Healthcare IT
As hospitals and doctors' offices throughout the country race to join online systems that enable them to share medical information securely, a new study proposes that these systems may already be reducing and cutting unnecessary care.
Based on new findings by University of Michigan researchers published online in the journal Medical Care, fewer emergency patients received second round medical scans when they were admitted to a hospital that partakes in a health information exchange, or HIE.
And although the study concentrates specifically on scans performed on patients who have gone through two different emergency departments in a 30-day period, the authors note that the findings serve as a good sample case for the effectiveness of HIEs. The study is one of the first of its kind to demonstrate, with concrete data that HIEs may provide the increased efficiency they pledge.
"The researchers chose to examine emergency care because emergency department teams need information quickly in order to diagnose and treat a patient," said senior author and U-M Medical School emergency physician, Keith Kocher, M.D.
"The ability to log in to a computer and pull up that patient's previous records from other hospitals through an HIE; instead of ordering duplicate tests or scans, holds great promise. But until now, large-scale studies haven't been done," he added.
The findings reveal that the use of repeat CT scans, chest X-rays, and ultrasound scans was considerably lower when patients had both their emergency visits at two different hospitals that participated in an HIE. The data comes from two large states that were among the early adopters of HIEs: California and Florida.
Patients were 59 percent less likely to have a superfluous CT scan, 44 percent less likely to get a duplicate ultrasound, and 67 percent less likely to have a repeated chest X-ray when both their emergency visits were at hospitals that shared information across an HIE.
Kocher worked with Eric Lammers, Ph.D., who performed the analysis for his doctoral work at the U-M School of Public Health and is now working at Mathematica Policy Research.
"The emergency department is an important test case for whether we would see any impact from HIEs on rates of repeat imaging. The fact that we find that there is a decrease is in and of itself significant." said Lammers.
The federal government has incentivized participation in HIEs, offering states grants to form them, and medical providers extra money if they sign on. In Michigan, several HIEs have emerged, and the two largest just announced plans to merge. HIEs are a key extension of the electronic health records that hospitals and practices are also being incentivized to adopt.
"There has been a lot of hope, and some hype, that these systems will enable more efficiency in how care is provided across unaffiliated providers," says Lammers. The availability of several years of data from various sources in two HIE early-adopter states gave the chance to do the study, he notes.
The researchers collected information from the California and Florida State Emergency Department Databases, from 2007 through 2010, and information on hospital HIE participation and affiliation from the Health Information Management Systems Society annual survey. The state ED databases were amassed as part of the Healthcare Cost and Utilization Project of the federal Agency for Healthcare Research and Quality.
All in all, they discovered that patients in the two states received 20,139 repeat CT scans, meaning that 14.7 percent of those who had a CT scan in their first emergency visit had another one at their second emergency visit at another, different hospital within a month.
Additionally there were also 13,060 repeat ultrasounds, which were planned for 21 percent of those who had had ultrasounds at their first visit, and 29,703 repeat chest X-rays, ordered for 19.5 percent of those who had an X-ray at their first emergency visit.
While the researchers couldn't exactly tell that doctors at the second emergency department had accessed the patient's records from the first ED, or that it influenced their decision-making if they did, the presence of an HIE at both hospitals means it would have been possible to do so. And they did note that the rates of repeat scanning were higher when an HIE was absent than when one was. They also projected that if applied nationwide, HIE could reduce health care costs by $19 million annually for these types of repeat imaging tests in the ED.
"Our data allowed us to study a very specific type of care where HIE was associated with reducing what would potentially be a redundant test by half, which we think is pretty meaningful. We can't say yet how generalizable these results will be to other settings, but these are definitely interesting empirical findings," said Kocher.
Kocher also notes that other types of patient records, such as recent lab test results, can also make a significant difference in what an emergency doctor chooses to do when presented with an emergency patient.
While Lammers notes that not all states report the pertinent data to the HCUP system, and that more broad reporting could make research on the impact of HIEs easier as the systems become more common nationwide. The data allows researchers to see the activity of individual patients across their different medical encounters, while preserving patient
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Healthcare IT News
Patients Likely to Benefit from Health Information Exchanges Between …
As hospitals and doctors' offices throughout the country race to join online systems that enable them to share medical information securely, a new study proposes that these systems may already be reducing and cutting unnecessary care.
Based on new findings by University of Michigan researchers published online in the journal Medical Care, fewer emergency patients received second round medical scans when they were admitted to a hospital that partakes in a health information exchange, or HIE.
And although the study concentrates specifically on scans performed on patients who have gone through two different emergency departments in a 30-day period, the authors note that the findings serve as a good sample case for the effectiveness of HIEs. The study is one of the first of its kind to demonstrate, with concrete data that HIEs may provide the increased efficiency they pledge.
"The researchers chose to examine emergency care because emergency department teams need information quickly in order to diagnose and treat a patient," said senior author and U-M Medical School emergency physician, Keith Kocher, M.D.
"The ability to log in to a computer and pull up that patient's previous records from other hospitals through an HIE; instead of ordering duplicate tests or scans, holds great promise. But until now, large-scale studies haven't been done," he added.
The findings reveal that the use of repeat CT scans, chest X-rays, and ultrasound scans was considerably lower when patients had both their emergency visits at two different hospitals that participated in an HIE. The data comes from two large states that were among the early adopters of HIEs: California and Florida.
Patients were 59 percent less likely to have a superfluous CT scan, 44 percent less likely to get a duplicate ultrasound, and 67 percent less likely to have a repeated chest X-ray when both their emergency visits were at hospitals that shared information across an HIE.
Kocher worked with Eric Lammers, Ph.D., who performed the analysis for his doctoral work at the U-M School of Public Health and is now working at Mathematica Policy Research.
"The emergency department is an important test case for whether we would see any impact from HIEs on rates of repeat imaging. The fact that we find that there is a decrease is in and of itself significant." said Lammers.
The federal government has incentivized participation in HIEs, offering states grants to form them, and medical providers extra money if they sign on. In Michigan, several HIEs have emerged, and the two largest just announced plans to merge. HIEs are a key extension of the electronic health records that hospitals and practices are also being incentivized to adopt.
"There has been a lot of hope, and some hype, that these systems will enable more efficiency in how care is provided across unaffiliated providers," says Lammers. The availability of several years of data from various sources in two HIE early-adopter states gave the chance to do the study, he notes.
The researchers collected information from the California and Florida State Emergency Department Databases, from 2007 through 2010, and information on hospital HIE participation and affiliation from the Health Information Management Systems Society annual survey. The state ED databases were amassed as part of the Healthcare Cost and Utilization Project of the federal Agency for Healthcare Research and Quality.
All in all, they discovered that patients in the two states received 20,139 repeat CT scans, meaning that 14.7 percent of those who had a CT scan in their first emergency visit had another one at their second emergency visit at another, different hospital within a month.
