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ComplianceHome is one of the Web's largest library of resources for compliance management of HIPAA, SOX, FISMA, GLBA, FDA, COOP & COG, FFIEC, Basel II, OSHA and ISO 27002/17799. Visit our directories which are the best source on White papers, related news articles, resources on the web, training, webinars, conferences, rules & regulation overview, ask the expert, job and search on vendors, solutions & products. Mon, 05 Jan 2009 07:00:00 +0100 The National Safety Council (NSC) is introducing two new versions of the OSHA Walkthrough for Industry training program. Like the original program, these versions are great for educating new employees or refreshing the expertise of seasoned staff. The NSC's original OSHA Walkthrough for Industry covers 22 regulatory topics using content from the U.S Occupational Safety & Health Administration's 10-hour training program. The NSC program features an animated character to present lessons and quizzes in an interactive, entertaining manner that enhances retention.
Mon, 05 Jan 2009 07:00:00 +0100 The Trumbull, CT-based HiFi DNA Tech wants the US Food and Drug Administration (FDA) to reduce unnecessary biopsies on women, by rescinding its approval of expanded use of human papillomavirus (HPV) test results for triage referral to colposcopy. More than 95% of referrals to colposcopic biopsy for diagnostic workup in the U.S. are performed needlessly on healthy women or women who have mostly reversible cervical cellular change. Screening with combined cytologic and HPV testing leads to the highest number of excessive colposcopic referrals, quoted Sin Hang Lee, M.D. from a publication by the Department of Health Policy and Management, Harvard School of Public Health in his letter sent to the FDA Commissioner. Dr. Lee requests immediate FDA action to reverse this trend by withdrawing the approval order of March 31, 2003.
Mon, 05 Jan 2009 07:00:00 +0100 Four leading healthcare industry organizations announced they are collaborating with the Centers for Medicare and Medicaid Services (CMS) on the formation of a 5010 Testing Project to address real-time testing of the new X12 HIPAA 5010 transactions implementation. The organizations include CAQH, the Healthcare Information and Management Systems Society (HIMSS), the Integrating the Healthcare Enterprise (IHE) Initiative, and the Blue Cross and Blue Shield Association (BCBSA). The groups will demonstrate ways to implement the 5010 HIPAA transaction standards through existing testing tools, best practices and public-private collaborations that are already broadly recognized within the healthcare industry. Specifically, these include CAQH's Committee on Operating Rules for Information Exchange (CORE) Phase I and II rules certification testing scripts, the IHE interoperability framework, and Interoperability Specifications developed by the Healthcare Information Technology Standards Panel (
Mon, 05 Jan 2009 07:00:00 +0100 The U.S. Food and Drug Administration announced that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M. FDA has cited the defendants on multiple occasions, most recently following inspections of the dairies from June 24 to July 1, 2008. During these inspections the FDA investigator noted that the defendants were not keeping adequate medication records to prevent unsafe drug residues in cattle offered for slaughter, that they failed to review treatment records prior to offering an animal for slaughter, and that they were using medications for unapproved indications not specified on the drug label.
Sun, 04 Jan 2009 07:00:00 +0100 The U.S. Food and Drug Administration today approved the cobas TaqScreen MPX Test, the first nucleic acid test that screens for the presence of two divergent types of HIV in donated blood plasma and tissue. With the MPX test, blood donor testing laboratories will be able to use nucleic acid technology to screen for additional HIV strains, further assuring that donated blood and tissue are free from infection and providing better protection for patients, said Jesse L. Goodman, M.D., M.P.H., director of the FDAs Center for Biologics Evaluation and Research.
Sun, 04 Jan 2009 07:00:00 +0100 The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube. On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS). At that time, AMO informed customers of the number and nature of adverse event reports associated with OVD from that lot, and included a fax reply form for quick communication.
Sun, 04 Jan 2009 07:00:00 +0100 The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M. FDA has cited the defendants on multiple occasions, most recently following inspections of the dairies from June 24 to July 1, 2008. During these inspections the FDA investigator noted that the defendants were not keeping adequate medication records to prevent unsafe drug residues in cattle offered for slaughter, that they failed to review treatment records prior to offering an animal for slaughter, and that they were using medications for unapproved indications not specified on the drug label. Although using drugs in this extralabel manner is legal with a valid veterinarian-client-patient relationship, the defendants did not have such a relationship.
