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Remote monitoring system for implantable cardiac devices receives FDA approval

St Jude Medical : 13 May, 2008  (New Product)
St Jude Medical has received US FDA approval of the next-generation Patient Care Network (PCN), an Internet-based central repository for patient device data gathered at the time of implant procedures, at in-clinic follow-up visits or from patient-initiated remote follow-up appointments.
The next-generation PCN Version 3.0 includes an automated interactive voice response feature, DirectCall Message, which clinics can use to make routine telephone calls to patients.

The DirectCall Message automated system can call patients to remind them of upcoming remote follow-up appointments, or to notify them if they miss a remote follow-up appointment. DirectCall Message also can be used to ask patients to call the clinic, or to inform patients that their remote transmissions have been reviewed by the clinic and the results look normal.

DirectCall Message does not replace office visits or reduce contact with physicians. However, it is expected to reduce the number of routine calls usually made by clinic staff, while making sure that patients receive important reminders and notifications. It is intended to reduce clinics' administrative burdens and increase efficiencies.

'The next-generation PCN helps physicians enhance patient care while improving their administrative efficiency,' said Eric S Fain, MD, president of the St Jude Medical Cardiac Rhythm Management Division. 'Seamless, secure data transfer, along with DirectCall Message, free up time that can now be spent dealing with more critical patient needs.'

St Jude Medical is the only cardiac rhythm management company able to transfer information directly from the remote care system to a patient's electronic health record using the requirements established by the IHE (Integrating the Healthcare Enterprise), which promotes standards for securely sharing healthcare information across clinical settings. Meeting these standards helps make the transfer of patient data from PCN to the clinic's electronic health record (EHR) system seamless and secure. PCN's integration with hospitals' and clinics' EHR systems has been enhanced through an exclusive partnership with Healthvision, whose healthcare-specific software and services allow clinics and hospitals to integrate data regardless of the type of data or the format in which it exists. The partnership allows St Jude Medical to work with more clinics and hospitals, helping them to improve business workflow and operational efficiencies, and to better manage the health of their patients.

With both IHE and Healthvision as tools to achieve interoperability for its customers, St Jude Medical offers direct connections to an expanding pipeline of major EHR systems, including GEMMS, eMedApps, Lumedx and Medical Informatics Engineering, and is expanding its integration with other systems. Its commitment to patient data management reflects the growing importance of EHRs in everyday clinic administration.

'Electronic Health Records are becoming a necessary and useful part of our clinical lives,' said Scott Hessen, MD, chief, clinical cardiac electrophysiology, Cardiology Consultants of Philadelphia. 'The interoperability offered by PCN will help us integrate patient data more easily, giving us complete health profiles of our patients and a basis for better treatment decisions that can improve patient outcomes and reduce costs.'

When dealing with electronic patient information, privacy is a significant concern for physicians and patients. The entire PCN system, from user access to data storage, meets the standards of reliability, privacy and security established by regulatory requirements and by the International Quality Certification Standards. All network communications that occur on PCN are encrypted with the highest level of protection using industry standard cryptography. To ensure that no unauthorised viewers can access patient data while the Web site is in use, all access to PCN is password protected and any suspicious activity is monitored.

'Because security and privacy are so important, the PCN system security is subject to regular assessments by independent, third-party computer security specialists,' said Fain. 'We work continually to keep security and privacy protection standards updated. We want our customers, and their patients, to be confident in our commitment to ensure PCN remains effective, efficient, protected and secure.' PCN 3.0 will be featured at Heart Rhythm 2008, which takes place May 14 to 17, 2008 at the Moscone Convention Center in San Francisco, USA.
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