Additionally there were also 13,060 repeat ultrasounds, which were planned for 21 percent of those who had had ultrasounds at their first visit, and 29,703 repeat chest X-rays, ordered for 19.5 percent of those who had an X-ray at their first emergency visit.
While the researchers couldn't exactly tell that doctors at the second emergency department had accessed the patient's records from the first ED, or that it influenced their decision-making if they did, the presence of an HIE at both hospitals means it would have been possible to do so. And they did note that the rates of repeat scanning were higher when an HIE was absent than when one was. They also projected that if applied nationwide, HIE could reduce health care costs by $19 million annually for these types of repeat imaging tests in the ED.
"Our data allowed us to study a very specific type of care where HIE was associated with reducing what would potentially be a redundant test by half, which we think is pretty meaningful. We can't say yet how generalizable these results will be to other settings, but these are definitely interesting empirical findings," said Kocher.
Kocher also notes that other types of patient records, such as recent lab test results, can also make a significant difference in what an emergency doctor chooses to do when presented with an emergency patient.
While Lammers notes that not all states report the pertinent data to the HCUP system, and that more broad reporting could make research on the impact of HIEs easier as the systems become more common nationwide. The data allows researchers to see the activity of individual patients across their different medical encounters, while preserving patient
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Fewer Beds Lead to More Effective ICUs…
According to an opinion piece published in the Journal of the American Medical Association, fewer beds in intensive care units (ICUs) could help curb disparity in service use.
Intensive care accounts for around 3 percent of healthcare spending and almost 1 percent of gross domestic product (GDP), wrote Rebecca Gooch, M.D., of the University of Pittsburgh School of Medicine and Jeremy M. Kahn, M.D., of the University of Pittsburgh Graduate School of Public Health. However, in the United Kingdom, intensive care accounts for only 0.1 percent of GDP.
In the U.K., Gooch and Kahn wrote, there are only five ICU beds for every 100,000 people, and they are used almost exclusively for patients who are at a high risk for death. In the United States, however, there are 25 ICU beds for every 100,000 people and many ICU patients are admitted simply for observation.
"At the same time, compared with patients in the United Kingdom, substantially more patients in the United States die in the ICU, suggesting that increased bed availability appears to reduce the incentive to keep dying patients out of the ICU," they wrote.ICU BED
Gooch and Kahn link this correlation to the economic concept of demand elasticity, which is the notion that a product creates its own demand.
"Just as the creation of a new lane on the interstate highway can lead to increased traffic as new drivers seize the opportunity to travel on the larger road, new critical care beds can lead to increased use. As supply constraints are removed, clinicians are more likely to use the service, even for patients unlikely to benefit,” they wrote.
In an ideal setting, organizations would target ICU admissions for critically or seriously ill patients, who woustand the greatest chance of benefiting from ICU care, the authors suggest.
“With a reduced ICU bed supply, hospitals would have the incentive to keep patients who would benefit from care elsewhere, out of the ICU,” the
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EHRS Help Physicians Enhance Care…
A new study in the journal Health Services Research discovered that nearly three-quarters of physicians using electronic health records in 2011 said there were clinical benefits when patients' medical histories were kept in digital files. The study’s main focus was on doctors' perceptions of clinical benefits to patient care when EHRs were in use.
Chief of research and evaluation at the Office of the National Coordinator for Health Information Technology and lead author of the study, Jennifer King, explained in the article that physicians with more experience using EHRs were more likely to report clinical benefits.
Researchers examined and analyzed the responses from 3,180 physicians to the Physician Workflow Survey questionnaire about their experiences with EHRs.
"A majority of physicians said they were alerted to a potential medication error or critical lab value, and about one-third reported that EHRs helped them identify needed lab tests or facilitated direct communication with patients," said King.
The study’s findings may pave the way for new opportunities for more doctors to gain health IT benefits.
“Stage 2 of the Meaningful Use Program, which provides incentives from the Centers for Medicare & Medicaid Services for EHRs, includes policies designed to enhance the use of EHRs to exchange data between providers and give patients access to their health records,” said King.
“These policies may increase the rate at which physicians are able to use their EHRs to realize benefits such as not ordering duplicate lab tests and identifying needed tests," she added.
"The study reinforces our view that meaningful use of EHR technologies can deliver clinical benefits and improve outcomes," chair of the Electronic Health Record Association and senior director of strategy and operations for Siemens Healthcare, Mickey McGlynn , stated in a news release.
Moreover, McGlynn pointed out that the majority of care delivery in the U.S is provided in office settings with 10 or fewer physicians, and these environments have fewer resources to support health IT.
"Because of that, they have historically been late adopters of EHRs. Successful EHR adoption requires provider organization to integrate technology into their workflows and to adjust workflows over time to support their practices and specialties,” she said.
McGlynn added that the study could help those hesitant to invest in EHR technology to come to a realization that benefits may not be achieved on the spot, but rather over time.
"EHR adoption is a journey not a destination. All stakeholders must collaborate to ensure that requirements to achieve both benefits and incentives are practical and do not add unnecessary burdens to busy providers who must make patient care their top priority,” she said.
The results of the survey were reported by Health Behavior News Service, part of the Center for Advancing
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Medicade Expansion Increases ER Use…
According to a study published in Science, an increase in insured hospital patients due to Medicaid expansion made way toward a 40 percent increase in their visitations to the emergency room (ER).
Moreover, based on a Medicaid lottery program in Oregon, registration in Medicaid increased the probability of ER use by 7 percent, according to lead researcher Sarah Taubman of the National Bureau of Economic Research in Cambridge, Mass.
"These findings speak to one cost of expanding Medicaid, as well as its net effect on the efficiency of care delivered, and may thus be a useful input for informed decision-making balancing the costs and benefits of expanding Medicaid," Taubman and her team wrote.
The researchers divided emergency department visits based on time of day and whether or not they led to an admission. Around 90 percent were defined as outpatient emergency department visits and increased visits from Medicaid enrollees were "solely in outpatient visits."
Expansion of Medicaid connected with an increase in visits in all categories except those considered "emergent, nonpreventable." According to findings of the study, the greatest increase was among visits considered "primary care treatable" and "non-emergent.”
Additioanlly, the researchers noted several factors that limited the generalizability of the study, including the principally white and city-based population used for the study, the fact that signup for the study was voluntary, and the lack of follow-up study on patients' use of emergency services after 13 months.
"These limitations to generalizability notwithstanding, our study is able to make use of a randomized design that is rarely available in the evaluation of social insurance programs to estimate the causal effects of Medicaid on emergency department care. We find that expanding Medicaid coverage increases emergency department use across a broad range of visit types, including visits that may be most readily treatable in other outpatient settings,” the researchers
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Imaging Technology Could Help Solve Crimes via Corneal …
A UK team has discovered that modern high-resolution digital images are now so highly detailed, that they can enlarge the eyes in people's photos and retrieve images of out-of-shot bystanders reflected on their corneas.