Thu, 01 Jan 2009 07:00:00 +0100 Quality is absolutely our way of life at Budco, emphasized President Terry Niles. By precisely defining quality procedures and ingraining them in the day-to-day execution of client projects, the Quality Operating System enables Budco to perform at the highest levels of accuracy and customer satisfaction. That's why we formalized our quality processes two decades ago as the Quality Operating System; that's also why we continue to so rigorously adhere to QOS and ISO 9001:2000 standards today. Our commitment never waivers, continued Ms. Niles. Other companies may cut back or eliminate quality processes when facing economic challenges. But not Budco. In fact, we find that sticking to our quality principles differentiates us from the competition and contributes to our business success by giving us an advantage that clients appreciate and demand.
Thu, 25 Dec 2008 07:00:00 +0100 The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels. Although MRA can be performed without the use of a contrast imaging agent, Vasovist administration provides a clearer image in patients who are suspected of having blockages or other problems with the blood vessels in their abdomen or limbs. The MRA is performed using magnetic resonance imaging (MRI), which relies on magnetic fields to create highly detailed images of the inside the body.
Thu, 25 Dec 2008 07:00:00 +0100 RedVector has announced the release of two new OSHA courses. With the release and immediate availability of OSHA Safety: Introduction to Powered Industrial Trucks and OSHA Recordkeeping: General Recording Criteria, RedVector once again demonstrates its commitment to providing the highest quality and most accessible continuing education and professional development courses to the design and construction industries.
Wed, 24 Dec 2008 07:00:00 +0100 Informatica Corporation, provider of data integration software and services, today announced the availability of Informatica Data Transformation Accelerator a new tool that enables companies to dramatically reduce the cost of on-boarding and managing electronic business partners. Efficiency in Todays Macro-economic Climate The Data Transformation Accelerator is the latest addition to the Informatica B2B Data Exchange family of products; technologies that enable multi-enterprise data integration. The Data Transformation Accelerator (Accelerator) makes it possible for business analysts to quickly create and validate data mappings using Excel, substantially reducing the back-and-forth communication between analysts and IT developers that is typically required to complete multi-enterprise integration projects.
Tue, 23 Dec 2008 07:00:00 +0100 Cal/OSHA investigators this month issued $25,085 in citations for safety and health violations at two Los Angeles Carwash businesses. The companies, Vermont Carwash and Hollywood Carwash were inspected on July 28, 2008 after the Los Angeles Cal/OSHA office received complaints filed by the Southern California Coalition on Occupational Safety and Health on behalf of the employees working at the businesses. Carwashes and other operations using energized machinery and hazardous chemicals have specific requirements they must meet to control exposure and prevent accidents, said Cal/OSHA Chief Len Welsh. Serious injuries or even fatal accidents can be caused by this kind of work if employers fail to protect employees from the types of hazards we found.
Tue, 23 Dec 2008 07:00:00 +0100 Ensuring worker safety and health during Interstate 80 bridge construction over the Missouri River is the goal of a new strategic partnership formed between the U.S. Department of Labors Occupational Safety and Health Administration (OSHA) and Jensen Construction Co. of Des Moines, Iowa.Along with Jensen, general contractor for the new I-80 bridge, OSHA also has extended program participation to subcontractors working on the bridge project. The bridge links Omaha, Neb, and Council Bluffs, Iowa.
Tue, 23 Dec 2008 07:00:00 +0100 Trinity Biotech plc (NASDAQ: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced the filing of its 510k submission with the FDA for its new high throughput coagulation analyzer, the Destiny Max. Trinity recently obtained CE marking which enables it to sell the Destiny Max in Europe and has now filed its 510k submission with the FDA seeking permission to sell the instrument in the United States. The target market for the instrument in both markets includes university hospitals, high throughput general hospitals, high volume commercial laboratories and reference laboratories.
Tue, 23 Dec 2008 07:00:00 +0100 IGT, a pioneer in travel technologies and services received the coveted PCI DSS 1.2 certification from leading PCI DSS QSAC, ControlCase. IGT is the first Travel BPO Organization to become PCI DSS 1.2 compliant. It has successfully met the newest version of the Payment Card Industry Data Security Standard (PCI DSS) compliance requirements. ControlCase conducted a meticulous audit process of IGTs security measures used in protecting e-commerce customers and their data involving travel transactions.ControlCase awarded IGT with the PCI DSS 1.2 compliance rating after IGT met the 259 Requirements (grouped into 12 broad categories) that make up the control objectives. Data security continues to be a concern for customers making payments over the internet. IGT supports millions of travel transactions annually and enables consumers to make travel purchases in a highly secure manner both online and remotely.
