Regulators and medical-device-makers are bracing for an expected barrage of hacking attacks even as legal and technical uncertainties leave them in uncharted territory . Tens of millions of electronic health records have been compromised Attack.Databreach in recent years , a number that is growing and , some say , underreported . High-profile attacks have hit hospitals and health insurers , and now attention is turning to a new vulnerability : medical devices like pacemakers and insulin pumps . The Food and Drug Administration ( FDA ) has become increasingly concerned about the issue and is working to coordinate with other agencies on how to respond if a serious medical device hack were to occur . There have been rumblings over cybersecurity for years . More than 113 million personal health records were compromised Attack.Databreach in 2015 , according to provider data reported to the Department of Health and Human Services ( DHS ) , nine times as many as in 2014 . Last fall , Johnson & Johnson had to tell Vulnerability-related.DiscoverVulnerability its customers that its insulin pumps had a security vulnerability that hackers could use to access the device and cause a potentially fatal overdose of insulin . `` In just the last few years , we 've seen more than a hundred million health records of American citizens breached Attack.Databreach in a couple of well-publicized incidents , '' Terry Rice , vice president of IT risk management and chief information security officer at Merck & Company , told the Energy and Commerce Oversight and Investigations Subcommittee last week .