Couple this with the fact
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Expensive Robotic Surgery on Colon Shows Little to No …
According to data submitted by researchers from Johns Hopkins University School of Medicine, patients who receive an elaborate robotic colon surgery are likely to experience the same success rate as those who undergo a minimally invasive laparoscopic surgery, however are subjected to paying a much heavier bill.
These recent findings have proffered a counter argument over the seemingly aggressive advertising some hospitals have applied in promoting the features and advantages of this new, expensive technology even before proper research was conducted to find out whether robotic surgery is actually more beneficial to patients.
"The true test of something new in medicine should be: Is it better? Is it safer? Does it save money? If not, then we probably shouldn't be using it. What we have found is that the robot is no better than laparoscopy and it costs more. It has no benefit," said associate professor of surgery and oncology at the Johns Hopkins University School of Medicine and leader of the study, Nita Ahuja, M.D.
The study has since gone on to be published online in the journal, JAMA Surgery.
Using the U.S. Nationwide Inpatient Sample database, Ahuja and her team analyzed data from 244,129 colectomies (surgery to remove part or all of the colon) between October 2008 and December 2010 performed at hospitals across the country. Based on data from the colectomies, the team found comparable complication rates, mortality rates, and length of hospital stays between laparoscopic surgery and robotic surgery. However, the robotic surgery cost an average of nearly $3,000 more ($14,847 vs. $11,966) than laparoscopic surgery.
Additionally, the study also compared results of open surgery. Open surgery was performed on 51.7 percent of patients, laparoscopy on 47.6 percent and robotic surgery in just 0.7 percent of cases. The study also found laparoscopy was linked with a lower mortality rate, complication rate, shorter hospital stays, and lower costs than open surgery.
Robotic surgery is performed by a surgeon who controls instruments inside the body via computer, usually from a room adjacent to the patient. Surgeons lose some of the physical feel they use to make certain judgments, but many say they gain a larger range of motion, as robotic arms and "hands" can do things that human arms and hands cannot. It is also easier to learn robotic surgery, notes Ahuja, who herself is a colorectal surgeon.
"The researchers say there may be some bias in who is chosen for which type of surgery; healthier and younger patients may be getting laparoscopic and robotic surgery, skewing the results somewhat. A randomized, controlled clinical trial comparing approaches head to head would be the best way to determine which one is truly the best," she said.
In the meantime, the surgical robot is growing in popularity for colon surgery, even though there is no concrete evidence that proves that it is in fact better and despite the new evidence showing that it is more expensive.
If the robot proved to have better advantages and benefits than basic colon surgery, then Ahuja would deem it a credible resource despite its steep price.
"Just because something sounds like it's good doesn't mean it is. We need to keep studying it before it becomes the standard of care without the supporting evidence," Ahuja
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Imaging Network Combines with Current EHRs and HIEs…
An enhanced interoperability system allows for healthcare organizations to securely exchange imaging data, thus increasing referrals, reducing costs, and honoring regulatory requirements.
Merge Healthcare, Inc. (Chicago, IL, USA) has recently released its novel invention, the iConnect Network, an advanced imaging network that enables hospitals, providers, and imaging centers to swap or exchange imaging information securely and electronically. This interoperability service, which incorporates with current electronic health record (EHR) networks and health information exchanges (HIE), facilitates has boosted referrals and provides meaningful use stage 2 (MU2) imaging requirements in an economic manner.
“It has been an exciting opportunity to test Merge’s new iConnect Network. This technology gives us a competitive advantage for both our providers and patients. Since Marana is a part of an accountable care organization [ACO] and is patient centered medical home certified, iConnect Network is a true example of a solution that integrates with our EHR, achieves information exchange and helps our health center be more efficient by automating time-consuming processes. This ultimately enables us to improve treatment times, reimbursements and patient care, as well as meet core regulatory requirements,” said chief information officer, Luis Velasco, at Marana Health Center (Marana, AZ, USA).
With MU2 as a key component for numerous healthcare organizations and physician EHR adoption rates constantly increasing, there is a growing need for hospitals and imaging centers to provide imaging data to all EHRs used by their provider community. Without any supplementary communications, iConnect Network enables providers to honor regulatory requirements and distribute vital patient data directly into a community physician’s EHR without having to build expensive point-to-point HL[health level]7 interfaces.
“We have prior experience with Merge’s iConnect Access solution, and we know the organization’s reputation for providing cost-effective technologies with little software involvement from IT [information technology] teams throughout implementation. We’ve received a lot of positive feedback from referring physicians, and we anticipate that this will be an exciting opportunity for them to provide faster treatments and, ultimately, improve patient care,” said chief information officer, Frederick Sachs, at Long Island Radiology (New York, NY, USA), one of the beta site customers who helped Merge with the release of iConnect Network.
Director of IT at Radiology, Ltd. (Tucson, AZ, USA), Merge’s second beta site customer for iConnect Network, Ron Cornett, enthusiastically agreed, stating: “The beauty of working with a platform like iConnect Network is the seamless integration with our referring physician base. Now we’re able to support our entire community of providers as they meet the demands of meaningful use as well as future technology and care initiatives.”
“We’re pleased that our customers see the value and financial opportunities associated with implementing iConnect Network,” said CEO of Merge Healthcare, Justin Dearborn.
“Not only are we enabling them to cost-effectively solve a real-world business problem, we are meeting the challenges that healthcare providers are facing with meaningful use and interoperability. We are dedicated to providing technologies that support value-based, collaborative care and will continue to innovate and expand the iConnect Network in the coming months with several phased roll outs,” he went on to add.
Further capabilities will be added to iConnect Network over time, including electronic patient referrals and online ordering processes, automated insurance precertification services for imaging centers and hospitals, and direct patient access to care navigation for scheduling and accessing images.
Merge’s enterprise and cloud-based solutions for image intensive specialties provide access to any image, anywhere, any time. Merge also provides clinical trials software and other health data and analytics solutions that engage consumers in their personal
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Improving MU for Radiology
…
Meaningful use (MU) guidelines usually cover points that are somewhat unrelated to radiology. Yet an editorial recently published in the November issue of Radiology suggests new guidelines and categories for health IT to drive the ultimate goal toward more effective at improving imaging.
According to authors Tara A. Morgan, MD, of the University of California-San Francisco, and colleagues, most radiologists are having difficulty incorporating MU criteria into their practices.
“As implementation of the meaningful use program continues and each new stage of regulation is updated and released, we believe that it is critical for radiologists and other specialists to play an active role in the development of meaningful use criteria that are applicable to their specialties,” they wrote.
The seven categories developed by the authors are tailored to positively benefit the quality of health care, increase efficiency and productivity, and apply specifically to the practice of radiology.