Mon, 22 Dec 2008 07:00:00 +0100 The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers health at risk. An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers' health at risk.
Sun, 21 Dec 2008 07:00:00 +0100 In the final weeks of Republican control of Washington, the Bush Administration's OSHA has entered into a nearly toothless settlement agreement with Cintas over lethal violations in its laundries. The agreement attempts to resolve six OSHA cases relating to citations against Cintas for safety hazards at laundry facilities across the country, including hazards that led to the March 2007 death of Cintas worker Eleazar Torres Gomez. Unsafe conditions at Cintas have garnered nationwide media attention and the largest penalty in the service industry. Unfortunately, the agreement not only downgrades the severity of the 43 willful violations issued against Cintas since last spring, but also allows for a two-year delay in many plants across the country in guarding the kind of machines which caused the death of Eleazar Torres Gomez. Torres Gomez was pulled by a conveyor into a 300-degree industrial dryer and trapped for 20 minutes, dying of trauma and thermal injuries. The settlement agreeme
Fri, 19 Dec 2008 07:00:00 +0100 nCircle, provider of automated security and compliance auditing solutions, today announced 4 new PCI partnerships; Datassurant of Reston, Virginia, Sacramento Technology Group LLC of Folsom, California, American Technology Corporation (ATC) of St Louis, Missouri and RavenEye of Tampa, Florida. All partners will be using the nCircle Certified PCI Scan Service(TM) as a component of the PCI compliance services they deliver to their customers. The nCircle Certified PCI Scan Service -- based on nCircle's market-leading auditing technology used by more than 4000 customers worldwide -- delivers an end-to-end automated PCI compliance certification service to accurately evaluate a merchant's payment network, prioritize and address vulnerabilities based on the PCI Data Security Standard and generate the required report certifying compliance efficiently and cost-effectively.
Thu, 18 Dec 2008 07:00:00 +0100 Apani, the preeminent provider of cross-platform server isolation solutions for large enterprises, today announced a partnership with Splunk, the IT Search Company, to offer its innovative IT Search capability with EpiForce(R), Apani's network security product family. EpiForce will now feature Splunk's IT Search and reporting capabilities to create on-demand customized reports and drill down on critical network activity. As data centers become more complex, it becomes increasingly more difficult to gain access to valuable IT data. Network activity and user analytics remain a mystery while IT resources, that should be deployed to maintain complex networks, are busy analyzing logs to provide some level of visibility to executive management. By adding Splunk's powerful on-demand IT Search technology to generate custom reports, Apani has added a new dimension of functionality to EpiForce's already comprehensive monitoring capabilities.
Thu, 18 Dec 2008 07:00:00 +0100 Agion Technologies has announced it has signed an agreement with Stryker Corporation's Instruments Division to incorporate Agion's natural antimicrobial technology into a new pain management catheter. The product, Silver ExFen Catheter, has achieved FDA 510K clearance and will be marketed in the US. Since Medicare and Medicaid will no longer pay for preventable Surgical Site Infections (SSI), products like the Stryker antimicrobial catheter will become a critical tool for the medical profession, said Paul Ford, chief executive officer of Agion Technologies. This partnership is another innovative application of our powerful, natural technology, and sets a standard for the industry to follow.
Thu, 18 Dec 2008 07:00:00 +0100 EDAP announced that it has filed a 510(k) marketing application with the U.S. Food and Drug Administration (FDA) for its newly designed, high-end Sonolith I-Sys device.Sonolith I-Sys is a novel, robotized device with the potential to become the comparative assessment benchmark of next-generation lithotripsy devices. The integrated lithotripter utilizes EDAP's patented electroconductive technology, an advanced shockwave approach that is unique to successfully disintegrating urinary stones in association with combined x-ray or ultrasound systems.
Thu, 18 Dec 2008 07:00:00 +0100 Neuralstem has announced this morning that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a clinical trial to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The Company is planning to treat ALS patients through spinal injections of its stem cells via its patented Human Neural Stem Cell technology. Like all first human trials, this proposed trial is primarily designed to test the safety and feasibility of both our stem cells and our method of delivering the cells to the spinal cord in ALS patients, said Neuralstem CEO and President, Richard Garr. We are also proposing secondary endpoints which we hope will be able to measure a slowing down of the degenerative process.
