly increase our production rate,” said David Sheehan, the company’s chief operating officer.
Celgene Announces Launch of "Innovation Impact" Awards to Recognize Excellence in Creative Patient,
by Business Wirevia The Motley Fool May 31st 2013 8:48AM
Celgene Announces Launch of "Innovation Impact" Awards to Recognize Excellence in Creative Patient, Caregiver or Healthcare Provider Programs
Deadline for Applications is July 31 st , 2013;
Submissions Accepted Online Only at www.innovationimpact.com
SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NAS: CELG) , announced today the initiation of the "Innovation Impact" Awards to recognize effective, innovative and successful initiatives in one of two therapeutic areas: hematology or oncology. The program aims to recognize the achievements of US-based not-for-profit organizations addressing the needs of patients, caregivers and healthcare providers in today's challenging healthcare environment.
"The Innovation Impact Awards represent an opportunity to highlight initiatives that have had a demonstrable impact on the lives of patients, families, caregivers and/or the medical professionals who provide treatment and care," said Joel Beetsch, Vice President, Patient Advocacy at Celgene. "One of Celgene's goals with the Innovation Impact Awards is to ensure that the selected programs have an opportunity to flourish and evolve. That's why we're asking participants to share plans on how they plan to build on their success and take their program to the next level."
Applications are now being accepted. Submissions must demonstrate inspired innovation, a validated need, proven impact, measurable results and show how it will build on its current success. An independent judging panel comprised of innovation, healthcare and advocacy experts will select two winners; one in oncology and one in hematology.
Winners will be announced by October 15, 2013 and each winner will receive a $100,000 monetary award. Award winners will be invited to participate in an exclusive day-long "Innovation Experience" that will feature a workshop led by an innovation expert.
Applications are restricted to patient and professional organizations and associations with an interest in hematology or oncology. Organizations must be classified as a not-for-profit and headquartered in the United States. Consideration for awards will not be given to individuals, medical facilities or research institutions. Nor will applications be accepted for pre-clinical, clinical or translational research programs. Each organization may submit only one entry.
For more information visit http://www.innovationimpact.com to learn more about our Awards program, including: the evaluation criteria, experts serving on our judging panel, frequently asked questions, and terms and conditions for the Awards.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.
For more information, please visit the Company's website at www.celgene.com.
The article Celgene Announces Launch of "Innovation Impact" Awards to Recognize Excellence in Creative Patient, Caregiver or Healthcare Provider Programs originally appeared on Fool.com.
Celgene Announces Launch of "Innovation Impact" Awards to Recognize Excellence in Creative Patient, Caregiver or Healthcare Provider Programs
Deadline for Applications is July 31 st , 2013;
Submissions Accepted Online Only at www.innovationimpact.com
SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NAS: CELG) , announced today the initiation of the "Innovation Impact" Awards to recognize effective, innovative and successful initiatives in one of two therapeutic areas: hematology or oncology. The program aims to recognize the achievements of US-based not-for-profit organizations addressing the needs of patients, caregivers and healthcare providers in today's challenging healthcare environment.
"The Innovation Impact Awards represent an opportunity to highlight initiatives that have had a demonstrable impact on the lives of patients, families, caregivers and/or the medical professionals who provide treatment and care," said Joel Beetsch, Vice President, Patient Advocacy at Celgene. "One of Celgene's goals with the Innovation Impact Awards is to ensure that the selected programs have an opportunity to flourish and evolve. That's why we're asking participants to share plans on how they plan to build on their success and take their program to the next level."
Applications are now being accepted. Submissions must demonstrate inspired innovation, a validated need, proven impact, measurable results and show how it will build on its current success. An independent judging panel comprised of innovation, healthcare and advocacy experts will select two winners; one in oncology and one in hematology.
Winners will be announced by October 15, 2013 and each winner will receive a $100,000 monetary award. Award winners will be invited to participate in an exclusive day-long "Innovation Experience" that will feature a workshop led by an innovation expert.