The criteria outlined by Morgan and colleagues include electronic image storage and display, information exchange between referring providers and radiologists, information exchange between health care institutions, patient engagement, clinical decision support for radiologists, clinical decision support for referring providers, and clinical quality measurement.
Below are the authors’ major supporting points for each category.
Electronic image storage and display
• PACS for image storage and display are crucial for radiologists’ efficiency and workflow.
Information exchange among radiologists and referring providers
• This exchange is critical for successful communication and workflow.
• Radiologists can send imaging reports to the EMR, leading to timely turnaround, rapid availability of imaging interpretation, and faster clinical decision making
• Electronic imaging requests can be received.
• Maintains the database for communication between referring providers and radiologists regarding unexpected findings necessitating a follow-up.
• Physicians can receive electronic reminders about patients recommended for follow-up imaging
• Clinical data can be imported and viewed to help develop protocols and imaging techniques.
Clinical decision support for referring providers
• Helps referring providers request the most appropriate radiologic exam.
• Clinical decision support software tools have pertinent clinical information that aids radiologists in creating protocols and interpreting exams.
• Information such as patient history, progress notes, vital signs, laboratory results, and medication lists assists in accurately interpreting images and ensuring that the clinical question is being addressed.
• Integrated access offers reliable and time-efficient information.
• Access to complete, multi-institutional imaging history reduces a patient’s cumulative radiation.
Patient engagement
• Involves patients in their own imaging health care through electronic means.
• Allows patients to schedule or cancel appointments, as well as view electronic images and reports.
• Could include electronic patient reminders to schedule non-routine, nonemergency imaging.
• Patient-mediated sharing of medical records between institutions would be efficient, saving time for those who are accustomed to electronic communication.
Clinical quality measurement
• Gives feedback and enables intervention and improvement for the timeliness of reporting, patient wait time, and communication between radiologists and referring providers.
• Could potentially track and measure percentages of unexpected clinical findings or imaging orders that contained relevant history and examination indication.
• Could improve workflow by measuring the wait time for outpatient scheduling and median patient wait time in the radiology department.
• Could enable positive intervention for a radiology practice.
“We hope that there will be some redirection of the meaningful use criteria in the upcoming revisions to the program so that the goal of a useful, portable, and secure electronic health records can be realized. We hope that continued advocacy with policy makers on behalf of radiologists will influence the meaningful use criteria as they pertain to the practice of radiology,” wrote Morgan and
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How Government Shutdown Restricts Impact of Health IT…
As of the today, the U.S. government remains no where near the possibility of ending the shutdown that has gripped the nation and has left over 800,000 federal employees unemployed since last Tuesday. And while the impact of the government shutdown on health IT hasn’t necessarily received prime importance or attention via media coverage, it is still important to note the affects taking place on health IT today and the toll it’s taking on both providers and patients.
For instance, the U.S. Department of Veterans Affairs said last week that the shutdown will reverse any progress it has made on cutting its much criticized backlog of disability claims.
As of the beginning of August, the backlog had been attached to 496,000 claims, from 611,000 claims in March. The longer this shutdown plays out, the longer veterans will go without answers about whether their care will be covered or not.
While the Centers for Medicare & Medicaid Services have said that it will continue to accept and process Meaningful Use attestations during the shutdown, such efforts will most definitely be limited and restricted with its labor force significantly reduced by more than 3,500 employees, which is even more bad news for providers.
"CMS is slow enough as it is, let along any prolonged interruption. If it is just a day or two, no big problem, but a week or more is going to spell chaos. The longer this shutdown lingers, the more rural providers like HCHC will continue to feel financially squeezed,” said FierceHealthIT Editorial Advisory Board member Stephen Stewart, CIO at Henry County Health Center in Mount Pleasant, Iowa.
The U.S. Department of Health & Human Services Office for Civil Rights, which is in charge of enforcing privacy and security rules outlined by the Health Insurance Portability and Accountability Act, has been reduced from 221 employees to five, two of whom are in charge of "orderly phase-down and suspension of operations." Therefore, the longer this shutdown continues, the less safe patients will feel about the privacy of their protected health information and medical records.
ONC has also had to push back all standards and interoperability scaffold activities, as well as all work related to privacy, security and clinical quality measurement, and administration of the Certified Health IT Product List. For many in congress already think that Meaningful Use processes are too slow and difficult, that the program is a "waste of taxpayer dollars" or that the government should re-evaluate the program. Again, the longer this shutdown prevails, the more health IT policy work remains dormant, only adding more wood to the fire for opponents of such efforts.
While health IT isn’t considered a heavyweight topic in mainstream media and in light of thousands of people currently unemployed, still it should not be ignored. Because the longer this shutdown lasts, the more difficult and painful it will be on providers and patients
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Rubbery Robots Could Lead to Safer, Cost-effective …
Based on a report by Scientific American, the effectiveness of robots during surgery is riddled with conflicting view points. Some praise the use of robots in surgery, especially during invasive surgeries, while others believe the rigidity and complexity of the tools offer little to no help. The latter argument has been mostly true, however a company based in Boston seeks to redefine the utilization of robots in surgery.
Soft Robotics, Inc., a Boston-based start-up company, is exploring the use of rubbery biomedical tools to enhance robotic surgery in order to help improve the field. The company is developing rubbery robots for use in surgery and other biomedical applications and is utilizing technology produced at Harvard University's Whitesides Research Group.
Spearheaded by renowned Harvard chemist and materials scientist, George Whitesides, who is also a member of Scientific American’s Board of Advisers and also serves as both a board member and scientific advisor to Soft Robotics. As of today the group's most well-known creation is a "squishy, X-shaped quadruped made from elastomers [stretchy plastics]" and controlled by compressed air.
“Hard robots require a sophisticated feedback mechanism to help them determine how much force to apply during surgery so they do not damage our delicate tissues and organs. Soft robots could take advantage of their rubbery appendages to reduce the likelihood of surgical damage,” said CEO of Soft Robotics, Carl Vause.
“Specifically, with medical devices, you would be allowing a robotic instrument to get into a small space, be reconfigurable in that space and do it in a way that’s tissue compliant,” he added.
One other advantage of rubber robots is that they can be printed in 3-D in a single day from silicone and other materials at a much lower cost ($20) than regular robots.
Experiences so far with the best-known robot surgical system, Intuitive Surgical’s da Vinci, have demonstrated the promise and downfalls of traditional medical robots. Da Vinci, which costs about $2 million and was granted approval by the U.S. Food and Drug Administration in 2000, enables surgeons to manipulate laparoscopic instruments and an endoscopic camera attached to four robotic arms. Intuitive Surgical claims more than 1.5 million da Vinci surgeries have been performed in major clinical centers worldwide. Around 367,000 of those procedures were performed last year in the U.S., where about 2,000 systems have been installed. Most procedures were gynecologic or urologic, in particular hysterectomies and prostatectomies.
