Healthcare Industry News:  neuromodulation 

Devices Monitoring

 News Release - January 19, 2010

St. Jude Medical Achieves Recognition for Security of Patient Data and Completes Successful Testing to Streamline Connection to Patient Medical Records

St. Jude Medical is the first medical device manufacturer to achieve ISO 27001 certification of its patient care network, and is also the first to successfully complete a second IHE Connectathon testing process

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced it has successfully completed its second interoperability testing process for the company’s Merlin.net™ Patient Care Network, an Internet-based repository of patient and implantable device data. The company also announced today that the Merlin.net PCN is the first medical device network to be awarded ISO 27001 certification, a stringent worldwide information security standard.

“Due to recent legislation and the changing health care environment, electronic health records (EHRs) and hospital efficiency are key issues for our customers. As the use of EHRs become central to healthcare delivery and quality, secure data transportability is becoming even more critical and as a result, connectivity is a key priority for our company,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “Receiving recognition from these two organizations demonstrates to our medical industry stakeholders the high standards St. Jude Medical has set for both the security and efficiency of our patient care network.”

ISO 27001 Certification

BSI Management Systems, an international standards, testing, registration and certification organization, has awarded St. Jude Medical the information security certification ISO/IEC 27001:2005. This ISO certification recognizes that St. Jude Medical’s Merlin.net PCN has established processes and standards that maintain the strictest levels of confidentiality, integrity and availability for its customers. The Merlin.net PCN is the first CRM device data network to be recognized with this certification.

ISO/IEC 27001:2005 is an information security management system (ISMS) standard, published in October 2005 by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It has become the gold standard in information security across a broad range of industries, with 96 U.S. companies earning certification. The standard specifies the methodology to enable a business to establish, implement, operate, monitor, review, maintain and improve effective information security.

ISO is the world's largest developer and publisher of international standards. It is a non-governmental network of national standards institutes of 157 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. IEC is a not-for-profit, non-governmental international standards organization, also headquartered in Geneva, Switzerland, that prepares and publishes International Standards for all electrical, electronic and related technologies. It currently has over 130 member countries.

IHE Connectathon

During the week of Jan. 11, St. Jude Medical participated in the IHE (Integrating the Healthcare Enterprise) Connectathon testing of the Implantable Device Cardiac Observation profile. This testing demonstrated the ability for the Merlin.net PCN to connect to third-party EHR systems using defined industry standards. Support for this profile allows physicians and hospitals to seamlessly share data from one system to another, thereby increasing productivity, providing tools for improved clinical decision making and quality of care, and eliminating redundant medical device management systems.

In 2007, St. Jude Medical was the first manufacturer of CRM devices to test a product for conformance with an IHE interconnectivity profile. This year, St Jude Medical became the first Cardiac Rhythm Management vendor to successfully complete Connectathon testing of the Implantable Device Cardiac Observation (IDCO) profile for a second time. In this round of testing, St. Jude Medical connected with EHR vendors including Epic, General Electric, NextGen and Medical Micrographics.

The testing process, established by the IHE, is an initiative promoting the adoption of standards that enable healthcare information to be shared seamlessly across clinical settings. The testing took place during the annual IHE Connectathon in Chicago. The organization’s goal is to drive standards for interoperability, increasing efficiency and reducing cost to healthcare customers, such as those in the cardiology, radiology and laboratory markets.

About the Merlin.Net Patient Care Network (PCN)

Implantable cardiac devices are designed to capture and record information about device performance and patient heart rhythms that is vital to patient care. Merlin.net PCN organizes this information for fast analysis and easy review and allows data to be sent directly to a clinic's or a hospital's EHR system so the data are included in the patient’s comprehensive personal health record.

With immediate access to patient information through the secure Merlin.net PCN website, physicians can remotely monitor and assess patient device data and determine the level of care needed. Alert notification delivery times can be customized to fit in with physician determined clinic hours, including any after-hours processes the clinic might provide.

In addition to meeting the ISO/IEC 27001:2005 standard, the Merlin.net PCN system adheres to patient privacy standards and requirements for the electronic transmission of health information, as set forth by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

The Merlin.net PCN was recognized as a silver winner of the 2009 Medical Design Excellence Awards, an award competition that is organized and presented by Canon Communications LLC and is the only awards program that exclusively recognizes contributions and advances in the design of medical products.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Quarterly Reports on Form 10-Q for the fiscal quarters ended April 4, 2009, July 4, 2009 and October 3, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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