Applications are restricted to patient and professional organizations and associations with an interest in hematology or oncology. Organizations must be classified as a not-for-profit and headquartered in the United States. Consideration for awards will not be given to individuals, medical facilities or research institutions. Nor will applications be accepted for pre-clinical, clinical or translational research programs. Each organization may submit only one entry.
For more information visit http://www.innovationimpact.com to learn more about our Awards program, including: the evaluation criteria, experts serving on our judging panel, frequently asked questions, and terms and conditions for the Awards.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.
For more information, please visit the Company's website at www.celgene.com.
The article Celgene Announces Launch of "Innovation Impact" Awards to Recognize Excellence in Creative Patient, Caregiver or Healthcare Provider Programs originally appeared on Fool.com.
AHIMA: Hospitals lag on ICD-10 planning, steering committees
Author Name Jennifer Bresnick | Date June 3, 2013
When AHIMA is worried, hospitals should be, too. A new survey by the American Health Information Management Association and vendor TrustHCS reveals that hospitals are still struggling to get off the ground when it comes to ICD-10 implementation less than two years before the mandated conversion date. More than 50% of the 293 healthcare facilities surveyed in the fall of 2012 admitted that they were still in the beginning stages of planning for ICD-10, and 25% hadn’t even appointed an ICD-10 steering committee to head the project.
Teaching community hospitals and academic medical centers fared slightly better than the average, with 30% reporting that they regularly met with their ICD-10 steering committee and were moving through their project plans at an acceptable pace, as opposed to only 17% of other types of hospitals with a plan underway. Critical access hospitals (CAHs) were the slowest to begin ICD-10 conversion, with the survey’s authors concluding that their exception from DRG-based reimbursement was the likely culprit.
“The move to ICD-10 is a long assembly line requiring a monumental amount of teamwork and coordination,” say Torrey Barnhouse and William Rudman, PhD, RHIA, writing for AHIMA. “Once organizational buy-in is achieved, rapid action with quarterly auditing of progress is a must.” Buy-in is likely to be stymied by the increased financial burden that ICD-10 will place on hospitals, including funding for coder education. While the survey found that 72% of hospitals have begun their education programs, it also noted that the cost of these programs averaged$12,200 per coder, with academic medical centers spending closer to $27,000 per staff member.
“Budgets for ICD-10 training are higher within groups who have already established committees and have transition projects underway,” the study notes. “The researchers behind the study believe this finding indicates that deeper and more extensive ICD-10 education is certainly required by many providers.” This may come as unwelcome news to budget committees who will be asked for more funding as the true need for financial support reveals itself. The cost for undertraining will be even higher, however, if claims are denied and revenue streams encounter roadblocks due to poorly coded documentation or ICD-10 mistakes.
Medical coders with ICD-10 experience will have the luxury of choosing from numerous job offers in the next few years as hospitals widely expect to increase their coding staff to mitigate potential dips in productivity. Sixty-three percent of respondents plan to hire new coders, and 25% plan to outsource their coding needs to staffers working at an hourly rate. Computer assisted coding (CAC) will supplement the effort in more than three quarters of hospitals, but human experience will be in increasingly high demand.
“This year is a crucial time for organizations to make progress on ICD-10,” Barnhouse and Rudman conclude. “With half of the nation’s hospitals still in the beginning stages, according to the 2012 survey, HIM professionals must dig deeper and push harder to entrench themselves in the implementation process. More than ever, communication and planning are the key factors to a successful transition.”
http://ehrintelligence.com/2013/06/03/ahima-hospitals-lag-on-icd-10-planning-steering-committees/
http://ehrintelligence.com/2013/06/03/ahima-hospitals-lag-on-icd-10-planning-steering-committees/
One of Medicare's most-wanted fugitives is arrested in L.A.