However, reports point that by utilizing a da Vinci can significantly bump up the cost of surgery by up to $2,500. Additionally, Intuitive Surgical is facing several lawsuits on a range of issues, including sepsis, severe bowel injuries and punctured blood vessels, organs or arteries.
“It will be some time before soft robots are capable of anything nearly as sophisticated as da Vinci, but there is a lot of interest in how this emerging technology could be used in the medical field, either on its own or combined with a surgical system like da Vinci. Soft Robotics is part of a one-year project that the Defense Advanced Research Projects Agency (DARPA) kicked off in June to study how soft robots might be used as battlefield medical tools. By next June,DARPA wants to see if soft robotics can address a number of problems that battlefield medics face,” said Vause.
DARPA is interested in soft robots for a number of reasons; scouting devices or prosthetics for example, to be part of the agency’s Maximum Mobility and Manipulation (M3) program that was initiated back in 2011. Indeed, the Whitesides Research Group, whose work was part of M3, last year developed a $100 silicon robot that could walk, change color, and illuminate in the
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FDA to Regulate Only a Handful of Mobile Medical Apps…
Not every smartphone or tablet app related to health, like an app reminding patients about an appointment, are regulated medical devices. Additionally, not all mobile apps that meet the criteria as medical devices are awarded regulation to begin with, noted the US Food and Drug Administration (FDA) as it issued final guidelines for this technology that are aimed not to squander a revolution in medicine.
The FDA said it would confine its regulatory supervision to what it calls "mobile medical apps,” true medical devices that present "a greater risk to patients if they do not work as intended."
The medical mobile apps that are subject to heavy examination by the FDA can fall into one of three categories. Those that are placed in the first category alter a mobile platform such as a smartphone into a device already in need of FDA approval. A prime example of this is an app that turns an iPhone into an electrocardiography (ECG) machine.
Mobile medical apps found in the second category are supposed to be utilized as an accessory to a regulated device, for instance a tablet that showcases an x-ray from a FDA-approved picture archiving and communication system (PACS) used by radiologists.
While the third and final category includes mobile medical apps that carry out patient-specific analysis and then offer a prognosis, or treatment recommendations, such as a dosage plan for radiation therapy.
“Other than that, most mobile apps in healthcare will not require FDA approval, and some that previously did will no longer need it. Although many mobile apps pertain to health, we are only continuing our oversight for a very small subset of those mobile apps that are medical devices. We have focused our priorities, and taken a big deregulatory action, the biggest we've taken in over a decade,” said director of the agency's Center for Devices and Radiological Health, Jeffrey Shuren, MD.
Moreover, the FDA does not plan to regulate smartphones and tablets themselves in their respective service as platforms for healthcare apps.
“Developers of mobile apps have been asking for guidance about which apps are subject to FDA oversight, and which are not," said Shuren. "Such clarity is critical for attracting investment and accelerating innovation."
Around 100 medical mobile apps have been granted approval for marketing by the FDA within the last decade, 40 of those coming within the past two years.
The FDA guidance board states that many mobile apps for healthcare remain outside FDA jurisdiction because they do not meet the agency's criteria of a medical device, which is any “apparatus or machine used to diagnose, prevent, cure, treat, or mitigate illness, or affect the structure or function of the human body primarily apart from chemical action and metabolism.” Some examples of such apps include:
• Medical reference materials
• Medical education tools such as interactive anatomy diagrams
• General patient education
• Those that automate office operations such as selecting a diagnostic or billing code
A whole other group of mobile apps may technically be eligible as medical devices, but because they pose such a low risk to patients, the FDA will not require manufacturers to seek agency approval under a policy known as "enforcement discretion." Apps in this category:
• Help patients manage chronic conditions such as diabetes without providing specific treatment suggestions
• Help patients organize and track their health information
• Calculate body mass index, mean arterial pressure, APGAR scores, and other clinical measures
• Allow both patients and providers to interact with an electronic health records (EHR) system
More detail on which mobile medical apps that will or will not be regulated can be found on the FDA’s
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Providers Value Functionality in Advanced Viz Software…
Based on a report titled “Advanced Visualization 2013: How Advanced Is It?” conducted by the market research firm KLAS, it was revealed that two-thirds of surveyed providers would consider using their advanced visualization system as their main reading environment as a means of uniting vendors.
Based on the report’s executive summary, this urge to unify would appear to benefit advanced visualization system vendors like Siemens, GE and Philips who are also modality suppliers. Providers who did not wish to use the software as a reading environment pointed out that advanced visualization systems don’t offer the same functionality as the PACS workflow they currently use.
The report also revealed that cardiac, vascular, and neurology are the most important fields for the application of advanced visualization software in the views of most of the providers.
Analyzing the various vendors, Vital ranked as one of the top two vendors in all three of the most vital fields, whereas other vendors had more erratic results. For instance Philips ranked No. 1 in neurology and rated highly in cardiac imaging, but came in fifth for vascular imaging. TeraRecon was one of the leaders in the vascular field, but dragged behind in cardiac and neurology.
“Providers also indicated that high functionality and a positive purchasing experience don’t necessarily go hand-in-hand. Despite scoring top marks for functionality in all but one area, Vital was fourth out of five for sales experience,” according to KLAS.
GE and Philips were recognized as the top vendors with the most user-friendly advanced visualization
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4 Nifty Ways Hospitals Utilize Social Media…
Social media has become a daily part of millions of people’s lives. Hospitals like the Mayo Clinic recognize the power of social media, as reflected by their active twitter account which is currently ranked as No. 1 with more than half a million followers. Cleveland Clinic is third on YouTube, with nearly 3 million views. And the University of Texas M.D. Anderson Cancer Center, in Houston, Texas, ranks 30th on Flickr, with 115 Flickr photos.
All three of these institutions share a common thread of having a powerful, active, and engaging social media interface platform and were rand 1st, 2nd, and 3rd respectively in a recent Top 50 Most Social Media Friendly Hospitals for 2013 listing developed by a group called MHADegree.org; which was founded back in 2007 and is largely funded by an array of colleges and universities with the intent of providing free information to students and healthcare professionals who wish to pursue a master’s degree in health administration.
And given the obvious fact that we are living in a digital age, a job in administration in just about any division will consistently involve releasing some sort of information out to the general public, which translates into the dissemination of such information through the use of social media.
According to editor of MHADegree.org and the social media list’s author, Bethanny Parker, there is no lack of reasons on why healthcare organizations should have a concrete, ever-evolving social media plan in place. Parker also notes four smart ways on how hospitals can utilize social media.
1- Awareness: According to Parker, one of the most vital uses of social media is as a multi-dimensional means of providing new, often times crucial information out to the public. “Perhaps a new test has been developed that can catch a certain cancer earlier. The viral nature, so to speak, of social media can be a very effective means of disseminating information quickly, particularly when that information comes from a highly regarded medical source and can be of immediate use to a patient,” she said.
