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Medical Connectivity





Last Build Date: Tue, 21 Mar 2017 22:00:54 +0000

 



Eight Questions Every Prospect Needs Answered Before They Buy

Tue, 21 Mar 2017 21:59:25 +0000

When making a considered purchase, like most high tech products in health care, buyers have to feel comfortable about making the purchase decision. These prospects need to know certain things to feel comfortable making a commitment to you and your product. In mature replacement markets, buyers already know the answers to all or most of […]



DocBox Introduces New Open Clinical Decision Support Platform

Thu, 09 Feb 2017 00:06:33 +0000

While reading a couple of articles in the healthcare IT industry, several statements stood out as they highlighted some of the issues with EHRs, the data they collect, and how useful that data is to clinicians.  In a recent Healthcare IT news article Dr Anders of Medicomp stated with regard to his desire to follow […]



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 Merlin.net Patient Care Network, Merlin@home remote monitoring gateways and implantable pacemakers and ICDs […]



How to Eliminate Innovation Obstacles

Thu, 25 Aug 2016 17:11:09 +0000

Innovation — whether in business, technology or health care delivery — is about figuring out how to do something in a new and better way. To succeed we must overcome challenges and obstacles, and one of the most common challenges is the unknown. Fortunately there are methods and tools for gaining most of the knowledge necessary […]



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, […]



The Best Way to Prepare to Text Physician Orders

Mon, 25 Jul 2016 23:21:30 +0000

How We Got Here Back in May 2016, the Joint Commission (JC) issued an update in their Perspectives publication describing their new position on allowing the secure texting of physician orders. (You can download a PDF of the update here.) This update reversed a position the JC laid out in 2011, “…stating that it is not acceptable […]



How to Ensure Operational Support Keeps Up with Product Innovation

Tue, 05 Jul 2016 20:06:06 +0000

The business delivery system (BDS) for a company includes all of the operational resources, services, policies and procedures used by the company to generate sales, and successfully install, service and support the company’s systems. Every company’s business delivery system is optimized to support the requirements arising from the features and technologies in their products. Innovations […]



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 […]