Blog Profile / Medical Connectivity

Filed Under:Medical / Healthcare IT
Posts on Regator:91
Posts / Week:0.3
Archived Since:April 6, 2010

Blog Post Archive

FHIR in Action – How Well Does It Work?

 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

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

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

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

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 […]

Major EU Remote Monitoring Pilot Results

This post looks at some lessons learned from remote monitoring projects in Europe.  This and subsequent posts are based on my last eight years of supporting these projects combined with some thoughts from my implementation experience of technology systems in many different scenarios over the last thirty years.   I hope that some of it will be […]

HIMSS16 Recap

It was great to see so many blog readers and old friends at HIMSS this year. For those who downloaded my list of connected health exhibitors, how did the list work for you? I found sorting by booth number really cut down on running back and forth across the show floor. The exhibits are always […]

4 Ways Health Care Is Different

As a $1.7 trillion market with $3.24 trillion in health care expenditures in 2015, the US health care market can be a pretty tempting target to companies, entrepreneurs and investors outside of health care. There’s a lot of opportunity...Show More Summary

HIMSS16 Preview

It’s back to Las Vegas for HIMSS16 in a bit more than a week, which begs the question, what’s going to be theme of this year’s show? There’s typically very little data to apply to questions like that, until now. Drew Ivan, Healthcare Solutions Strategist with Orion Health, wrote a post on LinkedIn on HIMSS16 trends […]

Connectivity and Hackability

It is somewhat ironic that Hospira and Cerner announced a new collaboration on Hospira’s infusion pumps and Cerner’s EHR given that Hospira has recently had more than its share of attention with respect to asserted LifeCare and Symbiq pump cybersecurity vulnerabilities. This attention included a notice from the Department of Homeland Security as well as from the FDA […]

Some Funky Cybersecurity Math

Assessing the magnitude and significance of cyber threats has at least two important purposes. One is to determine the extent of measures that have been or should be taken to respond to or counter the threat. This is part of the rational deployment of resources across the multiple risks that we face, whether cyber or […]

Challenges Using Patient Generated Data for Patient Care

When I do presentations on the use of standards, I invariably have a slide which defines interoperability as “the ability of a system or a product to work with other systems or products without special effort on the part of the customer.” My second slide then defines syntactic and semantic interoperability. Syntactic interoperability occurs when […]

Interview with Sailesh Chutani, CEO, Mobisante

My first exposure to Mobisante and their disruptive diagnostic ultrasound system was the mHealth Summit in November of 2010. At that time, the consumerization of medical devices had been gaining traction, mostly in the physician office market. Show More Summary

The FDA October Workshop on Cybersecurity

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 […]

DHHS OIG Work Plan Targets Networked Devices

The Office of the Inspector General (OIG) of the U.S Department of Health and Human Services has released a report (pdf) outlining its 2015 work plan. Among a host of subjects is “Information Technology Security, Protected Health Information, and Data Accuracy” with the subsection “Controls over networked medical devices at hospitals”. The focus here is […]

FDA Takes Step Backwards with New MDDS Guidance

This summer, FDA proposed lifting regulations from certain currently regulated medical devices. This unprecedented policy shift targets devices known as Medical Device Data Systems (MDDS) and is intended to benefit the mobile app industry and companies like Google, Apple and others. The current regulatory burden for MDDS devices is Class I, 510(k) exempt. This means […]

4 Models for Alarm Vigilance

The method of arranging medical devices and those that recognize and respond to alarms is fundamental to alarm safety. The following are the 4 models or methods for alarm vigilance and notification in use today. These models are: line of sight,out of sight, monitoring techs, and automated notification. Let’s look at each one in turn. […]

Monitoring for Deteriorating Conditions

Monitoring patients at risk of a deteriorating clinical condition (DCC) is a growing patient monitoring need in almost every hospital. Here’s why…  For many years, the need to monitor patients outside traditional high acuity units has been a growing requirement in hospitals. Signs of this growing need have been evident in a number of areas: […]

FDA Issues Draft Guidance on Cybersecurity

The FDA sets manufacturer’s expectations on what is expected to address data security threats in medical devices. This draft guidance (pdf download) applies to conventional embedded system medical devices with embedded software (firmware or programmable logic) and software products regulated as medical devices. Think about that for a few seconds and let the scope of […]

Connectivity and Hackability

It is somewhat ironic that Hospira and Cerner announced […]

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