2- Engaging and connecting with customers: It is no secret that any business needs to uphold its reputation, which makes hospitals and other healthcare providers no different. According to a recent study published by the Journal of Medical Internet Research discovered that “approximately 60 percent of Internet users report using the Internet to look for health information.” Couple those two facts together and it is obvious that hospitals that wish to assist and serve the public must accommodate and engage the public based on where they are, which nowadays is on the Internet.
3- Neutral information: Parker believes one of the more subtle uses of social media is “the way it can provide a way to connect with a healthcare provider without committing to an appointment.” As it is commonly known a patient might be a little hesitant or anxious (based on the severity of the condition) to directly reach out and talk to a healthcare professional about receiving treatment. For instance, through Facebook, providers can supply information and recommendation in open setting, with the objective of making potential patients feel more at ease when it comes to reaching out directly.
4- Flash mobs: While this tactic is a little more unconventional than some of the other options available on social media it can have an impact if employed appropriately; as Parker alluded to a group called Tobacco Control Nigeria that recently utilized a flash mob to educate passer-bys on the hazards of smoking.
Parker has seen the rise of social media prevalence within most major healthcare orginizations and expects it to continue. Programs like Flickr, Instgram, among others are gaining popularity and usage. Terms such as ‘Like,’ and ‘Tweet,’ have become widely understood and used as part of everyday vocabulary. Therefore, it is safe to assume hospitals and social media will continue to evolve
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Class-action Suit Filed against Advocate Medical Group …
A class-action law suit has been filed against Advocate Medical Group in Downers Grove, Ill, by patients who suffered from a massive breach in the group’s computer system. The lawsuit stipulates that the Chicago area's largest physician group violated privacy regulations by failing to use encryption and other security practices to protect patient files.
The law suit comes on top of an investigation led by federal and state authorities on the group after precious information on the medical records/files of millions of patients were unlawfully obtained when four computers from the group’s Park Ridge offices.
Personal information such as names, addresses, dates of birth and Social Security numbers of more than 4 million patients was compromised in the July theft of four computers; making it the second-largest loss of unsecured health information reported to the Department of Health and Human Services since the agency made notification obligatory in 2009.
Albeit the computers themselves were password protected, the actual patient information and records were not encrypted. While detailed medical records were not on the computers, medical data for some patients are also at risk, such as diagnoses, medical record numbers, medical service codes, and health insurance informatio.
"Nothing leads us to believe the computers were taken for the information they contain, and there is no information to suggest any of that data has been used in an inappropriate way,” said senior vice president and chief marketing officer for the nonprofit group, Kelly Jo Golson.
Based on a Ponemon Institute report, states that while most healthcare facilities understand the hazards associated with potential system breaches including violating the Health Insurance Portability and Accountability Act, still many fail to initiate the appropriate plans to effectively prevent one.
“Many times organizations don't fully grasp the need to do so until a breach occurs. And in the Ponemon survey, even among organizations that had been breached, 39 percent still had not put a data risk plan in place. It put healthcare organizations' cost of responding to breaches at $6.78 billion annually,” read the report.
In a statement, Advocate Medical Group highly contested the filing of the lawsuit, but said “we deeply regret any inconvenience” the breach had caused.
“We want to reassure our patients that we do not believe the data was targeted and we have no information that leads us to believe that the information has been misused. Thus, we feel confident the facts will demonstrate that the lawsuit is without merit,” the statement
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No Substantial Improvement made to Health Information …
The Robert Wood Johnson Foundation first published their inaugural report on Health Information Technology in the U.S. in 2006; since then a lot has changed. One example is The Office of the National Coordinator for Health Information Technology having a tight budget, while few hospital beds had operating electronic health records.
Since that time, federal support has vaulted major progress in electronic health record adoption by providers, as noted in the 2013 Robert Wood Johnson Foundation annual report. Yet a further inspection of the report reveals that while providers have made considerable progress and strides in health information technology, they still have quite a ways to go.
Based on the graphs that accompanied the report, it was inferred that current trends in Electronic Health Record (EHR) adoption was how many providers are employing basic systems rather than comprehensive systems; as well as how many companies are utilizing high-level software sanctioned by the government.
Most, 44 percent, had at least a basic EHR in 2012; 27.3 percent had a step-up basic EHR in 2012, and only 16.7 percent had a comprehensive EHR.
According to Forbes, analyst at the International Strategy & Investment Group, Michael Cherny sent out a public letter, notifying clients on the report.
"This study shows some of the challenges with evaluating true market adoption, as it significantly lags the level of adoption seen in the CMS data on stimulus spending (where more than 80 percent of eligible hospitals have received payments for being meaningful users of EHRs)," he wrote.
"But the underlying data from this study shows the continued need to invest further in technology in order to effectively use the data contained in EHRs to drive improved health outcomes and more efficient delivery of care."
The report also covers and offers significant inside information on health information exchanges (HIE), discovering that financial stability is still the greatest challenge confronted by state and regional HIEs. Providers have not been willing to cover the costs for HIE to a certain degree and insurers have been able to support such efforts on a consistent basis, the report notes.
"The hope is that forces beyond HITECH will help promote HIE and create a stronger business case. In particular, new approaches to the delivery and payment of care, such as Accountable Care Organizations, could increase demand for HIE and related services," the report authors wrote.
In closing, the report proposed three tips for making HIE more appealing and stable:
1- Ensure that Stage 3 of meaningful use substantially increases requirements for HIE to increase provider demand for such capabilities
2- Better engage payers in HIE by determining what is holding them back and designing appropriate policies
3- Emphasize to states the need to identify sustainable business models. "While every state has a plan, the viability of these plans has not been rigorously
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ONC Introduces New Plan to Make Reporting IT Hazards …
The Office of the National Coordinator for Health Information Technology (ONC) officials recently revealed the blue-prints to a new plan, designed to reinforce patient safety initiatives and procedures nationwide. The plan comes as a response to the troublesome number of medical errors that are reported each year.
Officials say the Health IT Patient Safety Action & Surveillance Plan is a product that was predicated on recommendations from 2011 Institute of Medicine report on Health IT and Patient Safety. ONC has developed the Health IT Patient Safety Program, within the Office of the Chief Medical Officer, to direct this endeavor.
“When implemented and used properly, health IT is an important tool in finding and avoiding medical errors and protecting patients. This plan will help us make sure that these new technologies are used to make health care safer.” said National Coordinator for Health IT Farzad Mostashari, MD, in a press statement.
The plan highlights the responsibilities to be shared across The Department of Health and Human Services (HHC) and outlines considerable activity and involvement from the private sector.
At first glance, some details of the plan include:
• ONC will make it easier for clinicians to report health IT-related incidents and hazards through the use of certifiedelectronic health record technology.
