10 Changes to the FDA ’ s Pre-Cert Program Model
In June 2018 the FDA released an update to its working model of the Software Pre-Cert Program that addresses 10 areas of comments received as a result of the earlier call for public input. In an usual step, these comment driven changes are clearly identified in the document, rather than leaving it to reader to figure out what is new or different. I will briefly address each of these ten areas.
1. The FDA has reiterated that Pre-Cert can apply to organizations of any size. This isn’t new.
2. The FDA notes that it agrees with the principle that there should be flexibility in the “excellence” appraisals that will be ap...
Source: Medical Connectivity Consulting - June 25, 2018 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Strategy & Planning Source Type: blogs
Continuous Clinical Surveillance: ICU Monitoring Outside the ICU
On Tuesday, June 26, I will interview Brian McAlpine, VP of Strategy and Business Development at Bernoulli Health.
Brian and I will discuss continuous clinical surveillance of patients in units such as med-surg, critical care, step-down and telemetry using real-time medical device data. We will also explore the ways technology-assisted clinical surveillance increases safety, lowers costs and offers timely and accurate clinical decision support to identify patients who are developing problems.
Register Now
Join us for this 1-hour Event and you will learn:
What is continuous clinical surveillance, and how (delete-does) it d...
Source: Medical Connectivity Consulting - June 6, 2018 Category: Information Technology Authors: Tim Gee Tags: Interviews Source Type: blogs
Ranking the Importance of SaMD — Software as a Medical Device (UPDATE)
In the May 10th Pre-Cert webinar the FDA addressed an interesting risk matrix that was previously seen in the Software as a Medical Device (SaMD) guidance document, which we discussed here. While a risk matrix involving severity and probability is familiar to many, the SaMD matrix is different in that it addresses the significance of the state of health of the subject of the software and the importance of the information that the software would provide. There are three levels for health: critical, serious, non-serious. There are also three levels for significance given as Treat or Diagnose, Drive Clinical Management, an...
Source: Medical Connectivity Consulting - May 30, 2018 Category: Information Technology Authors: William Hyman Tags: Healthcare IT Standards & Regulatory Source Type: blogs
Ranking the Importance of SaMD — Software as a Medical Device
In the May 10th Pre-Cert webinar the FDA addressed an interesting risk matrix that was previously seen in the Software as a Medical Device (SaMD) guidance document, which we discussed here. While a risk matrix involving severity and probability is familiar to many, the SaMD matrix is different in that it addresses the significance of the state of health of the subject of the software and the importance of the information that the software would provide. There are three levels for health: critical, serious, non-serious. There are also three levels for significance given as Treat or Diagnose, Drive Clinical Management, an...
Source: Medical Connectivity Consulting - May 30, 2018 Category: Information Technology Authors: William Hyman Tags: Healthcare IT Standards & Regulatory Source Type: blogs
Ranking the Importance of SaMD — Software as a Medical Device
In the May 10th Pre-Cert webinar the FDA addressed an interesting risk matrix that was previously seen in the Software as a Medical Device (SaMD) guidance document, which we discussed here. While a risk matrix involving severity and probability is familiar to many, the SaMD matrix is different in that it addresses the significance of the state of health of the subject of the software and the importance of the information that the software would provide. There are three levels for health: critical, serious, non-serious. There are also three levels for significance given as Treat or Diagnose, Drive Clinical Management, an...
Source: Medical Connectivity Consulting - May 30, 2018 Category: Information Technology Authors: William Hyman Tags: Healthcare IT Standards & Regulatory Source Type: blogs
Joint Commission Allows Texting Orders: Now What?
It's safe to say every hospital has a need to text orders to some degree. Now that the Joint Commission has reversed their position stated in a FAQ page in 2011 and said texting orders is now okay (downloadable pdf), where do we go from here?
There have always been scenarios where caregivers need new or revised orders to address a patient care issue more quickly than the typical frequency of physician rounding and sitting down to interact with the CPOE system. Common use cases include the need to change alarm parameters to better fit the patient and reduce non-actionable alarms, interventional orders in response to a ...
Source: Medical Connectivity Consulting - May 17, 2018 Category: Information Technology Authors: Tim Gee Tags: Messaging & Orchestration Source Type: blogs
Real-Time Situational Awareness Discussion with Dr Ben Kanter
Discussion with Dr Ben Kanter appeared first on Medical Connectivity. (Source: Medical Connectivity Consulting)
Source: Medical Connectivity Consulting - May 14, 2018 Category: Information Technology Authors: Tim Gee Tags: Interviews Messaging & Orchestration Source Type: blogs
Real-Time Situational Awareness Discussion with Dr Ben Kanter
Join me for an in-depth discussion with Ben, Kanter, MD, and CMIO of Vocera Communications.
This 1-hour event will take place on Monday, May 21st, 2018 at 10:00am Pacific, 1pm Eastern.
The topic for this event is situational awareness. We constantly hear how important this is, especially in dynamic environments where things can change rapidly... like in patient care.
What is Situational awareness? It's the thoughtful consideration people give to factors about a situation or task that dictate what information they and others need, when they need it, and how to prioritize competing demands. It is a recognized “non-tech...
