Author: Julie Kaloides

NASHVILLE, TN—Clearwater, the leading provider of Enterprise Cyber Risk Management and HIPAA compliance software and consulting services for the healthcare industry, announced today that Executive Chairman Bob Chaput will be among the keynote speakers at the Cylera HIoT Security Executive Summit, taking place in Miami Beach, FL, October 17-18.
Designed to foster collaboration and innovation for the future of medical device security and patient safety, the invitation-only thought leadership summit will bring together Chief Information Officers (CIO) and Chief Information Security Officers (CISO) from several leading health systems across the country. Medical device security continues to be a major source of concern for the healthcare industry as the U.S. Food and Drug Administration and Department of Homeland Security issued a new warning on October 1 about cybersecurity vulnerabilities in operating systems that power a variety of medical devices¹.
Mr. Chaput’s address, titled “First, Do ‘Know Harm’,” will discuss the growing potential for patient harm due to the compromise of healthcare data, systems, and devices. He will discuss the regulatory requirements and enterprise risk management need for hospitals and health systems to take a more comprehensive and integrated approach to identifying, managing, and reducing cyber risk across the evolving healthcare IT ecosystem.
“The explosion of data, devices, and systems that are supporting healthcare delivery has created the unintended consequence of greater risk — risk not only of protected health information being exposed but also of care not being as accessible or as safe as we need it to be,“ Chaput said. “Patient lives may be at risk, for example, when a ransomware attack disrupts the availability of data and a provider is unable to deliver services. The first step in addressing cyber risk is engaging in a conversation about what cyber risks exist, the potential impacts to patients, and the steps that can be taken to develop a strong Enterprise Cyber Risk Management program.”
A leader who has a unique view of healthcare cybersecurity innovation, Mr. Chaput has been responsible for the associated regulatory compliance and security of some of the world’s largest healthcare networking and computing infrastructures over the course of his nearly 40-year career. He founded Clearwater in 2009 to help healthcare organizations gain a full understanding of all of their cybersecurity risks; that is, all the ways in which there can be a compromise of the confidentiality, integrity, and availability of any of their healthcare data, systems, and devices.
About Clearwater
Clearwater is the leading provider of Enterprise Cyber Risk Management and HIPAA compliance software and consulting services for the healthcare industry. Our solutions enable organizations to gain enterprise-wide visibility into cybersecurity risks and more effectively prioritize and manage them, ensuring compliance with industry regulations. Clearwater’s IRM|Pro^® software and consulting services help healthcare organizations to avoid preventable breaches, protect patients, and meet OCR’s expectations, while optimizing cybersecurity investments. More than 400 healthcare organizations, including 60 of the nation’s largest health systems and a large universe of business associates that serve the industry, trust Clearwater to meet their information security needs. For more information about Clearwater, please visit www.clearwatercompliance.com.
¹ https://news.bloomberglaw.com/tech-and-telecom-law/u-s-warns-cybersecurity-flaws-could-impact-medical-devices

Dayton, OH—LOT Cargo, a leading carrier with cargo transports to, from, and within Europe, recently signed a Master Lease Agreement with CSafe Global for temperature-controlled active containers to address the crucial cold-chain transport needs of life-science companies.
LOT Cargo, a leading carrier with cargo transports to, from, and within Europe, recently signed a Master Lease Agreement with CSafe Global, the innovation leader in active temperature-controlled air cargo containers, to extend cold-chain transportation offerings to their life-science customers who ship temperature-sensitive and life-enhancing products to patients around the globe.
“This is big step in our LOT Polish Airlines history,” says Michal Grochowski, LOT Cargo Director. “We are proud that we can cooperate with one of the best and the most innovative global companies that provide cold-chain solutions to pharmaceutical customers, and are confident that we will be able to develop this business relationship to further benefit our valued customers with best-in-class active containers.” — he added.
“We are very excited to add LOT Cargo to our extensive list of airline partners who have enhanced their pharma program by offering our innovative CSafe RKN and CSafe RAP active systems”, states Brad Jennings, VP of Global Marketing.” LOT Cargo’s strong network, with direct links between the key markets of Europe with the US, Asia Pacific and India, paired with the superior performance of CSafe’s active container range, will provide LOT’s pharma customers with the ultimate air cargo solution for their temperature-sensitive supply chain. We certainly look forward to a mutually beneficial partnership with LOT Cargo as we continue to deliver on our promise of protecting what matters most to pharmaceutical companies, so that patients can receive what matters most to them.”
The CSafe RAP and CSafe RKN active temperature-controlled containers offer unmatched operational capabilities, boasting the industry’s longest battery run times and broadest ambient temperature operating ranges (-30°C to +54°C for the CSafe RAP, and -30°C to +49°C for the CSafe RKN). CSafe’s innovative system design combines advanced compressor-driven cooling technologies with superior VIP insulation to regulate payload temperatures precisely where they need to be.

