Patient Management Workflow
A key feature of all connectivity solutions is a database that includes all of the patients associated with the system’s medical devices. This is called a “patient census” or ADT (admission, transfer and discharge), much like the way a hospital’s ADT system manages patient demographics for the hospital information system or EMR. Also referred to as patient management data, these data often include: patient name and ID number (permanent medical record number, episode of care number, or both), current assigned location of the patient, and the device associated with the patient. Depending on the applic...
Source: Medical Connectivity Consulting - November 4, 2013 Category: Technology Consultants Authors: Tim Gee Tags: connectivity Product Development Source Type: blogs
Connectivity Workflows
The objective of this list is to capture all of the basic workflows that apply to multiple types of medical devices. The last two as categories are intended to contain the more highly specialized workflows. Let me know how you might revise this list. (Source: Medical Connectivity Consulting)
Source: Medical Connectivity Consulting - October 28, 2013 Category: Technology Consultants Authors: Tim Gee Tags: connectivity Product Development Source Type: blogs
Mapping Product Transformations Resulting from Connectivity
The above title is the topic for my presentation at this year’s Medical Device Connectivity Conference. The event this year will be held at the Hyatt Dulles in Herndon, VA November 21-22. The agenda is just about finalized; you can check it out here.
This post is both a preview and a bit of thinking out loud as I continue to develop the the presentation. Suggestions or criticisms are welcome via comments below.
Whenever connectivity is added to a product or solution, things change. If this is a new product direction for the company (or a new variation of an established product category purchased by a provider organiz...
Source: Medical Connectivity Consulting - October 21, 2013 Category: Technology Consultants Authors: Tim Gee Tags: Business Planning Product Development Source Type: blogs
Crossing the Chasm with Connectivity
Creating and launching innovative ground-breaking new technologies and solutions is a heady experience, especially in health care where innovations can literally save lives. Pioneering new technology is hard and very expensive work. There is always a rush to get the product finished enough to be able to launch and start generating some revenue. Features considered not essential are pushed farther out on the product roadmap and these products are launched based on the innovations that have been implemented.
A couple of products come to mind as examples: FlowSense Medical’s digital urine flow meter (recently acquired b...
Source: Medical Connectivity Consulting - October 14, 2013 Category: Technology Consultants Authors: Tim Gee Tags: connectivity Product Development Source Type: blogs
Wireless Sensor Design Challenges: Gateways
Wireless sensors are intended to operate via short range wireless communications. That’s why they’re called “body area” networks. Due to power consumption constraints, wireless sensor radios typically don’t operate as 802.11 a/b/g/n radios used in enterprise networks. The reference designs from the manufacturers of radios intended for wireless sensors often indicate a range of a few meters and show wireless sensors communicating with a gateway device that aggregates sensor data and then communicates with the enterprise network where the sensor software applications reside.
When asked if they&#...
Source: Medical Connectivity Consulting - October 7, 2013 Category: Technology Consultants Authors: Tim Gee Tags: Wireless Medical Devices Source Type: blogs
FDASIA Report on Regulating HIT
On September 4, 2013, the FDASIA mandated workgroup presented their recommendations to the Health IT Policy Committee in Washington, D.C. Some reporting on the meeting cast the draft report as downplaying potential FDA regulation of healthcare IT applications (HIT), while others emphasized the uncertainty (subscription required) of the process and ultimate outcome. Such news stories are, by necessity, short and can’t cover all the issues but this one from iHealthBeat provides a good summary.
The final report (links to all draft documents) was submitted September 4, 2013 and was basically unchanged from the preliminar...
Source: Medical Connectivity Consulting - September 30, 2013 Category: Technology Consultants Authors: Tim Gee Tags: Healthcare IT Standards & Regulatory Source Type: blogs
FDA Issues Final Guidance on Mobile Medical Apps
A bit more than two years after releasing their draft guidance, FDA has released the final guidance (pdf) on mobile medical apps (FDA press release). FDA also put up a new page on their web site with information on mobile medical apps.
In this final guidance, FDA has chosen to use two factors to distinguish between mobile medical apps that are low risk that they do not intend to regulate, and higher risk apps that will be regulated. FDA will regulate those mobile medical apps intended:
to be used as an accessory to a regulated medical device; or
to transform a mobile platform into a regulated medical device.
As always wi...
Source: Medical Connectivity Consulting - September 23, 2013 Category: Technology Consultants Authors: Tim Gee Tags: Standards & Regulatory Source Type: blogs
FDA Updates List of Recognized Standards, Confusion Ensues
On August 6, 2013, FDA published modifications to the list of medical device related standards they recognize. News was made of the fact that additions to the recognized standards addressed areas such as cybersecurity and interoperability. While there were many revisions and some additions of a variety of standards, this blog post will focus on the news making standards related to medical device connectivity.