Thu, 18 Dec 2008 07:00:00 +0100 IMRIS announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's 3 Tesla IMRISneuro for sale in the U.S. IMRISneuro is now available with either a 1.5 Tesla (1.5T) or a 3 Tesla (3T) magnet. Both systems provide IMRIS' patented technology and utilize 70 cm wide bore advanced magnetic resonance imaging systems from Siemens. The 3T IMRISneuro provides higher quality advanced imaging techniques for surgical planning such as diffusion tensor imaging (DTI), functional MRI and spectroscopy as well as superior quality vascular imaging in a robust platform specifically designed for use in an operating room. This additional system provides hospitals with more choice to meet the unique and growing needs of intraoperative and interventional imaging.
Wed, 17 Dec 2008 07:00:00 +0100 SilkRoad technology, a leading provider of talent management solutions, announced today they have received their completed SAS 70 Type II report. The receipt of this report confirms that SilkRoad is in compliance with SAS 70 recommended best practices to ensure the confidentiality, integrity, and availability of SilkRoad technology's systems and data.This completed report has become a requirement of outside vendors for most companies in the banking, healthcare, and high-tech industries. Companies in other industries are following suit as well, requiring that any organizations they work with provide proof, in the form of a SAS 70 Type II report, that they are following SAS 70 recommended best practices for protecting data.
Wed, 17 Dec 2008 07:00:00 +0100 Breach Security announced that Ochsner Health System has selected Breach's WebDefend as its solution of choice for identifying web application defects and securing its websites from attack. The Ochsner Health System includes seven hospitals and more than 35 health centers, employing more than 11,000 employees system-wide. Ochsner continuously meets the ever-changing patient and community needs through electronically linked hospitals and health centers. Electronic medical records are available from any Ochsner location, which allows for consistent patient care. As such, Ochsner selected WebDefend to protect its web applications, and to safeguard the private health information of its patients and employees as the organization expands its use of web applications.
Wed, 17 Dec 2008 07:00:00 +0100 St. Joseph's Hospital and Medical Center, Phoenix, announced that it is planning to use the state-of-the-art Clinical InfoNET videoconferencing system to connect specialist physicians at the hospital to referring physicians within the community. This program will include the Barrow Neurological Institute, as well as other key service lines at the hospital.With the objective of further enhancing patient care and service, the hospital selected Clinical InfoNET to increase direct face-to-face communications between the consulting physician specialists at the hospital and those physicians in the surrounding community who refer their patients to St. Joseph's.
Tue, 16 Dec 2008 07:00:00 +0100 Synerx Pharma, LLC announced the submission to the FDA of Isosulfan Blue Injection (generic equivalent to Lymphazurin, Covidien (formerly US Surgical)). This ANDA submission is the culmination of a four year joint effort by Synerx Pharma, LLC and its exclusive raw material supplier Apicore, LLC. According to Synerx Pharma and Apicore, the active ingredient is extremely difficult to synthesize. Synerx Pharma stated that this product fits nicely into their Company's strategic direction; it is a difficult to produce product, serves a critical medical need, and represents an unmet market need.
Tue, 16 Dec 2008 07:00:00 +0100 Catbird, the pioneer in comprehensive security and compliance for virtual and physical networks, announced the launch of the Catbird Compliance Enforcer, a free service that instantly validates and enforces the security and compliance of virtual data centers. Unlike passive auditing tools, the Catbird Compliance Enforcers automated VM quarantine technology brings a level of protection to VMware commensurate with industry regulations and critical to passing traditional audits. The Compliance Enforcer conducts a rapid analysis of all virtual machines, virtual networks and the hypervisor management network itself, immediately quarantining questionable machines and traffic and generating reports on anomalous conditions in violation of established regulations.
Tue, 16 Dec 2008 07:00:00 +0100 Dechra Veterinary Products announced that the company has received FDA approval to market VETORYL Capsules.VETORYL Capsules contain the drug trilostane, which has been demonstrated to be effective in the treatment of Cushing's syndrome in dogs. VETORYL will be indicated for use in pituitary-dependent hyperadrenocorticism, which comprises the majority of cases of Cushing's syndrome in dogs. Additionally, VETORYL has received designation status as a Minor Use Drug for treatment of hyperadrenocorticism caused by adrenal tumors -- the first drug to receive an approval for this indication and the first drug to receive a Minor Use designation in dogs.
