FDA Clears First Diagnostic Radiology Application for Mobile Devices

/PRNewswire/ -- A new mobile radiology application cleared today by the U.S. Food and Drug Administration will allow physicians to view medical images on the iPhone and iPad manufactured by Apple Inc.

The application is the first cleared by the FDA for viewing images and making medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET). It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.

"This important mobile technology provides physicians with the ability to immediately view images and make diagnoses without having to be back at the workstation or wait for film," said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health.

Radiology images taken in the hospital or physician's office are compressed for secure network transfer then sent to the appropriate portable wireless device via software called Mobile MIM. Mobile MIM, manufactured by Cleveland-based MIM Software Inc., allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest.

In its evaluation, the FDA reviewed performance test results on various portable devices. These tests measured luminance, image quality (resolution), and noise in accordance with international standards and guidelines. The FDA also reviewed results from demonstration studies with qualified radiologists under different lighting conditions. All participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions.

The display performance of mobile devices can experience significant variations in luminance levels even between mobile devices of the same model. The Mobile MIM application includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions. The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen. If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician's ability to discern subtle differences in contrast. In addition, a safety guide is included within the application.

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UGA researchers develop rapid diagnostic test for common type of pneumonia

University of Georgia researchers have developed a technique that can diagnose a common type of pneumonia within minutes, potentially replacing existing tests that can take several days for results.
The researchers, whose findings are detailed online in the journal PLoS ONE, detected Mycoplasma pneumoniae, which causes atypical or “walking pneumonia,” in true clinical samples with over 97 percent accuracy using a recently-developed nanotechnology-based platform.

“If you can make a positive identification from a 10-minute test, then appropriate antibiotics can be prescribed, limiting both the consequences in that patient and the likelihood that it will spread to others,” said lead-author Duncan Krause, a professor in the department of microbiology in the UGA Franklin College of Arts and Sciences.

Krause and his colleagues built upon an existing technology called surface-enhanced Raman spectroscopy, which works by detecting spectral signatures of a near-infrared laser as it scatters off a biological specimen. They were able to enhance the Raman signal by using silver nanorod arrays to detect the tiny bacteria in throat swab specimens.

Krause, who also directs the interdisciplinary UGA Faculty of Infectious Diseases, compared the nanorod array developed by collaborator Yiping Zhao, director of the UGA Nanoscale Science and Engineering Center, to a brush with densely packed bristles, where each of the tiny silver rods extends out at a specific angle. The sample, such as bacteria from a throat swab, penetrates among the bristles, where the spectral signature produced by the laser is amplified and then analyzed by a computer program.

Krause noted that infections due to M. pneumoniae are very common yet difficult to diagnose. The bacterium is a major cause of respiratory disease in humans and the leading cause of pneumonia in older children and young adults.

“Walking pneumonia feels like a bad chest cold that will not go away,” he explained. “It can persist for weeks and even months and can cause permanent damage to the lungs if not diagnosed promptly. A delay in diagnosis extends the likelihood for complications as well as continued transmission of the infection to others.”

Krause said the device can be reduced to a size that could fit in a briefcase, although their testing is currently done only in a laboratory setting. “Our hope is that when we begin to explore the capabilities of this technology, it can be applied in point-of-care testing,” he added. “Then the impact becomes truly significant.”

Krause hopes the combined efforts of the research specialists in nanotechnology and infectious disease will eventually be able to determine if the technique is effective in detecting other pathogens in clinical samples. “We need to do a thorough job with mycoplasmas first,” said Krause. “Then we can go to other clinical samples and ask the same questions with other infectious agents.”

Funding for the research was provided by the U.S. Army Research Laboratory, the National Science Foundation and the Georgia Research Alliance.

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NIH Awards $10 Million to Develop Microneedle Vaccine Patch

The National Institutes of Health (NIH) has awarded $10 million to the Georgia Institute of Technology, Emory University and PATH, a Seattle-based nonprofit organization, to advance a technology for the painless, self-administration of flu vaccine using patches containing tiny microneedles that dissolve into the skin.

The five-year grant will be used to address key technical issues and advance the microneedle patch through a Phase I clinical trial. The grant will also be used to compare the effectiveness of traditional intramuscular injection of flu vaccine against administration of vaccine into the skin using microneedle patches. In animals, vaccination with dissolving microneedles has been shown to provide immunization better than vaccination with hypodermic needles.

