3 ISAO participation reduces reporting requirements to the FDA considerably. From a legal standpoint, I would go so far as to say it reduces liability also, in the fact that it shows the manufacturers commitment to safety and negates any ill intent on the manufacturers part. BLOOMBERG BNA: How will the implementation of the recommended risk management programs by medical device companies impact their economic outlook? PRIVACY WATCH ISSN 0000-0000 YANNELLA: If done properly, using ISAO data sharing and the NIST Framework for improving critical infrastructure, the costs to a manufacturer should be reasonable. The increased security should increase the physician and patient confidence in the safety of medical devices and encourage greater use. As with all additional Quality Systems requirements, if integrated appropriately into the design and post market monitoring of the device, the economic impact should be no more than compliance with various sections of 21 CFR 820 for QSR, complaint handling, quality audit, corrective and preventive action, software validation and risk analysis and servicing and monitoring. Companies who have good Quality Assurance systems will have little additional cost or trouble implementing the new guidance recommendations. Yannella would like to thank Neil DiSpirito, of counsel Ballard Spahr, for his assistance. BNA 2-25-16 .