Source: Medical Connectivity Consulting - May 14, 2018 Category: Information Technology Authors: Tim Gee Tags: Interviews Messaging & Orchestration Source Type: blogs
Messaging Value Pyramid – A Discussion with Ron Remy
Join Ron Remy and me in a discussion of the value pyramid model (pictured below) as it applies to messaging systems for care teams providing enterprise-wide patient care.
Register Here
Value Pyramid by Ron Remy, CEO, Mobile Heartbeat
Ron and I will discuss:
Requirements for moving up the value pyramid
The shift from point solutions to adopting enterprise-wide communications
How messaging adoption can be leveraged for process and workflow re-engineering and quality improvement
Aligning customer aspirations with their level of achievement on the value pyramid.
During the interview, we will also take questions from those at...
Source: Medical Connectivity Consulting - April 10, 2018 Category: Information Technology Authors: Tim Gee Tags: Interviews Messaging & Orchestration Source Type: blogs
The Inside Story on Wireless in Health Care – A Discussion with David Hoglund
Join me for an in-depth discussion with David Hogland, a long time colleague of mine as we discuss all things wireless in health care.
This 1-hour event will take place on Wednesday, March 28, 2018 at 10:00am Pacific, 1pm Eastern.
Register Here
Our discussion will delve into the following areas:
The differences between consumer and enterprise wireless technologies and how they impact usability
The use of cellular in hospitals
Wireless medical device best practices
The best wireless technologies for health care
Common wireless mistakes by manufacturers and providers
During the interview, we will also take questions from t...
Source: Medical Connectivity Consulting - March 21, 2018 Category: Information Technology Authors: Tim Gee Tags: Interviews Wireless Source Type: blogs
Thoughts on Clinical Decision Support and its Future: Dr Greenes Interview
In two of my last blog posts, I have interviewed people and companies working in the support and implementation of decision support. With this blog post, I have the honor of interviewing Robert A. Greenes, MD, PhD, one of the first and leading researchers in clinical decision support (CDS) and my former CDS professor. He started as a co-developer of MUMPS in the 1960s while at Harvard Medical School and from there has been and continues to be involved in all aspects of CDS. One of his latest works has been editing and writing chapters for the first and second editions of Clinical Decision Support, The Road to Broad Ad...
Source: Medical Connectivity Consulting - March 14, 2018 Category: Information Technology Authors: Bridget Moorman Tags: Clinical Decision Support Source Type: blogs
Will Pre-Cert Increase the Advantage of Big Companies? (UPDATE)
The impact of FDA's digital health Pre-Cert program has yet to be fully seen. 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 under motivated. Small has entrepreneurial zeal and fewer rules. I once heard that zeal turned into advice to job candidates that you shouldn’t express interest in any hobbies during your interview because they didn’t want people with distractions. Small may also have no income, but that is a separate matter. How...
Source: Medical Connectivity Consulting - March 2, 2018 Category: Information Technology Authors: William Hyman Tags: Mobile Health Standards & Regulatory Source Type: blogs
Will Pre-Cert Increase the Advantage of Big Companies?
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 job candidates that you shouldn’t express interest in any hobbies during your interview because they didn’t want people with distractions. Small may also have no income, but that is a separate matter. However, design/product development is only part of the challenge in medical devic...
Source: Medical Connectivity Consulting - March 2, 2018 Category: Information Technology Authors: William Hyman Tags: Mobile Health Standards & Regulatory Source Type: blogs
Health Care Messaging and Orchestration — Systems of Action (UPDATED)
The objective of a RTHS is providing the right information, at the right time, in the right format, to the right user(s). In a RTHS, systems are designed to sense the need for a change in process, operations or strategy. Gartner attributes the following characteristics to a RTHS:
Aware — a RTHS utilizes situational awareness and generates context-sensitive information
Adaptive — a RTHS is more proactive (anticipate and predict) than reactive
Collaborative — a RTHS uses a conversational user interface to engage clinicians, staff and patients within or across healthcare organizations.
Mobile — a RTHS optimizes workf...
Source: Medical Connectivity Consulting - February 12, 2018 Category: Information Technology Authors: Tim Gee Tags: Healthcare IT Messaging & Orchestration Strategy & Planning Emergin Source Type: blogs
Health Care Messaging and Orchestration — Systems of Action
The objective of a RTHS is providing the right information, at the right time, in the right format, to the right user(s). In a RTHS, systems are designed to sense the need for a change in process, operations or strategy. Gartner attributes the following characteristics to a RTHS:
Aware — a RTHS utilizes situational awareness and generates context-sensitive information
Adaptive — a RTHS is more proactive (anticipate and predict) than reactive
Collaborative — a RTHS uses a conversational user interface to engage clinicians, staff and patients within or across healthcare organizations.
Mobile — a RTHS optimizes workf...
Source: Medical Connectivity Consulting - February 12, 2018 Category: Information Technology Authors: Tim Gee Tags: Healthcare IT Messaging & Orchestration Messaging Middleware Strategy & Planning Emergin Source Type: blogs