"We believe that this technology will increase the number of people being vaccinated, especially among the most susceptible populations of children and the elderly," said Mark Prausnitz, a professor in the Georgia Tech School of Chemical and Biomolecular Engineering, and the project's principal investigator. "If we can make it easier for people to be vaccinated and improve the effectiveness of the vaccine, we could significantly reduce the number of deaths caused every year by influenza."

Vaccine-delivery patches contain hundreds of micron-scale needles so small that they penetrate only the outer layers of skin. Their small size would allow vaccines to be administered without pain -- and could allow people to apply the patches themselves without visiting medical facilities.

While the ability to immunize large numbers of people without using trained medical personnel is a key advantage for the microneedle patch, the researchers have learned that administering the vaccine through the skin creates a different kind of immune response -- one that may protect vaccine recipients better.

"We have seen evidence that the vaccine works even better when administered to the skin because of the plethora of antigen presenting cells which reside there," said Ioanna Skountzou, co-principal investigator for the project and an assistant professor in Emory University's Department of Microbiology and Immunology. "This study will allow us to determine how we can optimize the vaccine to take advantage of those cells that are important in generating the body's immune response."

Among the issues to be addressed in the five-year study are:

• Developing an administration system that will be simple to use, intuitive and reliable. "Our goal is to make these patches suitable for self-administration, so that anybody could take a patch out of an envelope, put it on, and have it work with high reliability," Prausnitz said.

• Studying the long-term stability of vaccine used in the patches, and optimizing technology for incorporating it into the dissolving microneedles. "We need to put the vaccine into a dry form in this patch," said Prausnitz. "That will require different processing than is normally done with vaccines. We expect that this dry vaccine will provide enough stability that the patches can be stored without refrigeration."

• Evaluating the economic, regulatory, social and medical implications of a self-administered vaccine. PATH, an international nonprofit organization, will assist with this work, and will help strategically address any issues. "We will be assessing the barriers that may exist to introduction of a self-administered flu vaccine so we can anticipate those issues and develop possible solutions," said Darin Zehrung, leader of the vaccine delivery technologies group at PATH.

The funding will come from the Quantum program of the National Institute of Biomedical Imaging and Bioengineering (NBIB), which is part of the NIH. The initiative is designed to bring new medical technologies into clinical use.

While the funding focuses specifically on influenza vaccination, the lessons learned may advance other microneedle applications -- including vaccination efforts in developing countries where skilled medical personnel are limited and concerns about re-use of hypodermic needles are significant.

Additional design and development of the microneedle patch will largely be done at Georgia Tech, with vaccine development, immunological studies and the Phase I trial carried out at Emory University. The trial, to be conducted by the Hope Clinic of the Emory Vaccine Center, is expected to take place during the final year of the grant, setting the stage for Phase II and Phase III clinical trials that would be required to obtain FDA approval.

Ultimately, the goal will be to produce an influenza vaccine delivery patch that could be made widely available. Prausnitz expects that will be done by an established company with the ability to manufacture and market the devices.

Microneedle drug and vaccine delivery systems have been under development at Georgia Tech and elsewhere since the 1990s. The technology got a significant boost in July of 2010 with publication of a study in Nature Medicine that showed mice vaccinated with dissolving microneedles were protected against influenza at least as well as mice immunized through traditional hypodermic needle injections.

The patches used in that study contained needles just 650 microns long, assembled into arrays of 100 needles. Pressed into the skin, the needles quickly dissolved into bodily fluids thanks to their hydrophilic polymer material, carrying the vaccine with them and leaving only a water-soluble backing. In contrast, use of hypodermic needles leaves the problem of "sharps" disposal.

Prausnitz hopes that the $10 million in NIH funding will help accelerate development of the microneedle patches to make them available for general use within five to ten years.

"This research will focus on optimizing the microneedle-based delivery of vaccines into the skin and understanding how this method affects immune responses both at the mucosal surfaces of the body and through the systemic response inside the body," added Skountzou. "Combined with the convenience of self-administration, painless application and absence of sharps waste, this novel immunization route could make the microneedle patch a powerful new weapon against infectious diseases."

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ONC Issues Final Rule to Establish the Temporary Certification Program for Electronic Health Record Technology

The Office of the National Coordinator for Health Information Technology (ONC) on June 18 issued a final rule to establish a temporary certification program for electronic health record (EHR) technology. The temporary certification program establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify EHR technology.