One of Medicare's most-wanted fugitives, a former clinic owner in the Los Angeles area, was arrested on his return from South Korea, authorities said.
Federal investigators said Won Suk Lee, 44, was taken into custody Saturday at Los Angeles International Airport.
Authorities said Lee was an acupuncturist and owner of two medical clinics in Huntington Park who billed Medicare for $2.1 million in false claims and got paid about $1.2 million.
“Since launching our most wanted list in February 2011, we’ve caught 41 fugitives,” said Steve Ryan, assistant special agent in charge in Los Angeles for the U.S. Department of Health and Human Services' inspector general. “Our Office of Inspector General fugitive operations are worldwide, with one of our senior agents stationed full time at Interpol to coordinate international investigations.”
Lee fled to South Korea after an arrest warrant was issued last year, according to Ryan. From 2009 to 2011, he said, Lee used a physical therapy clinic as a front to bill for services, such as acupuncture and massage, that are not covered by Medicare.
Lee couldn't be reached for comment.
There are still about 170 fugitives on the Medicare most-wanted list.
Federal officials have been trying to crack down on fraud and abuse in Medicare and other public healthcare programs to recover some of the billions of dollars lost annually.
To better combat fraud, the government has established special strike force teams in cities such as Los Angeles, Miami and Houston.
http://touch.latimes.com/#section/-1/article/p2p-76142939/
http://touch.latimes.com/#section/-1/article/p2p-76142939/
Wearable technology will be as disruptive as mobile, Kleiner Perkins partner predicts
Posted: 05/29/2013 01:19:52 PM PDT
Updated: 05/29/2013 03:25:29 PM PDT
SAN FRANCISCO -- Wearable computing is emerging as the type of significant technology shift that will drive innovation in the way personal computing did in the 1980s or mobile computing and tablets are doing currently, said Kleiner Perkins Caufield & Byers partner Mary Meeker at the All Things D conference on Wednesday.
While technology cycles generally last 10 years, she said wearables were coming on stronger and faster than is typical. The change is noteworthy because major technology cycles often support tenfold growth in users and devices, she said in her annual report on the state of the Internet.
Pebble Technology Pebble Watch
"Some people laugh at wearables..." read one slide featuring an image from the TV show "Saturday Night Live" that mockedGoogle (GOOG) Glass, a wearable technology. As the audience chuckled, she brought up the next slide, reading "Some people laughed at PC & Internet." The slide showed a 1999 Barron's cover trumpeting the headline "Amazon.Bomb."
Later in the morning, Twitter CEO Dick Costolo picked up the theme, telling conference goers that it was clear wearable technology would play a large role in the future, even if what is perhaps the most-discussed example -- Google Glass -- doesn't emerge as the first mainstream hit.
Speaking last night at the conference, Apple (AAPL) CEO Tim Cook stopped short of clarifying if Apple was working on wearable products amid speculation that it is developing a smartwatch, saying only that wearable computers had to be compelling. He added that Google's Glass is likely to have only limited appeal.
Meeker also reviewed themes she has highlighted in the past, including the remarkable growth of mobile technology and the Chinese economy, and the ceding of power from traditional personal computing companies to phone and tablet makers.
The FDA launches first inquiry into medical iPhone
May 29, 2013 5:04 PM
The Food and Drug Administration (FDA) this week launched its first investigation into an unregulated mobile medical app.
Medical diagnosis on-the-go offers a new opportunity for health entrepreneurs. But the FDA believes that patient safety is potentially at risk with some — but not all — of these apps. The agency has said that it wants stricter rules to govern these apps and devices.
The FDA’s final guidance on mobile medical apps, when it comes, is expected to resolve some of the uncertainty that plagues health entrepreneurs who aren’t clear whether their app should be regulated.
“What is unclear [is] how many of these companies — representing almost 40,000 apps — would fall under selective enforcement by the FDA,” said Malay Gandhi, chief strategy officer for health accelerator Rock Health.