Franklin, Ind.,/PRNewswire/—G&H Orthodontics is excited to announce that Charles (Charlie) Wemhoffhas joined G&H Orthodontics as Vice President of Operations.
Mr. Wemhoff brings extensive medical device industry experience with a strong background in lean manufacturing and plant and supply chain management in both domestic and international markets. Prior to joining G&H Orthodontics, Mr. Wemhoff served in various executive and operations leadership roles over the last 20+ years at Viant Medical, Integer, Metaldyne Inc. and ArvinMeritor. At G&H, Mr. Wemhoff will lead manufacturing, fulfillment, distribution and all operations supporting the Company’s global markets.
“Under Charlie’s direction, we will better leverage our cross-functional expertise and optimize our production capacity to drive and support new and incremental business growth for our customers,” noted John Voskuil, CEO of G&H Orthodontics. “In addition, we will continue to advance our overall manufacturing and distribution capabilities and competencies to best serve our customers.”
Mr. Wemhoff shared, “I am excited to join such a strong global operation that does so much to support its customers all over the country and the world. I look forward to optimizing G&H operations to better serve and grow our customers’ businesses while expanding our capabilities and advancing our business.”
About G&H Orthodontics
G&H Orthodontics, Inc. is a leading provider of clinical solutions for the orthodontic community serving customers for over 40 years in over 90 countries. G&H^® is the manufacturer of a full line made in the U.S.A. including brackets, bands, tubes, wires, springs, elastomeric and other orthodontic supplies. G&H is compliant with the U.S. FDA, ISO 13485:2003, Medical Device Directives, 93/42 EEC and Canadian Medical Device Guidelines which ensures availability of products worldwide. G&H Orthodontics is a privately held company headquartered in Franklin, Indiana.

DAYTON, OH—CSafe Global, a leading provider of active and passive temperature-controlled packaging solutions for pharmaceutical products, is pleased to announce that American Airlines Cargo, one of the industry’s leading air cargo brands, has approved the recently launched CSafe RAP for flight.
CSafe Global, the innovation leader in active temperature-controlled container solutions for the transport of life-enhancing pharmaceuticals, is pleased to announce that Lufthansa Cargo is the latest airline to qualify and approve the CSafe RAP for flight.
Lufthansa Cargo has approved the CSafe RAP for transport on their extensive network of airlines, serving over 300 destinations in more than 100 countries worldwide. The strong performance and unmatched thermal protection of the CSafe RAP is quickly attracting attention and gaining approval to fly on airlines around the world.
Thorsten Braun, Senior Director of Industry Development & Product Management says, “To me it represents a typical win-win situation. With the addition of the CSafe RAP we are further expanding our portfolio of active cool containers, which is second to none, while intensifying our existing relationship with CSafe. In combination with our extensive global network, we are offering one of the leading cool containers to our customers!” Jeff Pepperworth, Chief Executive Officer for CSafe Global states, “We’re excited to add Lufthansa Cargo to our expansive network of airline partners approved to fly the CSafe RAP. We are honored to deepen our relationship with Lufthansa Cargo and strengthen our promise to protect what matters most to pharmaceutical customers so that patients can receive what matters most to them.”
The CSafe RAP represents CSafe’s dedication to quality, ensuring the temperature integrity and safe delivery of temperature-sensitive, life-enhancing products across the globe. By utilizing CSafe’s proprietary ThermoCor^® VIP insulation together with an innovative cooling and heating system, the CSafe RAP precisely maintains a defined payload temperature set-point throughout product transport, even in the most extreme ambient conditions (-30°C to +54°C). This is the broadest operating range in the industry.
Customers seeking more information about any of the CSafe active temperature-controlled containers or their leasing options should visit www.csafeglobal.com.

