July 2019 SaMD PreCert Update
We have been following the FDA's Software as Medical Device (SaMD) Pre-Cert pilot. The premise of the pilot is that a quality software development process, which has been certified by the FDA, can provide a reasonable assurance of safety and efficacy for low and medium risks SaMD without it being necessary to examine the product itself as in the more traditional pathway. There is supposed to be value in doing this quality approach, i.e., it's not just different but better.
In the latest update FDA has highlighted some progress and ongoing activity. In one exercise the FDA has retrospectively applied its excellence appra...
Source: Medical Connectivity Consulting - July 25, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
Are We Over Connected Yet?
Some of us remember when distributed medical devices such as patient monitors had their own dedicated server. That server had one job, to support that manufacturer's medical devices. It was not connected to the enterprise network, in part because there was no network. It did not utilize wireless communication, although there were instances it which it might be susceptible to rogue wireless input. Even the manufacturer could not talk to it remotely. Other functions were not supported by this server. For example, the hospital’s vending machines were on their own.
Only a limited number of people had physical access th...
Source: Medical Connectivity Consulting - July 9, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
Disrupting Nurse Call
Change is disrupting nurse call. After decades of slow incremental change, the pace of change is quickening. These changes impact provider organizations and manufacturers as nurse call is integrated with adjacent market point of care solutions and new technologies. The benefits will be substantial: improved HCAHPS scores, improved patient safety, shorter length of stay and greater staff productivity. Lagging providers and manufacturers will miss out on the benefits of these new capabilities. Let's look at the recent past of the nurse call market and where we might be going in 2019 and beyond.
In this post we'll look at ...
Source: Medical Connectivity Consulting - June 7, 2019 Category: Information Technology Authors: Tim Gee Tags: Nurse Call Strategy & Planning Source Type: blogs
FDA Seeks SaMD PreCert Mock Applicants
FDA has issued a request for SaMD developers to try out the PreCert excellence appraisal process. Since this is a test program the FDA does not intend to actually provide precertification for participating companies. Criteria for those choosing to participate include:
Have a plan to submit a De Novo Request or 510(k) submission for a SaMD product prior to June 2020. Be in good standing with the FDA. Agree to follow aspects of the FDA's working model including providing access to certain key performance indicators, collecting real-world postmarket performance data and make it available to the FDA, be available for real-t...
Source: Medical Connectivity Consulting - June 3, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
Capsule Tech Acquires Bernoulli Health: Analysis
On April 30, 2019, Capsule Tech announced that it is acquiring Bernoulli Health for an undisclosed amount. This acquisition combines two market leaders in the medical IoT, IoMT, biomedical medical device integration (BMDI), medical device data system (MDDS), medical device connectivity, or whatever you call this market.
Medical devices are by far the greatest source of data in health care. For many years the vast majority of medical device data simply scrolled off the screen, never reaching clinicians for analysis and alerting. Capturing this data and using it to better diagnose, treat and monitor patients is finally t...
Source: Medical Connectivity Consulting - May 8, 2019 Category: Information Technology Authors: Tim Gee Tags: Clinical Alarms Clinical Decision Support Company Profiles Connectivity Remote Monitoring Strategy & Planning Surveillance Monitoring Source Type: blogs
Healthcare Messaging & Orchestration — 2019
The objective is to provide a solution that can span tens or hundreds of hospitals in a system, enabling intra-enterprise messaging on a large scale and aggregating data at the enterprise level. Mobile Heartbeat and Spok are moving in this direction.
A different but related capability to enterprise scalability is inter-enterprise communications. There is a significant amount of communications between those within a provider organization and external health care trading partners that also care for the patient. These different users include hospital clinicians/caregivers, physician practices, sub acute care, patients, an...
Source: Medical Connectivity Consulting - April 15, 2019 Category: Information Technology Authors: Tim Gee Tags: Company Profiles Messaging & Orchestration Source Type: blogs
Healthcare Messaging & Orchestration — 2019
The objective is to provide a solution that can span tens or hundreds of hospitals in a system, enabling intra-enterprise messaging on a large scale and aggregating data at the enterprise level. Mobile Heartbeat and Spok are moving in this direction.
A different but related capability to enterprise scalability is inter-enterprise communications. There is a significant amount of communications between those within a provider organization and external health care trading partners that also care for the patient. These different users include hospital clinicians/caregivers, physician practices, sub acute care, patients, an...
Source: Medical Connectivity Consulting - April 15, 2019 Category: Information Technology Authors: Tim Gee Tags: Company Profiles Messaging & Orchestration Source Type: blogs
Healthcare Messaging & Orchestration — 2019
The objective is to provide a solution that can span tens or hundreds of hospitals in a system, enabling intra-enterprise messaging on a large scale and aggregating data at the enterprise level. Mobile Heartbeat and Spok are moving in this direction.
A different but related capability to enterprise scalability is inter-enterprise communications. There is a significant amount of communications between those within a provider organization and external health care trading partners that also care for the patient. These different users include hospital clinicians/caregivers, physician practices, sub acute care, patients, an...
Source: Medical Connectivity Consulting - April 15, 2019 Category: Information Technology Authors: Tim Gee Tags: Company Profiles Messaging & Orchestration Source Type: blogs
FDA on Modifying AI
Recently the FDA released a discussion paper on a Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).
For starters this paper captures several familiar themes. One is that standalone software can be a medical device (SaMD) and therefore subject to FDA regulation. In the Clinical Decision Support space of standalone software this captures systems that are built by machine learning (ML), as opposed to systems that are rule-based, or more algorithmic. One way to appreciate this distinction is that for algorithmic systems the user ca...
Source: Medical Connectivity Consulting - April 9, 2019 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
