To Hack, or not to Hack, that is the Question

Hacking could improve medical device quality and security, but in the face of jail-time, trying isn’t so appealing.

August 16, 2013

The word “hackers” makes us think of identity thieves and friends posting embarrassing statuses on one another’s Facebook. But the hacking community could also save lives.

Medical device applications have seen their share of shortcomings, and hackers can expose flaws more easily than you’d expect. Computer World’s "FDA asks hackers to expose holes in medical devices, but many researchers fear CFAA & jail" explores the turmoil of those trying to help in an unconventional way.

Medical apps may be running wild, but not if the FDA has its way.

August 06, 2013

With growing concerns over patient safety, app effectiveness, and compliance to other laws, notably HIPAA, the FDA is stepping in. The Verge’s "Side effects may vary: the growing problem of unregulated medical apps” poses the question, “Can the FDA crack down on phony medical apps without killing innovation?”

MTC created a tracking and workflow application for Boston Scientific to comply with state and Federal legislative requirements

January 14, 2013

To comply with Sunshine Act requirements, MTC created a web-based system for Boston Scientific to manage the entire reporting and payment process to physicians for speaking engagements, lunches, proctorships and preceptorships.

The Sunshine Act states that any drug, device, or medical supply manufacturer operating in the United States must report any payment or benefit given to a physician. It changes significantly how drug companies and CROs think about payments to medical professionals. Payments under $10 are excluded, but only if the total spent on that HCP is less than $100 annually.

Companies will need to begin recording this information in early 2013.