• The Agency for Healthcare Research and Quality will encourage reporting to patient safety organizations and will update its standardized reporting forms to enable ambulatory reporting of health IT events.
• The Centers for Medicare & Medicaid Services will encourage the use of the standardized reporting forms in hospital incident reporting systems, and train surveyors to identify safe and unsafe practices associated with health IT.
• Working through a public-private process, ONC will develop priorities for improving the safety of health IT. ONC and CMS will consider adopting safety-related objectives, measures, and capabilities for EHRs through the Medicare and Medicaid EHR Incentive Programs and ONC’s standards and certification criteria.
In order to supplement the plan’s surveillance of safety-related abilities in, ONC also provided leadership Tuesday illuminating that ONC-Authorized Certification Bodies will most likely be able to authenticate whether safety-related capabilities work appropriately in live clinical settings in which they are put into practice.
Additionally, Mostashari also declared ONC has gotten in touch with The Joint Commission in an effort to better identify and actively address potential health IT-related safety issues across a multiplicity of healthcare milieus. The Joint Commission plans to enhance its ability to inspect the role of health IT as a causative factor of undesirable events and will classify high priority areas for anticipated types of health IT-related events.
The Office of the National Coordinator for Health Information Technology (ONC) is a staff division within the U.S. Department of Health and Human Services, primarily focused on implementing an interoperable, private and secure nationwide health information system and supporting the widespread, meaningful use of technology. ONC was created in 2004 through an executive order by President George W. Bush, and was legislatively mandated in the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of
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Based on a study published in the Journal of the American College of Radiology, as the iPad is being utilized for as an indicative procedure direction, injection-based procedure planning, and mobile analysis and reading of some imaging studies, the overall majority of radiology residents are using the tablet first and foremost as an educational tool.
"Some sectors of the medical community consider the iPad to be a revolutionary tool in health care delivery, with many use scenarios focused on medical imaging. The purpose of our study was to assess residents' use patterns and opinions of the iPad as a tool for radiology education and clinical practice at an academic medical center," said the study’s co-author, Justin W. Kung, M.D.
A grand total of 38 radiologists residents in the radiology department at Beth Israel Deaconess Medical Center in Boston were given iPad 2 tablets and subscriptions to e-Anatomy and STATdx. Over a six month time frame of employing the device, residents were requested to hand in their judgment and evaluation of the tablet technology to better understand its practical use in medicine and clinical practice.
Of the 38, 36 radiology residents expressed their opinions regarding the tablet. Eighty-six percent reported daily iPad use. Radiology related applications, specifically e-Anatomy, were utilized quite frequently, usually on a weekly or daily basis by 88 percent of respondents.
Furthermore, many resident radiologists preferred to read journal articles on the iPad, however the number of respondents preferring to read textbooks on the iPad as opposed to the traditional bound form was split down the middle.
Radiology residents were also split on the clinical employment of the iPad. A good amount decided not to use the iPad when it came to viewing radiologic images in the diagnostic stage. In addition a little less than half utilized their iPads during readout. And only 12 referred to using the iPad when called to sign prescribed reports and analyses.
"The impact of the iPad on the daily clinical duties of radiology residents in our study was limited, but residents at our institution have adopted the iPad to view electronic journals and use radiology-specific applications. The full impact of this device on resident education will depend on the development of applications that harness the unique ability of this medium for training the next generation of radiologists," said
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Health Apps Ability to Alter Patient Behavior…
There are various health, fitness, and medical apps (applications) that may very well exceed the 40,000 mark. There exists a variety from references to calculators to journals to tracker apps, seen in apps like diabetes managers and heart rate monitors. And although such apps are viewed as ‘cool’ and ‘convenient’ much can be accomplished by smartphone applications as they work to prompt and encourage health lifestyles among users.
Likewise, medical researchers and practitioners have adopted a similar stance on smartphone app technology.
Yet, an ongoing study of 222 smartphone apps that provide tips, advice, and treatment for pain discovered that a lot of these apps were significantly lacking in a scientifically rooted base; and that most presented no proof of healthcare professional involvement.
In addition, healthapp users are aware of the intrinsic problems found in most health-related apps, as one reports reveals 26 percent of users who download health apps use them only once.
“The real key to changing behavior, not just in healthcare but in any consumer experience, is to help people do what they already want to do. That's motivation. There's no way you can browbeat someone to do something they don't want to do. You can just take that one off the table. To help them to do what they want to do, you have to make it really easy to do that thing. That's ability. And then you need a trigger, a reminder, to prompt behavior,” said psychologist BJ Fogg, PhD.
Fogg states that making adjustments to an app’s content won’t make it any more effective than it already may be. In order for apps to truly be effective, Fogg suggests building an app from the ground-up that focuses on “persuasive technology,” a phrase coined by Fogg that integrates mobile technology and the psychological theories and techniques of behavior modification.
“Mobile technology is getting better at understanding where we are, how busy we are, and what our current goal is. In the future, it will get a lot better at prompting us to do the behaviors needed to follow a diet or a medication regimen at a context-sensitive time, not in the middle of us giving a talk at a business meeting. But until then, a lot of behavioral interventions won't work because app designers are thinking not of people's everyday lives, but rather, ‘We're sitting here in an office, and we're engineers. And what we're designing is really great. How can people not do this?" he said.
Fogg doesn’t discredit the possibility of apps helping people adopt healthier lifestyles, however Fogg sees the people behind this technology, software engineers and cognitive scientists, whose paths don’t usually intersect, must seek each other out and work together if any long-term success will be achieved.
“You need a scientist, perhaps a physician, to tell you, ‘What are the behaviors we want the patient with diabetes to do?’ not look at the content. As for the technology, I think the technology will naturally follow. You also need someone who has expertise in evaluating outcomes to run a study and evaluate whether X, Y, or Z behavior that experts feel a patient with diabetes needs to do was actually achieved with the use of the app. I think it has to happen. Otherwise, it's like every pharmacist just making up medications and saying, ‘Here they are.’ There will ultimately probably be many competing ways to evaluate apps and give prescribers confidence regarding which apps will really help them and which apps
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BigBrain: Scientists Construct 3D Road-Map of the …
A groundbreaking development has ushered in a three-dimensional (3-D) digital reproduction of a fully-realized human brain.
Naming it the BigBrain, it now allows the anatomy of the brain to be seen to the tiniest detail(s) using a resolution of 20 mircrons which equate to the size of one strand of hair, for the very first time. The new tool is available within the scientific community as it aims to further advance the field of neuroscience.
Researchers from Germany and Canada worked together to produce an impressively stunning high-resolution brain mockup, featured in the issue of the journal Science.
"The authors pushed the limits of current technology. Such spatial resolution exceeds that of presently available reference brains by a factor of 50 in each of the three spatial dimensions,” said Science's senior editor Peter Stern.
