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Preview: Medical Connectivity

Medical Connectivity

Last Build Date: Fri, 23 Sep 2016 21:15:45 +0000


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 […]

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 […]

From Pilot to Policy: Lessons from e-Health Deployed at Scale

Thu, 26 May 2016 16:39:00 +0000

As mentioned in previous posts, the United4Health project was intended to test the deployment at scale of mobile health solutions and to integrate those telehealth services as part of the standard of care. Participants took this to heart and used the project to help tackle larger issues of policy, funding, technology, resources and overall workflow. The […]

Case Study: Sensor Selection for Remote Monitoring

Tue, 10 May 2016 19:08:45 +0000

In a previous blog post, I highlighted general principles for implementing and scaling systems to support remote monitoring of chronic conditions, namely congestive heart failure (CHF), Diabetes Mellitus (Type II Diabetes) and chronic obstructive pulmonary disease (COPD).  In this blog post I will focus on COPD as a case study for the development, implementation and […]

Methods to Access Alarm Data for Analysis

Wed, 30 Mar 2016 18:37:28 +0000

Difficulty getting access to alarm data is the elephant in the living room in the house of alarm fatigue. There are lots of conference presentations, webinars and papers about analyzing medical device alarm data. What’s missing are detailed discussions on how to get to the actual alarm data in the first place. This post will present a […]