Tue, 16 Dec 2008 07:00:00 +0100 Emergisoft Corporation has announced the release of EmergisoftED's latest version, 5.1, complete with new features designed to improve patient safety and to streamline clinical workflow. The newest version of EmergisoftED is also a CCHIT Certified 08 Emergency Department EHR. Certified Emergency Department Information Systems (EDIS) are new products that are fully certified once their operational use at an Emergency Department has been verified. EDISs are designed to automate and streamline workflow and provide patients with more efficient and improved quality of care in the Emergency Department (ED).
Mon, 15 Dec 2008 07:00:00 +0100 R.R. Donnelley & Sons Company announced that its 725,000 sq. ft. facility in Lynchburg, VA has been recommended for recertification to OSHA's Voluntary Protection Program (VPP) Star Status. Created in 1982, OSHA's Voluntary Protection Programs recognize and collaborate with businesses and worksites that show excellence in occupational safety and health. We believe that safety is the first and most important measure of operational excellence, said John Paloian, RR Donnelley's Chief Operating Officer. We are extremely proud of our employees' exceptional teamwork, innovation and attention to safety as reflected by VPP Star Status.
Mon, 15 Dec 2008 07:00:00 +0100 Consero Global Solutions has unveiled its SOX Compliance Service, helping companies implement controls and reporting requirements to meet the standards of the Sarbanes-Oxley (SOX) Act. Consero Global Solutions provides the expertise and methodology to drive and maintain compliance all at a 50-60 percent cost savings over local resources. SOX was enacted in 2002 to help improve quality and transparency in financial reporting. The main wave of SOX compliance activities has largely ended, leaving public companies focused primarily on maintaining their SOX compliance status. Companies in a dynamic business environment typically find these ongoing maintenance and audit activities require significant time and resources to accomplish. For companies who want to go public, becoming SOX compliant is simply a laborious and expensive effort. Both of these scenarios require a service provider with the right experience and methodology to execute effective and timely compliance activities fro
Mon, 15 Dec 2008 07:00:00 +0100 Meridian Knowledge Solutions, LLC isimplementing the software-as-a-service (SaaS) version of itslearning management system (LMS)for The University of Texas Health Science Center at Houston to manage anarray of compliance training. The university's 7,200 users will haveaccess to the Meridian LMS, also known as the Training & Resource Center(TRC), via a password-protected web site accessible through laptop anddesktop computers as well as PDAs. Our users not only possess a wide range of computer skills but also havevarying amounts of time for training. So we wanted a training system thatwas user friendly, adds Megan Williford, the Training & Resource Center(TRC) system administrator for The University of Texas Health ScienceCenter at Houston. Some workers simply want to get into the system, taketheir training and get out. Others want to explore learning opportunities.In either case, we wanted them to be able to access training with a fewclicks.
Mon, 15 Dec 2008 07:00:00 +0100 Healthcare Scouts, a national leader in recruiting and permanent placement of licensed healthcare professionals, based in Maitland, FL, has recently partnered with the continuing education provider, www.AAACEUS.com, of Denver, CO. www.AAACEUS.com is one of the first national online educational services to offer continuing ed for multiple certifications to the nursing, social work, case management and rehabilitation communities. Healthcare Scouts is happy to be adding this valuable educational service to its website, at a discounted rate, and chose www.AAACEUS.com because of their comprehensive and innovative approach to online continuing education.
Mon, 15 Dec 2008 07:00:00 +0100 The commentary below is authored by Darrell Duffie, the Dean Witter Distinguished Professor of Finance at the Stanford Graduate School of Business, based on his testimony before the U.S. Senate Committee on Banking, Housing, and Urban Affairs, on Reducing Risks and Improving Oversight in the OTC Credit Derivatives Market, July 14, 2008. It appears in the current edition of Stanford Knowledgebase, the free monthly information source for thoughts, ideas and research at the Stanford Graduate School of Business.
Sun, 14 Dec 2008 07:00:00 +0100 Vetted Internationals newly heightened security further protects its online file access from web fraud. An application upgrade to its existing web file access program Vetted QuickBase includes comprehensive security advancements pursuant to its existing policy to protect individually identifiable health information and the system components that such data resides in under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the security and privacy regulations implementing HIPAA, other federal and state laws protecting confidentiality of health information, professional ethics, and accreditation requirements.