The FDA’s letter was sent to Biosense Technologies Private Ltd., an Indian company with an app called uChek, which is designed to work alongside commercially available urinalysis test pads, also known as “dipsticks.” A typical application for dipsticks is to test for urinary tract infections.
The app gets to work when you take a photo of a test strip (already FDA approved and made by Siemens AG and Bayer AG) with an iPhone camera. The technology can identify the concentrations of certain substances in those strips, and will deliver results to patients.
The FDA’s letter to the makers of uChek is intended to serve as a warning to other developers with unregulated apps used in clinical settings. There are thousands of apps in the App Store that fall in the medical category.
“We intend to work very closely with the U.S. FDA over the coming months to ensure that we continue to deliver accurate, affordable and convenient diagnostics across the world,” Abhishek Sen, co-founder of Thane, India-based Biosense, said in an email statement to the media.
Read more at http://venturebeat.com/2013/05/29/the-fda-launches-first-inquiry-into-medical-iphone-app/#3WlhcCE4uSAzqWvf.99
A journey into the potential of big medical data
By John Gonzales | May 29, 2013
My colleagues and I embarked on a data pilgrimage last week -- the good ships of Southwest Airlines standing in for the Nina, Pinta and Santa Maria. Our destination: the Healthy Communities Data Summit in the cyber frontier of San Francisco.
But before you sound the nerd alert, or hokey analogy alert, consider some of the enlightened comments that came from data experts who were just as aware of the limitations of their groundbreaking work as they were of its potential.
“We understand our applications are useful and important, but they are not going to be the end for systemic problems,” said Rebecca Ackerman, a fellow at the nonprofit Code for America.
The organization is comprised of web geeks, city experts and tech industry leaders working to harness local government information systems for the good of the community.
Still, what Ackerman and several other panelists were getting at was the way in which data can provide powerful insight into what drives systematic and social- based medical problems. But how information alone cannot solve those problems.
As John Kim, a co-director at the Advancement Project put it; data is often “painting the lines on the field” but not winning the game.
That’s not to say that identifying troubling medical trends is not the precursor to solving them. Kim’s presentation on behalf of the public policy change organization he helps direct underscored hospital shortages in communities that needed them the most.
Hospitals have shuttered in poor, mostly minority communities for decades, and a data map sharply revealed this dearth of medical care around our city centers.
And in some cases, the collection of data is uniquely positioned to track health behaviors in real time.
Asthmapolis is an application that uses asthma inhaler sensors and advanced analytics to identify patients who need help controlling the disease. It also identifies places where attacks are frequent. Using the app, asthma attack hotspots could be pinpointed down to a given apartment building.
Mark Gehring, president and co-founder of Asthmapolis, based in Madison, WI., said asthma suffers who participate often “get our report and learn for the first time that they are not controlled.”
“We should be able to predict in the future that a given community has a certain asthma risk,” he said.
Note: The Healthy Communities Data Summit was sponsored by the California HealthCare Foundation, which also funds the Center for Health Reporting. Center for Health Reporting staff and editors attended the Summit as independent journalists seeking information and sources on the cutting-edge use of medical data.
Federal judge lifts ban on public access to Medicare data
(Reuters) - A federal judge lifted a 33-year-old injunction barring public access to a confidential database of Medicare insurance claims, a decision that could lead to greater scrutiny of how physicians treat patients and charge for their services.
Judge Marcia Morales Howard ruled Friday in favor of a motion by DowJones, publisher of the Wall Street Journal, that the U.S. District Court for the Middle District of Florida lift an injunction imposed in 1979.
The American Medical Association had fought lifting the ban, arguing that disclosure of the information would violate physicians' right to privacy. Doctors had successfully made the same argument in 1979, when a judge ruled the release of such information would violate the 1974 Privacy Act.
The AMA suggested Friday that it might appeal the decision. In a statement, AMA President-elect Ardis Dee Hoven said the doctors lobby was "considering its options on how best to continue to defend the personal privacy interests of all physicians."