Dayton, OH—CSafe Global, the innovation leader in active temperature-controlled containers for transport of life-enhancing pharmaceuticals, is pleased to announce that Swiss WorldCargo is the latest airline to qualify and approve the CSafe RAP for flight.
SWISS WorldCargo has approved the CSafe RAP for lift on their fleet of wide-bodied aircraft. The CSafe RAP is CSafe’s latest innovation in active temperature-controlled containers and has quickly gained approval to fly on an ever-expanding list of airlines. SWISS WorldCargo serves over 100 destinations all over the world from Zurich and Geneva, and this partnership will open several new lanes for the CSafe RAP.
Jeff Pepperworth, Chief Executive Officer for CSafe Global states, “Adding Swiss WorldCargo to our network of airline partners approved to fly the CSafe RAP certainly extends our ability to serve more life-science customers with this state-of-the-art air cargo container solution. We are proud to further our partnership with SWISS and believe the combination of our industry-leading solution with their pharma cargo service will go a long way to ensure that life-enhancing, temperature-sensitive products make it to patients in need around the world.”
Susanne Wellauer, Head of Pharmaceuticals and Healthcare Vertical Industry Management, adds: “Swiss WorldCargo is delighted to allow CSafe RAP containers on board our aircraft. Our partnership underscores not only a continued focus on quality in shipping temperature-sensitive pharmaceutical goods worldwide every day, but also our dedication to finding the best solutions for doing so.”
The CSafe RAP represents CSafe’s dedication to quality, ensuring the temperature integrity and safe delivery of temperature-sensitive, life-enhancing products across the globe. The CSafe RAP active container system leverages the proven performance and capabilities of the well-established CSafe RKN to remove any operational and environmental challenges encountered with temperature-controlled shipments. By utilizing CSafe’s proprietary ThermoCor^® VIP insulation together with an innovative cooling and heating system, the CSafe RAP precisely maintains a defined payload temperature set-point throughout product transport, regardless of ambient conditions.
Customers seeking more information about any of the CSafe active temperature-controlled containers or their leasing options should visit www.csafeglobal.com.

Clearwater is proud to announce that Executive Chairman Bob Chaput has been invited to be part of the faculty for a new professional certificate program offered by The University of Texas at Austin. Titled Leadership in Healthcare Privacy and Security Risk Management, the first-in-the-nation certificate is designed to help fill the acute need for a trained, non-technical workforce to protect healthcare systems across the nation from fast-evolving cybersecurity threats.
The global cybersecurity workforce will have more than 1.8 million unfilled positions by 2022. The University of Texas’ McCombs School of Business is helping to close this gap by collaborating with industry, healthcare organizations, and governmental agencies to develop leaders in healthcare privacy and cybersecurity through the launch of a focused professional education program. The development of the curriculum was co-led by Sri Bharadwaj, MS, CHCIO, CPHIMS, PMP, CISSP, who serves as Chief Information Security Officer and Director, Clinical and Business Applications for UC Irvine Health, and Leanne Field, Ph.D., Director of Digital Healthcare Innovation for the McCombs School of Business.
Running July 10th thru August 31st and following an executive-style schedule, the Leadership in Healthcare Privacy and Security Risk Management program provides students with the flexibility to take the class in-person in Austin, remotely via real-time distance education, or a combination of both.

Dayton, OH—CSafe Global, the innovation leader in temperature-controlled packaging solutions specifically designed to protect valuable life-enhancing pharmaceuticals, announces today that Seth Hertel has been appointed as its new Chief Commercial Officer.
CSafe Global, the innovation leader in temperature-controlled packaging solutions specifically designed to protect valuable life-enhancing pharmaceuticals, announces today that Seth Hertel has been appointed as its new Chief Commercial Officer.
“I am excited to welcome Seth, a healthcare veteran who comes to us with a wealth of expertise and experience gained from key executive sales leadership roles prior to accepting the CCO role with CSafe. Seth will lead our commercial efforts across the globe, and I fully expect that his contributions will go a long way in propelling CSafe to even greater heights,” said Jeff Pepperworth, Chief Executive Officer, CSafe Global.
Prior to joining CSafe, Mr. Hertel served as the Global Head of Sales for the pharmaceutical business unit at Roquette. Before that, he held global senior leadership roles with Sigma-Aldrich Corporation as well as Thermo Fisher Scientific.
“I am honored and especially excited by the opportunity to join this great company,” said Seth. “I look forward to working with Jeff, and the rest of the CSafe team, as we continue to serve and delight our biopharmaceutical and life science customers while leveraging best-in-class cold-chain solutions, and incredible customer service.”
For more information about CSafe Global or its vast portfolio of temperature management packaging solutions, please visit www.csafeglobal.com.