Use of “certified EHR technology” is a core requirement for providers who seek to qualify to receive incentive payments under the Medicare and Medicaid Electronic Health Record Incentive Programs provisions authorized in the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH was enacted as part of the American Recovery and Reinvestment Act (ARRA) of 2009. The Centers for Medicare & Medicaid Services will soon issue final regulations to implement the EHR incentive programs.

Certification is used to provide assurance and confidence that a product or service will work as expected and will include the capabilities for which it was purchased. EHR technology certification does just that: It assures health care providers that the EHR technology they adopt has been tested and includes the required capabilities they need in order to use the technology in a meaningful way to improve the quality of care provided to their patients.

On March 10, 2010, the U.S. Department of Health and Human Services (HHS) issued a notice of proposed rulemaking (NPRM) entitled Proposed Establishment of Certification Programs for Health Information Technology. The NPRM proposed the establishment of two certification programs for purposes of testing and certifying EHRs —one temporary and one permanent. The temporary certification program final rule issued today will become effective upon publication in the Federal Register. The final rule for the permanent certification program is expected to be published this fall.

“By purchasing certified EHR technology, hospitals and eligible professionals and hospitals will be able to make EHR purchasing decisions knowing that the technology will allow them to become meaningful users of electronic health records, qualify for the payment incentives, and begin to use EHRs in a way that will improve quality and efficiency in our health care system,” said David Blumenthal, M.D., M.P.P., national coordinator for health information technology. “We hope that all HIT stakeholders view this rule as the federal government’s commitment to reduce uncertainty in the health IT marketplace and advance the successful implementation of EHR incentive programs.”

This final rule is issued under the authority provided to the National Coordinator for Health Information Technology in section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the HITECH Act.

For more information about the temporary certification program and rule, please visit http://healthit.hhs.gov/certification.

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CMS and ONC Issue Regulations Proposing a Definition of 'Meaningful Use' and Setting Standards for Electronic Health Record Incentive Program

The Centers for Medicare & Medicare Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) encourage public comment on two regulations issued today that lay a foundation for improving quality, efficiency and safety through meaningful use of certified electronic health record (EHR) technology. The regulations will help implement the EHR incentive programs enacted under the American Recovery and Reinvestment Act of 2009 (Recovery Act).

A proposed rule issued by CMS outlines proposed provisions governing the EHR incentive programs, including defining the central concept of "meaningful use" of EHR technology. An interim final regulation (IFR) issued by ONC sets initial standards, implementation specifications, and certification criteria for EHR technology. Both regulations are open to
public comment.

"Widespread adoption of electronic health records holds great promise for improving health care quality, efficiency, and patient safety," said, National Coordinator for Health Information Technology David Blumenthal, M.D., M.P.P. "The Recovery Act's financial incentives demonstrate Congress' and the Administration's commitment to help providers adopt and make meaningful use of EHR technology so they can give better care and their patients' experience of care will improve. Over time, we believe the EHR incentive program under Medicare and
Medicaid will accelerate and facilitate health information technology adoption by more individual providers and organizations throughout the health care system."

"These regulations are closely linked," said Charlene Frizzera, CMS acting administrator. "CMS's proposed regulation would define and specify how to demonstrate 'meaningful use' of EHR technology, which is a prerequisite for receiving the Medicare incentive payments. Our rule
also outlines the proposed payment methodologies for the Medicare and Medicaid EHR incentive programs. ONC's regulation sets forth the standards and specifications that will enhance the interoperability, functionality, utility and security of health information technology."

CMS and ONC worked closely to develop the two rules and received input from hundreds of technical subject matters experts, health care providers, and other key stakeholders. Numerous public meetings to solicit public comment were held by three Federal advisory committees:
the National Committee on Vital and Health Statistics (NCVHS), the Health IT Policy Committee (HITPC), and the Health IT Standards Committee (HITSC). HITSC presented its final recommendations to the National Coordinator in August 2009. These recommendations, along with all other input were considered to help inform the development of the regulations announced today.

The IFR issued by ONC describes the standards that must be met by certified EHR technology to exchange healthcare information among providers and between providers and patients. This initial set of standards begins to define a common language to ensure accurate and secure health information exchange across different EHR systems. The IFR describes standard formats for clinical summaries and prescriptions; standard terms to describe clinical problems, procedures, laboratory tests, medications and allergies; and standards for the secure transportation of this information using the Internet.