Officials at the Centers for Medicare and Medicaid Services couldn't be reached for comment. A Dow Jones spokeswoman declined to comment.
Dow Jones went to court in January 2011, attempting to overturn the injunction after a series of stories in the Journal found tens of millions of dollars in fraud and other abuse by doctors and other Medicare providers. Medicare is funded by U.S. taxpayers.
The Journal's work, however, was restricted by limitations placed on the data released by the U.S. Department of Health and Human Services, which rendered anonymous all information pertaining to individual Medicare providers. That meant reporters weren't allowed to name individual doctors who the Journal identified solely through using the data.
In her ruling, Judge Howard said that because judicial rulings in the years since the injunction have restricted the Privacy Act's reach, the ban was based "upon a legal principle that can no longer be sustained."
When the suit was filed, the Journal's editor-in-chief at the time, Robert Thomson, said: "The Medicare system is funded by taxpayers, and yet taxpayers are blocked from seeing how their money is spent. It is in the interest of law-abiding practitioners that those who are gaming the system are exposed."
Dow Jones is a unit of News Corp.
(Edited by Michael Williams)
NHS To Come Under Data Protection Spotlight, Warns Business Consultants
NHS trusts will come under the spotlight as Data Protection regulations undergo significant changes in order to protect sensitive patient information, Shropshire business consultants have warned.
Mark Harris and Jason Perry, of The Business Company.
Private companies are subject to compulsory ICO audits under the Data Protection Act unlike the NHS where data audits are currently only consensual.
Consultants from The Business Company, near Shrewsbury, said that could soon change following a consultation paper which could see them move to the Clinical Commissioning Group model.
Mark Harris, managing director of the consultancy firm, said: “The Information Commissioner can come in and audit a private company for data protection and check they have the correct framework and sufficient controls in place at any time.
“However, this is not the case with the NHS. As a public body the ICO can only request an audit, often these requests are made as a result of patient complaints or data protection breaches meaning this type of audit request is more about remediation activity rather than the more desired preventative approach seen with compulsory audits.
“The NHS historically does not have a great track record in terms of Data Protection compliance.
“Couple this with the fact the NHS is now going through some of the most radical changes in its history which will see unprecedented volumes of patient data being transferred, then it is clear that the ICO see the NHS as a major risk in terms of compliance.”
Jason Perry, a partner at The Business Company, who specialises in data protection frameworks, said the Caldicott Guardians and Heads of Information and Governance within NHS trusts and newly formed Clinical Commissioning Groups would need to provide assurance to their Boards and to the public that they are meeting these compliance challenges head on.
He said it was particularly important as most of the reporting and internal audit conducted within the trusts were freely available on their websites for public consumption
“If the they do not have appropriate controls and procedures in place they could be fined significant sums of money – we have seen a recent case where the trust was fined £329,000.
“If the they do not have appropriate controls and procedures in place they could be fined significant sums of money – we have seen a recent case where the trust was fined £329,000.
“When you also consider that these newly formed groups will be selecting services not only based on cost but compliance there could be an even higher price to pay,” Mr Perry added.
Mr Harris said other care professionals such as care homes, dental practices and GP practices, would also come under the spotlight in the potential change of regulation and should “get ahead of the curve”.
“This is under consultation until the end of May and then every NHS service could be in the spotlight.
“As a regulatory compliance organisation, we believe it is always better to confront compliance head on rather than wait for the ICO to conduct an audit and publish the findings by which time it could be too late,” he said.
“We will be offering a virtual compliance programme to the NHS sector to ensure they have assurance in meeting the regulations.
“We will be working with a number of other professional partners in Shropshire and the West Midlands to ensure that data held by NHS services is fully protected.
“This could have a huge impact on the NHS across the UK and we will be working alongside them to ensure it has minimal impact and cost.”