Dayton, OH—LATAM Cargo, a leading carrier to, from, and within Latin America, recently signed a Master Lease Agreement with CSafe Global, a leading provider of active and passive temperature-controlled packaging solutions, to extend alternative transportation options to its clients shipping temperature-sensitive pharmaceuticals.
LATAM Cargo, a leading carrier to, from, and within Latin America, recently signed a Master Lease Agreement with CSafe Global, a leading provider of active and passive temperature-controlled packaging solutions, to extend alternative transportation options to its clients shipping temperature-sensitive pharmaceuticals.
“Our top priority when shipping highly delicate and valuable cargo such as pharmaceutical products is to maintain the desired temperature levels throughout the entire time the cargo is transported, from the origin until its final destination. We understand that minimal deviation from the defined temperature ranges can greatly affect the quality of the products and that is why we are constantly evaluating new options for our Clients. CSafe containers offer cutting-edge technology that will continue to strengthen our PHARMA ACTIVE Product”, explains Product Development Senior Manager for LATAM Cargo, Rodolfo Marré.
The CSafe RAP and CSafe RKN active temperature-controlled containers expertly offer unmatched operational capabilities with the industry’s longest battery run times and broadest ambient temperature ranges of -30°C to +54°C for the CSafe RAP and -30°C to +49°C for the CSafe RKN. CSafe’s innovative system design combines advanced compressor-driven cooling technologies with superior VIP insulation to regulate payload temperatures precisely where they need to be for up to four US pallets of pharmaceutical product, per container. These active containers have approvals to fly on both the upper and lower decks of aircraft and are a welcomed addition to LATAM’s offering.
“We are very excited about the addition of LATAM Cargo to our roster of airline partners who have included the CSafe RKN and CSafe RAP active systems in their pharma offering” cites Brad Jennings, Vice President of Global Marketing and Partner Alliances with CSafe Global. “With a comprehensive cargo network serving key markets in the Latin American region, and a robust CEIV pharma program, we look forward to a very fruitful collaboration with LATAM Cargo as we collectively strive to best serve pharma companies seeking that ultimate peace of mind when transporting invaluable life-enhancing medications to their patients in the increasingly important pharma market across Latin America”.
Customers seeking more information about any of the CSafe active temperature-controlled containers or their leasing options should visit www.csafeglobal.com/product-solutions/active-solutions/.

Dayton, OH—CSafe Global, a leading provider of active and passive temperature-controlled packaging solutions for pharmaceutical products, is pleased to announce that Alitalia has approved the recently launched CSafe RAP for lift.
CSafe’s recently launched CSafe RAP is the latest innovation in large, active temperature-controlled containers to enter the pharmaceutical cold chain industry. Offering best-in-class operational performance, even in the most extreme ambient conditions (-30°C to +54°C), the CSafe RAP has quickly gained validation approval across the airline industry.
“We are proud to add Alitalia to our roster of airline partners approved to fly the CSafe RAP temperature-controlled system,” states Brad Jennings, Vice President of Global Marketing and Partner Alliances for CSafe Global. “With its state-of-the-art VIP insulation, innovative air recirculation system, and unique, autonomous temperature management programming, the CSafe RAP, in combination with Alitalia’s cargo service, ensures the safe delivery of temperature-sensitive, life-enhancing products to patients in need.”
The CSafe RAP has already successfully managed numerous temperature-sensitive and time-critical shipments around the world. With industry leading payload temperature protection for vital life-science shipments, CSafe is pleased to be able to offer Alitalia’s pharma customers added peace of mind.
Antonio Temporini, Vice President Cargo of Alitalia, said “There is increasing demand for transport of temperature-sensitive healthcare products preserving their quality and value, and this enhanced partnership further allows us to offer innovative solutions to healthcare shippers for the protection and the integrity of their shipments.”
Many of the same leasing options currently available for the proven CSafe RKN are also available for the new CSafe RAP. Customers may lease the CSafe RAP directly from Alitalia, or through one of CSafe’s other logistic partners.
Customers seeking more information about the CSafe RAP or their leasing options should visit www.csafeglobal.com/csafe-rap/.

