Protecting Patient Personal Health
Monday 29 October,
| Room 6B
Electronic interactions between healthcare system participants, consumers, patients and government organizations introduce additional personal health information risks as well as benefits. Some risks using paper documents and electronic versions are consistent, such as the potential for compromised data and identify theft, but information networks introduce the additional risks of global accessibility to electronic data and rapid reproducibility of stolen private patient information. New risks, such as software malware and network-based attacks on medical devices and health information technology systems, bring potential safety and efficacy impacts as well as financial risk. While many believe healthcare information privacy regulation begins and ends with HIPAA, FDA also is concerned about proper management of this risk. Software applications that are part of or interact with a medical device must provide reliable interoperability to share information while maintaining patient safety and data privacy. Since these interconnected systems will include government organizations, they must also provide adequate security against malicious users while reliably performing their intended function.
After this session participants should be able to:
- Incorporate patient privacy and security into their organization’s FDA regulatory compliance strategy.
- Identify the applicable medical device regulations FDA uses to oversee medical device security.
- Discuss standards that apply to medical device data security and interoperability with health information systems, and new policy initiatives specifically targeting medical device security that will impact regulatory in the future.
- Identify cyber security risks and develop risk mitigation activities for medical device data security and privacy into their company’s product and enterprise risk planning efforts.
- Incorporate appropriate security measures for exchanging information with FDA.
||Colleen Hittle, RAC, president and CEO, Anson Group
||Brian Fitzgerald, deputy
director, Division of Electrical and Software Engineering, OSEL, CDRH, FDA
Kevin Fu, PhD assistant professor, UMASS Amherst
Dale F. Nordenberg, MD, executive
director, Medical Device Innovation, Safety and Security Consortium (MDISS) and
president, Novasano Health and Science