Resumen
Millions of patients benefit from programmable, implantable medical devices (IMDs) that treat chronic ailments such as cardiac arrhythmia, diabetes, and Parkinson's disease with various combinations of electrical therapy and drug infusion. However, the convergence of medicine with radio communication and Internet connectivity exposes these devices not only to safety and effectiveness risks, but also to security and privacy risks. Improving IMD security and privacy requires a proper mix of technology and regulation. Technological approaches to improving IMD security and privacy include judicious use of cryptography and limiting unnecessary exposure to would-be hackers. Premarket approval for life-sustaining IMDs should explicitly evaluate security and privacy. Legislators should mandate stronger security during premarket approval of life-sustaining IMDs that rely on either radio communication or computer networking. Legislators should give regulators the authority to require adequate privacy controls before allowing an IMD to reach the market