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Second, the FDA should be granted specific responsibility for the review of not only the medical safety and efficacy of CMD products, but their embedded ICT software as well, evaluating National Institute of Standards and Technology (NIST) SP 800-53-type security and privacy controls to assure the performance of their connectivity, appropriate limitations of device access and privacy of patient data collected and transmitted by the devices.

The Federal pre-emption concern raises three related paths to improvement that also offer good models for other connected consumer devices.įirst, states could pass statutes granting explicit jurisdiction to their state courts over cases involving failures of the ICT software in connected medical device products sold in their states. If the device fails because of a cyber security vulnerability leading to a hack, a security weakness permitting unauthorized tampering or other threat vector not reviewed by the FDA, the victim or his/her survivors may be left without a remedy if they do not complain to the FDA first. This policy is not limited to just medical devices and pharmaceuticals reviewed by the FDA, it also exists for products under the jurisdiction of other Federal agencies, such as consumer products at the US Consumer Product Safety Commission (CPSC) and telecommunications devices reviewed by the US Federal Communications Commission (FCC).Īnd today, victims may only seek review of the devices’ medical “safety and efficacy”. Instead, victims or their families must first bring administrative actions against the manufacturer at the Federal agency level. These manufacturers may not be sued in state courts by individuals claiming injury due to a device failure. The legal principle, Federal Pre-emption of Liability applies to protect device manufacturers whose products have received FDA review and approval. They fall into a category of products originated in the FDA’s pharmaceutical program, but now widely extended by court rulings both within the FDA to connected medical devices.

Most Internet-connected medical devices are subject to FDA review. The concern, a procedural one, involves the inability of injured patients to sue “connected” medical device manufacturers in their state courts for injuries or death due to claims of device failure of US Food and Drug Administration (FDA)-approved medical therapeutic technologies. However, one area of real concern today is entirely within the scope of remediation in the near term, suggesting other possible connected medical device (CMD) improvements. And some of these risks may be beyond the scope of present legal and policy structures to address. WiFi monitoring and adjustments for pacemakers, insulin pumps, home wired diagnostic devices for glucose testing and a host of sensor-delivery tools for therapies offer unprecedented accuracy, immediacy of therapeutic adjustment and associated improvements in survivability and overall quality of life.īut with these innovative applications comes increased risks. Today, the individualization and wearability of diagnostic and therapeutic ICT-enabled devices have only enhanced the physician and patient appetites for these tools.

And it spawned even more imaginative approaches to linking patients to active medical professional care, spanning gaps of distance and time. Tele-diagnosis on site at the airport permits immediate treatment and reduces mortality. In the MGH-Logan pilot, the effort was to reduce mortality among acutely ill passengers by eliminating the “golden Hour” of ER risk in ill or injured passengers by avoiding the notorious rush hour transit time from Logan to MGH. When Massachusetts General Hospital (MGH) inaugurated its experimental remote telemedicine center at Boston’s Logan Airport under a US Departments of Commerce and Health and Human Services joint grant in 1975, it was ushering in a new era of the application of Information & Communications Technology (ICT) to medical challenges. Legal, Regulatory and Policy Challenges at the Bleeding Edge of Mobile Medicine

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