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Standards & Regulatory | Medical Connectivity

Last Build Date: Wed, 14 Mar 2018 00:21:37 +0000


Will Pre-Cert Increase the Advantage of Big Companies?

Fri, 02 Mar 2018 20:53:18 +0000

There is much debate about the relative advantages of big vs small companies on the development side of the device/product equation. The classic view is that big has the resources and experience, but perhaps is over constrained and undermotivated. Small has entrepreneurial zeal and fewer rules. I once heard that zeal turned into advice to […]

FDA Busy With Software

Wed, 20 Dec 2017 00:16:16 +0000

Since connectivity runs on software, and some medically related software is a medical device, and medical devices are regulated by the FDA, those involved in connectology must pay at least some attention to what the FDA is saying about the subject of medical software that is not an inherent part of some other medical device.  […]

FDA Guidance on Software Changes

Mon, 13 Nov 2017 23:05:26 +0000

On October 25, 2017 the FDA released its guidance on "Deciding When to Submit a 510(k) for a Software Change to an Existing Device". A draft of this guidance was released in August 2016 and I commented on that draft here. The scope of what was changed is not easy to discern, especially since the draft […]

FDA to Address Cybersecurity at Workshop

Mon, 08 May 2017 17:00:57 +0000

Cybersecurity continues to be a hot topic in healthcare with several areas of concern. These include the theft of personal health information from a provider's database, using ransom wear to extract payment from providers without actually stealing information, and compromising the performance of medical devices that are connected to the network, employ wireless functions or […]

Sussing Out SaMD

Mon, 12 Dec 2016 17:28:56 +0000

Software as a Medical Device (SaMD) is terminology under the aegis of a work group of the International Medical Device Regulators Forum (IMDRF) of which the FDA is a member. SaMD is distinct from software in a medical device although "in" these days may have a looser meaning closer to is a part of.  The notion that […]

Muddy Waters Alleges St Jude’s Devices Vulnerable to Cyberattack

Fri, 02 Sep 2016 18:00:43 +0000

On August 25, 2016, Muddy Waters Research (MWR) published a report titled, MW is Short St Jude Medical, claiming that St Jude Medical's (STJ) connected cardiac rhythm management products should be recalled due to exceptionally poor data security.  MWR claims: The effected products include the Patient Care Network, Merlin@home remote monitoring gateways and implantable pacemakers and ICDs […]

When Does Regulated Software Need a New 510(k)?

Fri, 19 Aug 2016 17:27:20 +0000

A ubiquitous characteristic of software is that it often undergoes numerous changes after it is first released for general use. These changes may be to fix things that were never right in the first place, or to provide new features and/or greater security. If the software is a “medical device”, or part of a medical device, […]

FHIR in Action – How Well Does It Work?

Wed, 22 Jun 2016 16:50:04 +0000

 Two years ago, I was at eHealth week in Athens, Greece, and stumbled upon several other Americans who represented the Office of the National Coordinator (ONC) touting Fast Healthcare Interoperability Resources (FHIR) as a standard that would help move healthcare interoperability forward more quickly than what we have seen over the last few decades. FHIR […]

Advice from the FDA on Medical Device Data Sharing

Mon, 13 Jun 2016 21:59:00 +0000

Among the many forms of data flow that might occur from a medical device is direct to the patient. This received some notoriety when a patient wanted to access the output directly from their own implanted device. They had to do battle with the device manufacturer who claimed among other things that the FDA would […]

The FDA October Workshop on Cybersecurity

Mon, 05 Jan 2015 19:43:06 +0000

If it were possible to be unaware of the general problem  of cybersecurity, the recent Sony hack with its public disclosures of  "private" e- conversations and then terroristic blackmail, following the earlier release of celebrity cloud photos, ought to have provided notice that what is electronically stored is likely to be available to those determined […]