The refined modern image processing methods demonstrates an unparalleled look at the very fine details of the human brain's microstructure, or cellular level. The anatomical tool will allow for three-dimensional cytoarchitectonic mapping and navigation of the human brain and serve as a diagram for small cellular circuit data, or single layers or sublayers of the cerebral cortex, noted the researchers.
Until now, reference brain models could not delve deeper than the macroscopic, or visible, components of the brain. But with the BigBrain, provides a richer resolution than a standard 1 mm resolution from MRI images.
“The project has been a tour-de-force to assemble images of over 7,400 individual histological sections, each with its own distortions, rips and tears, into a coherent 3-D volume. This dataset allows for the first time a 3-D exploration of human cytoarchitectural anatomy,” said professor at the Montreal Neurological Institute at McGill University in Montreal, Canada and senior author Dr. Alan Evans.
The researchers used a 65-year old woman’s brain to cut and map out the anatomical region of the brain from 7,400 pieces. All 7,400 pieces were placed on slides, stained to identify cell structures, and then digitized with a high-resolution flatbed scanner so researchers could replicate the 3-D model. It took around 1,000 hours of collecting data.
“The new reference brain, which is part of the European Human Brain Project, serves as a powerful tool to facilitate neuroscience research and redefines traditional maps from the beginning of the 20th century," stated Director of the Cecile and Oskar Vogt Institute for Brain Research at the Heinrich Heine University Düsseldorf in Germany and lead author, Dr. Katrin Amunts.
Researchers expect the model to be in high demand as it can be used to develop new and valuable tools for visualization, data management, and analysis.
"We plan to repeat this process in a sample of brains so that we can quantify cytoarchitectural variability," said Evans.
"We will also integrate this dataset with high-resolution maps of white matter connectivity in post-mortem brains. This will allow us to explore the relationship between cortical microanatomy and fiber connectivity," added Amunts.
The researchers believe the model will provide deeper insights into the neurobiological basis of cognition, language, emotions and other brain-related
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FDA Calls for Heightened Health IT Cybersecurity …
The U.S. Food and Drug Administration (FDA) is calling for heightened security measures for medical records, applications, and network operations via online.
The FDA is recommending that medical device manufacturers and healthcare facilities to take the steps to guarantee a safeguard to obstruct any cyberattack which could be carried out through the appearance of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks.
The call for optimum security comes at a time when a vast majority of medical devices retain configurable fixed computer systems that can be susceptible to hackers and cyberattacks. In addition, as medical devices are gradually more associated with the Internet, hospital networks, other medical device, and smartphones, there is an amplified hazard of cybersecurity violations, which could negatively affect how a medical device functions.
For all device manufacturers, the FDA is calling on them to remain attentive toward recognizing risks and vulnerability linked to their medical devices, this of course includes risks relevant to cybersecurity, and are in charge of implementing the necessary precautions that address patient safety and guarantee consistent device performance.
The FDA expects medical device manufactures to take the necessary provisions to ensure any unauthorized access to medical devices is warded off and contained. The FDA particularly points out that manufacturers should re-evaluate their cybersecurity strategies and policies to ensure proper protection is present to avert any unauthorized access or alteration to their medical devices or compromise of the security of the hospital network that may be linked to the device itself.
In its guiding principles, the FDA suggests that all medical device manufactures should work to:
- Limit unauthorized device access to only trusted users
- Protect individual components from exploitation
- Craft strategies for active security protections appropriate for a device's use environment
- Provide methods for retention and recovery following security breakdowns
As for healthcare facilities, the FDA regards network security in accordance with protecting the hospital system to be at the forefront of concerns. Therefore, in re-evaluating network security, healthcare facilities should consider the following:
- Restricting unauthorized access to networks and medical devices, and tracking network activity, just in case
- Updating antivirus and firewall efforts, as well as security patches
- Creating and evaluating strategies for maintaining functionality during adverse events
"We are aware of hundreds of medical devices that have been infected by malware. It's not difficult to imagine how these types of events could lead to patient harm,” said deputy director for science at FDA's Center for Device and Radiological Health, Bill Maisel.
For now the FDA is taking security measures one step at a time, encouraging medical device manufactures and healthcare facilities to thoroughly examine the guidelines made available to them; and cooperate with the FDA in a concerted effort to significantly limit any possibilities of a
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MDCT: Informatics can be used to Assess CT Image …
At the International Symposium on Multidetector-Row CT in Washington, DC, it was acknowledged that the field of Radiology has progressed a great deal over the years. Through the continuation of advancing CT image quality and managing radiation dosage, radiology, along with the assistance of imaging informatics can establish this specific science into medical practice.
Radiology institutions may use informatics to scale a practice’s CT images alongside national data, thus issuing a viable means of reviewing not only equipment, but staff productivity as well. The University of Maryland provides an example of this:
"We've created an informatics platform to collect data from radiologists and technologists that includes a feedback category on image quality. The feedback we get from the data allows us to fine-tune our performance. The entire department benefits from it, as it provides management support and quality control,” said Dr. Eliot Siegel.
Siegel also notes the differences in CT image quality across the U.S. as radiologists have their own opinions of what makes a quality image. Even the RSNA’s booklet on radiology terminology, RadLex, doesn’t necessarily offer an answer to the problem. It uses all kinds of terms to rate image quality such as "nondiagnostic," "limited" (unable to offer any insight), "diagnostic" (ordinary quality, usable), and "exemplary" (should be the standard).
“Payors don't take CT image quality into consideration except at a basic ‘yes’ or ‘no’ accreditation level, and the current accreditation process is limited in its ability to assess and document image quality. Right now, it's 'pick your best exams every three years, and we'll pass or fail you,” said Siegel.
Tracing CT image quality is crucial because not only does it maximize patient care and precision in diagnosis, but also helps calculate the transaction between radiation exposure, dose, and quality.
"If we don't have a mechanism to determine image quality and we don't have a way to determine how to improve it, then it's going to be difficult to optimize dose,” mentioned Siegel.
Tracing CT image quality is also useful in the respect that it allows users to evaluate the equipment itself.
"Image quality data can help determine when it's time to get a new CT scanner. And if a practice has multiple scanners, it can help determine when to put patients on the better scanner and when to use the less optimal scanner,” added Siegel.
Siegel also cites most radiologists don’t frequently assess CT image quality and urges a routine methodology to be set in place.
This is the premise behind informatics tools as they utilize the tracing of several quality images on a consistent basis, paint an entire picture on the productivity levels of the department, and offer pertinent feedback, creating a type of quality report card.
Siegel suggests that every image should be assessed by the technologist, the radiologist, and an automated assessment through a computer-based diagnosis, thus allowing technicians to compare and improve their work and review and rate images on the scanner.
Regardless, radiologists must evaluate CT image quality regularly.
"Quality assessment shouldn't just be part of a three-year accreditation cycle. It should be a continuous process,” finished
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