NASHVILLE, Tenn.—(BUSINESS WIRE)—As the healthcare industry continues to be targeted by cyber attacks, Clearwater has released new, breakthrough technology that provides hospitals and health systems with a more intelligent view into all of the processes, people, locations, technology and components that can pose a data security risk to an information system. Clearwater’s new Component Expert System (CES), embedded in its IRM|Analysis™ software, enables hospitals and health systems to complete the security risk analysis (SRA) process more efficiently across the enterprise by logically grouping similar information system components based on their properties and associated controls. The patent-pending technology automatically identifies relevant cyber and information risk scenarios, thereby facilitating a more effective risk assessment process.
“For a large and complex hospital or healthcare system, it can be daunting to try to perform a comprehensive cyber risk analysis,” said Clearwater’s Jon Stone, senior vice president for Product Innovation. “IRM|Analysis™ with CES technology, offers health systems advanced decision support technology that provides them with a view of the entire threat surface, fully adapted to address the specific vulnerabilities and risk scenarios that are related to their specific technologies and systems.”
For context, the U.S. Department of Health and Human Services reported more than 400 hacks of health data systems in 2018, an increase of more nearly 25 percent. Despite the increasing threats, the most recent CHIME survey of healthcare leaders found only 16 percent reported having a fully functioning cybersecurity program. Many cite complexity as a barrier to completing a comprehensive cyber risk analysis.
By leveraging intuitive wizards, IRM|Analysis™ with CES further streamlines the investigative process, by adding a simple set of intuitive questions to identify the precise set of vulnerabilities, threats and controls that must be addressed in order to implement a comprehensive cyber risk management program.
Clearwater CEO Steve Cagle noted, “Effective data security always starts with a comprehensive risk analysis. Our CES technology takes cyber risk analysis to the next level. The advanced functionality of IRM|Analysis™ with CES creates a more accurate and efficient process of conducting an enterprise-wide risk analysis and gives hospitals and health systems the exact roadmap they need to immediately strengthen risk management and cybersecurity.”
IRM|Analysis™ has been deployed by hundreds of hospitals and health systems, and ensures appropriate identification of and response to high risks. It offers integrated workflow and dashboard reporting that facilitates management of critical risk remediation actions. IRM|Analysis™ helps hospitals and health systems to improve their security posture, optimize budgets and resources, and achieve HIPAA compliance by providing visibility to each organization’s cybersecurity exposures. IRM|Analysis™ meets all nine requirements of a Security Risk Analysis based on the Office for Civil Rights Guidance Publication. OCR has accepted Risk Analyses conducted with IRM|Analysis 100 percent of the time when performed in accordance or in conjunction with Clearwater’s recommendations and advice. CES is configured as an out-of-the-box enhancement to the IRM|Analysis™ software tool and is designed for fast and efficient installation to empower hospitals and health systems to quickly bolster their cyber risk management systems.
In addition to increasing the risk of a breach, an insufficient risk analysis may lead to OCR fines and reputational damage. In fact, 89 percent of OCR enforcement actions involving ePHI cite failure to perform a sufficient risk analysis as a primary deficiency. Leading healthcare organizations such as Sentara, Advocate, CHRISTUS, and Baptist Health South Florida, have solved these critical cyber risk challenges by implementing Clearwater’s IRM|Analysis software.
About Clearwater
Clearwater provides the most complete and trusted, enterprise-class cyber risk management solution available. Designed for healthcare providers and their partners, Clearwater’s IRM|Pro™ platform and experienced professional services team provide insights and actions to address compliance, cyber and patient safety risks. Clearwater is a 2017 Inc. 5000 fastest-growing company, the 2018 Best in KLAS winner in Cybersecurity Advisory Services, the 2017 and 2018 Black Book Marketing Research winner in Compliance and Risk Management Solutions, and endorsed by numerous state hospital associations. Clearwater solutions have been deployed within hundreds of hospitals and health systems, Fortune 100 organizations, and federal government institutions. More information about Clearwater is at clearwatercompliance.com.