The IFR calls for the industry to standardize the way in which EHR information is exchanged between organizations, and sets forth criteria required for an EHR technology to be certified. These standards will support meaningful use and data exchange among providers who must use
certified EHR technology to qualify for the Medicare and Medicaid incentives.

Under the statute, HHS is required to adopt an initial set of standards for EHR technology by Dec. 31, 2009. The IFR will go into effect 30 days after publication, with an opportunity for public comment and refinement over the next 60 days. A final rule will be issued in 2010.
"We strongly encourage stakeholders to provide comments on these standards and specifications," Dr. Blumenthal said.

The Recovery Act established programs to provide incentive payments to eligible professionals and eligible hospitals participating in Medicare and Medicaid that adopt and make "meaningful use" of certified EHR technology. Incentive payments may begin as soon as October 2010 to
eligible hospitals. Incentive payments to other eligible providers may begin in January 2011.

The proposed rule would define the term "meaningful EHR user" as an eligible professional or eligible hospital that, during the specified reporting period, demonstrates meaningful use of certified EHR technology in a form and manner consistent with certain objectives and
measures presented in the regulation. These objectives and measures would include use of certified EHR technology in a manner that improves quality, safety, and efficiency of health care delivery, reduces health care disparities, engages patients and families, improves care
coordination, improves population and public health, and ensures adequate privacy and security protections for personal health information.

The proposed rule would define meaningful use for the Medicare EHR incentive programs. It proposes one definition that would apply to eligible professionals participating in the Medicare fee-for-service and the Medicare Advantage EHR incentive programs as well as a proposed
definition that would apply to eligible hospitals and critical access hospitals. These definitions also would serve as the minimum standard for eligible professionals and eligible hospitals participating in the Medicaid EHR incentive program. The rule proposes that states could
request CMS approval to implement additional meaningful use measures, as appropriate, but could not request approval of fewer or less rigorous meaningful use measures than required by the rule.

This rule proposes a phased approach to implement the proposed requirements for demonstrating meaningful use. This approach would initially establish reasonable criteria for meaningful use based on currently available technological capabilities and providers' practice
experience. CMS will establish stricter and more extensive criteria for demonstrating meaningful use over time, as anticipated developments in technology and providers' capabilities occur.

CMS provides a 60-day comment period on the proposed rule. "The definition and requirements for demonstrating meaningful use of EHR technology are proposals. CMS welcomes and will give serious consideration to comments that improve our proposal while achieving the
goals Congress established for the EHR incentive programs," Frizzera said.

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Patients Gain Protections in Health Information Technology Law

/PRNewswire-USNewswire/ -- Patients across the United States will benefit from a new health information technology (HIT) law providing comprehensive privacy and security standards for patient records including strong, protective provisions for psychotherapy records. The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the economic stimulus package, was passed by the House and Senate on February 13 and signed into law by President Obama on February 17.

The HITECH Act builds on the federal government's current efforts to encourage the development of a national interoperable, electronic health records network with the goal of providing improved patient care at lower cost. The core of the HITECH Act contains provisions to ensure records privacy and security as HIT develops. The Act will:

-- Provide for an ongoing process for setting standards to better ensure
that privacy and security are protected in the health care system

-- Incorporate Health Insurance Privacy and Accountability Act (HIPAA)
Privacy and Security Rule standards, where possible, including with
regard to psychotherapy notes and other sensitive patient information

-- Improve upon the HIPAA "minimum necessary" standard, which requires
that only the minimum amount of patient information can be disclosed
depending on the request for the information

-- Implement further restrictions on health care plan use of patient
records for administrative "health care operations" purposes

-- Allow a patient to pay privately for health care and not have his or
her records included in an electronic network

-- Implement a process to explore segmenting particularly sensitive
patient records (such as mental health records)

-- Provide a notice to the patient when privacy is breached

-- Examine technologies to help patients track how their records have
been disclosed

-- Contain new strong patient enforcement measures and strengthen
existing HIPAA enforcement measures

-- Require Health and Human Services to study expanding the HIPAA
psychotherapy notes authorization requirement to include mental health
testing data

-- Make psychologists eligible for funding provisions in the law to
implement health information technology into their practices and to
join into electronic networks in their communities

-- Preserve stronger state privacy laws and allow the continued
application of state consent provisions

-- Require a study for providing for patient consent in electronic
records systems

-- Protect the well-established psychotherapist-patient privilege
currently recognized under federal and state law, and

-- Provide for continued Congressional oversight to ensure the bill's
privacy and security standards are effective.