Fri, 12 Dec 2008 07:00:00 +0100 NetWrix Corporation, a provider of systemsmanagement and compliance solutions for Active Directory and virtualizationenvironments, announced Version 2.0 of its Change Reporter for VMwareInfrastructure 3. Version 2.0 features regulatory compliance as well ascomplete support for major compliance regulations in the industry,including SOX, HIPPA, GLBA and FISMA. This expanded capacity marks thefirst time that any software in its class has been able to attain such athreshold in regulatory compliance standards for VMware environments, whichfurther solidifies NetWrix's expanding role in the surging systemsmanagement and compliance arena.
Thu, 11 Dec 2008 07:00:00 +0100 FDA Patient Safety News, the FDA's monthly video series for health care professionals, has won the Cheers Award from the Institute for Safe Medication Practices (ISMP) for efforts to improve the safe use of medical products and prevent medical errors. The ISMP Cheers Awards honors organizations that have set a superior standard of excellence for others to follow in the prevention of medication errors and adverse drug events.
Thu, 11 Dec 2008 07:00:00 +0100 Today, the U.S. Food and Drug Administration announced that it will add a Boxed Warning to the prescription oral sodium phosphate products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy (a type of acute kidney injury). Patients routinely take OSP products to cleanse the bowel before a colonoscopy (colon examination) and other medical procedures. The FDA has also directed the manufacturer of these products to develop a risk evaluation and mitigation strategy (REMS), distribute a Medication Guide to alert patients to the risk of acute kidney injury associated with the use of these products, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with the use of these products.
Thu, 11 Dec 2008 07:00:00 +0100 A checklist that ensures the proper functioning of a machine guarding device is among the products developed through an Alliance recently renewed between the Occupational Safety and Health Administration (OSHA) and the Association for High Technology Distribution (AHTD) to protect machine operators. The association created the Sample Light Curtain Check-Out Log that lists inspection items such as verifying that additional guarding devices, interlock switches and mechanical barriers are installed and operating properly. In addition, AHTD Implementation Team members presented 10 machine guarding training seminars to OSHA staff nationwide. The seminars provided technical information about the use of machine guarding devices and robotics in the workplace.
Thu, 11 Dec 2008 07:00:00 +0100 Doctations and Intelligent Medical Objects announced they have partnered to offer IMO's clinical terminologies through Doctations' online medical system. Doctations EHR is a unique true Internet-enabled, multi-tenancy healthcare software as a service designed to improve collaboration among doctors and patients. IMO is the leader in clinical interface terminology. By linking common medical terminology to standardized clinical codes, IMO's Problem improves a user's ability to find clinically relevant terms and their associated administrative codes, instantly improving any system that utilizes ICD-9-CM data.
Thu, 11 Dec 2008 07:00:00 +0100 Application Security, provider of database security, risk and compliance solutions for the enterprise, today announced the findings of its Database Security Controls survey with analyst firm Enterprise Strategy Group. While 58% of respondents reveal that the largest percentage of confidential data is located in the database, 54% note that a lack of internal processes and controls hinder the effectiveness of their database security efforts. A key indicator that enterprise organizations experience major gaps in protecting sensitive data is exposed by the finding that more than half of the respondents suffered a confidential data breach within the past 12 months.
Thu, 11 Dec 2008 07:00:00 +0100 Skybox Security has announced that it has joined the PCI Security Standards Council as a new participating organization. As a Participating Organization, Skybox Security will work with the Council to evolve the PCI Data Security Standard (DSS) and other payment card data protection standards. Skybox is the first and only network compliance and assurance vendor to support the PCI DSS V1.2 standard released in October. Through its participation, Skybox aims to the advance the automation of assessments and compliance processes for network-related PCI requirements - some of the most difficult for enterprises to enforce due to high complexity and labor costs. The PCI DSS, endorsed by American Express, Discover Financial Services, JCB International, MasterCard Worldwide and Visa Inc., requires merchants and service providers that store, process or transmit customer payment card data to adhere to information security controls and processes that ensure data integrity. More information on the c
Thu, 11 Dec 2008 07:00:00 +0100 Verizon Business' Professional Services Will Enable Certification of Monext's Processing System Monext France (formerly Experian), a pioneer of e-commerce transactions, has entrusted Verizon Business Security Solutions to help the company's online bank-payment processing system meet industry standards for protecting confidential data. Verizon Business provides professional services support and expertise to obtain Payment Card Industry Data Security Standard (PCI DSS) certification for Monext's processing system, Payline.
Wed, 10 Dec 2008 07:00:00 +0100 China Energy Recovery, pioneer in the waste heat energy recoverysector of the alternative energy industry, announced today that the companyhas initiated its efforts to comply with Section 404 of the Sarbanes-Oxley Actof 2002 (SOX 404) which requires annual management assessments of theeffectiveness of the company's internal controls over financial reporting anda report by its independent auditors attesting to management's assessments.CER has gathered necessary resources dedicated to the efforts and aims tosatisfy SOX 404 requirements for the fiscal year ending December 31, 2009. As a publicly traded company in the US, CER places high emphasis onstrengthening internal controls over financing reporting according to SOX404, said Mr. Qinghuan Wu, CER's Chief Executive Officer. We don't takethis as merely a piece of compliance work, but also value it as an opportunityto further improve our business practices, management systems and quality ofour financial reporting in order to enhance shar
Wed, 10 Dec 2008 07:00:00 +0100 Kinaxis, provider of the on-demand RapidResponse service that empowers multi-enterprise manufacturers with the collaborative and integrated demand-supply planning, monitoring, and response capabilities required in today's complex and dynamic world, today announced that it recently completed its first examination in conformity with Statement on Auditing Standards No. 70 (SAS 70), for the period May 1, 2008 through October 31, 2008. This widely recognized audit standard can help Kinaxis customers and their auditors to address the requirements of Sarbanes-Oxley. Completion of the SAS 70 Type II examination indicates that selected Kinaxis processes, procedures and controls for its on-demand RapidResponse service have been formally evaluated and tested by an independent accounting and auditing firm. The examination included controls related to organization and administration, logical and physical access, backup controls, change management and incident management.
Wed, 10 Dec 2008 07:00:00 +0100 Nebraska Methodist Hospital began using SciHealth's Insight to track compliance of core CMS Heart Failure quality measures including: discharge instructions, evaluation of left ventricular function, ACE/ARB of left ventricular systolic dysfunction and smoking cessation. As a result of their efforts, beginning in 2004, Methodist improved their compliance of key measures by 82% -- beginning with a compliance rate of 17.2% and finishing at 100% by August 2008. The rises in these scores highlight Methodist's commitment to improving heart health. CMS core measures have a direct impact on decreased mortality rates and decreased readmission rates for Heart Failure patients.
Wed, 10 Dec 2008 07:00:00 +0100 Information Builders has announced that numerous healthcare organizations are using WebFOCUS and iWay Software to bill for more revenue, reduce costs, and gain better visibility into operations to improve patient care. Information Builders has seen more than 100 percent growth in its healthcare business in 2008. Hospitals today maintain an immense amount of information that must be carefully stored, analyzed, and exchanged. NYU Langone Medical Center, Mount Sinai Hospital, Jefferson Regional Medical Center, University of Virginia Department of Medicine, Clarian Health, and others have selected Information Builders to streamline the flow of this information and to track financial, clinical, and operational performance.
Wed, 10 Dec 2008 07:00:00 +0100 Markel Corporation is pleased to announce the launch of DataBreach(SM), its new information risk and privacy liability insurance product. DataBreach(SM) helps businesses manage risk associated with their reliance on information technology systems as it relates to confidential information in their custody or care. DataBreach(SM) was created in response to the increase in identity theft that has been plaguing businesses worldwide in the past few years. It provides coverage for liabilities arising out of the breach of a company's duty to protect confidential information, whether it's on their website, network, the hard drive of a laptop, or in a paper file. The coverage also extends to a businesses liability arising out of an employee's misuse of his/her access to confidential information.
Wed, 10 Dec 2008 07:00:00 +0100 Synygy, a recognized authority in sales performance management (SPM) and the most experienced provider of sales compensation management (SCM) solutions, today announced the successful completion of an independent third-party audit attesting to the company's adherence to Health Insurance Portability and Accountability Act (HIPAA) standards for privacy of individually identifiable health information. HIPPA standards require that healthcare providers and healthcare clearinghouses assure the integrity and confidentiality of electronic information that is collected and stored. As the company with the highest SCM market share in the pharmaceutical and healthcare information technology sectors, Synygy places the utmost value on guardianship of their clients' confidential data. In so doing, Synygy engaged an independent external reviewer, SunGard Availability Services, to conduct an overall enterprise security assessment as part of Synygy's annual audit examinations.
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