The HITECH Act is the most comprehensive HIT legislation introduced by Congress and represents a giant leap forward for psychologists and their patients, achieving strong patient records privacy and security protections.

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New Wound Care Camera Computes Area of Wound

(BUSINESS WIRE)--Today, IP2Biz announced that a prototype wound measurement camera is being tested by wound specialty nurses at the Shepherd Center in Atlanta, Georgia. The handheld device determines and captures wound boundaries and wound area using proprietary software and low-cost hardware. The device provides fast, accurate and repeatable digital documentation of wound progression, a necessary component to validate payment from insurance and government agencies.

The Shepherd Center is a nationally recognized, not-for-profit hospital that focuses on medical care and rehabilitation for patients requiring highly-specialized care. Nurses using the device say that “the device easily fits in your hands, can be operated with just a click and gives us confidence that the measurements can be repeated consistently. It is a great improvement over our current methods.” The technology development was led by Stephen Sprigle, Associate Professor of Applied Physiology and Industrial Design at the Georgia Institute of Technology.

“We designed the device to address a key and growing need in wound management,” said Sprigle. “Our goal was to provide a low-cost, easy-to-use device that used the latest technology to provide measurements of the area of the wound.” The device does not require patient contact, thus providing maximum infection control. The simple design is intuitive to use and requires minimal training, thus making it ideal for use in a wide range of environments, including homecare.

Dr. John Hitt of IP2Biz sees a growing need for wound management. “Hospitals, rehabilitation clinics and specialized care centers all need to address the increasing requirements for pay-for-performance healthcare,” says Hitt. “This device enables healthcare providers to consistently document healing and meet validation requirements from Medicare/Medicaid and insurance agencies.” The technology is licensed exclusively to IP2Biz from the Georgia Tech Research Corporation.

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Emory Crawford Long Hospital a First to Use High-Tech Robotic Catheter for Treatment of Abnormal Heart Rhythm

A high-tech computer, a joystick, sound effects and three large computer monitors. No, it is not the latest video game. Instead, it's a new robotic catheter system used at Emory Crawford Long Hospital to treat irregular or abnormal heartbeats. The hospital, part of Emory Healthcare, is the first in the Southeast to use the new system.

Called the Sensei, the robotic catheter system is used to treat patients with arrhythmias, a heart condition where electrical impulses of the heart are abnormal. These abnormalities can cause the heart rate to be too slow or too fast, or sometimes, the heart rhythm can be erratic.

"This new robotic system offers more precise movements and stability when guiding a catheter through the heart for radiofrequency ablation," says David DeLurgio, MD, director of the electrophysiology labs at Emory Crawford Long Hospital. "The system is also operated remotely and allows the physician to sit during the procedure, which helps doctors reduce fatigue during long or multiple cases."

Radiofrequency ablation is a nonsurgical procedure used to treat some types of arrhythmias, particularly rapid and uncoordinated heartbeats. It's the preferred treatment for this disorder and has a success rate of over 90 percent, along with low risks of complications.

Using live X-ray, a doctor guides the robotic catheter with an electrode at its tip into the heart. Then the doctor places the tip at the exact site inside the heart where cells are giving off electrical signals that stimulate the abnormal heart rhythm. Mild and painless radiofrequency energy (similar to microwave heat) is transmitted to the target area. This destroys carefully selected heart muscle cells in a very small area (about 1/5 inch). The treatment stops the area from conducting the extra impulses that cause the rapid heartbeats.

"We've been doing manual radiofrequency ablation for various arrhythmias for 15 years at Emory Crawford Long Hospital, because it is tried and true," says DeLurgio, an associate professor of medicine (cardiology), Emory University School of Medicine. "The benefits of now using the robotic catheter are its accuracy and improved control over the tip of the catheter."

Another benefit is reducing the doctor's exposure to radiation from the live X-rays, because the system is remote. Electrophysiologists like DeLurgio can do as many as five cases each day, so exposure reduction is a plus.

"Because Emory Crawford Long Hospital's Heart and Vascular Center is a high-volume heart center, performing nearly 500 ablation cases a year, this new technology will be advantageous to both our patients and doctors," says DeLurgio.

The robotic catheter is made by Hansen Medical and is covered by most insurance companies.
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