The published modifications are divided between two separate recognition lists, number 31 (pdf) and 32 (pdf). Here is the Federal Register version (PDF). Recognition list number 31 includes one standard under the Soft...
Source: Medical Connectivity Consulting - September 3, 2013 Category: Technology Consultants Authors: Tim Gee Tags: Standards & Regulatory Source Type: blogs
FDA Issues Final Guidance on Wireless Medical Devices
The objective of all this, of course, are wireless medical devices that are safe and effective – when that is the case, receiving FDA premarket clearance is often relatively quick and painless.
Risk Management Issues
The opening sentence in section 3 establishes a key concept for the entire guidance:
Designers and manufacturers of wireless medical devices should consider the ability of their devices to function properly in the intended use environments where other RF wireless technologies will likely be located. [Emphasis added.]
The intended use environment means that FDA expects that your risk analysis and mitiga...
Source: Medical Connectivity Consulting - August 27, 2013 Category: Technology Consultants Authors: Tim Gee Tags: Product Development Standards & Regulatory Wireless Medical Devices Source Type: blogs
Review: EHR, A Systems Analysis of the Medications Domain
A while back I was provided with a review copy of the book, Electronic Health Record: A Systems Analysis of the Medication Domain, by Alexander Scarlat, MD. This book is intended to serve as a practical book about electronic health/medical records systems as used in acute care settings. (For the purposes of this review, the term EHR is intended to refer to both EHRs and EMRs.)
There are two audiences for the book. The first group includes clinicians with little or no expertise in information technology. There are plenty of books for clinicians that provide an introduction into the common capabilities of an EHR. ScarlatR...
Source: Medical Connectivity Consulting - August 2, 2013 Category: Technology Consultants Authors: Tim Gee Tags: Healthcare IT Patient Flow Source Type: blogs
Medical Mobile App Draft Guidance Reaches 2nd Birthday
On July 21, 2011 the FDA released its “Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Application.” We have discussed this draft and mobile apps generally here, here, and here. As with all draft guidance documents, following the release of the draft the FDA is supposed to receive and review comments (reported to be about 130), and then issue a revised draft, a final guidance document, withdraw the draft, or do none of these for an extended period, just letting the draft sit. The latter appears to be the fate of many drafts. The two years that this draft has been out ...
Source: Medical Connectivity Consulting - July 15, 2013 Category: Technology Consultants Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
FDA Offers (draft) Guidance on Cyber Security
The FDA has issued a draft guidance document on the expected content of premarket submissions with respect to medical device cybersecurity. This guidance targets individual medical devices rather than the network they may be resident on, and it also includes non-networked devices. The FDA notes that both networking capability and portable media increase vulnerability. The latter issue might be called intermittent or remote connectivity.
Guidance documents tell interested people what the FDA’s current thinking is relevant to its regulatory authority, in this case the review of 510(k), PMA and related submissions...
Source: Medical Connectivity Consulting - June 14, 2013 Category: Technology Consultants Authors: William Hyman Tags: connectivity Standards & Regulatory Wireless Medical Devices Source Type: blogs
HIT Vendor Seeking MDDS for Meaningful Relationship
As noted before, from time to time I answer questions and exchange ideas with folks from hospitals, companies and with students. It’s a karma thing with me – if I can help out with reasonable effort in situations where there’s no immediate consulting opportunity (although there may in the future), and it’s interesting, then I do what I can.
The following is the most recent exchange from a conversation I’ve been having with a product manager at a HIT software vendor about MDDS. They develop and sell an information system, part of which consumes medical device data. Not every customer already ha...
Source: Medical Connectivity Consulting - May 25, 2013 Category: Technology Consultants Authors: Tim Gee Tags: Business Planning connectivity Healthcare IT Product Development Source Type: blogs
Clinical Workflow & Technology Integration Summit
On June 7th, 2013 the Texas Children’s Hospital and Smith Seckman Reid are producing an educational workshop on medical device connectivity. Nursing is the predominate perspective explored in this event. (One of my pet peeves is all the focus physicians get from vendor’s marketing departments. Yet, when it comes to systems in hospitals, the predominate user – by far – is nursing.)
TCH, an early adopter of clinical documentation into EMRs and alarm notification, has some of the most extensive experience with medical device connectivity in the US. They’re hosting and presenting at this one day s...
Source: Medical Connectivity Consulting - May 20, 2013 Category: Technology Consultants Authors: Tim Gee Tags: Events Source Type: blogs
Enterprise-Wide Medical Device Integration and CIS Workflow
Last month I spoke at the first CIS Qatar International Conference in Doha Qatar. My topic was the Importance of Enterprise Wide Medical Device Integration in CIS workflow. You can download a copy of my presentation here.
This was the first such conference in Qatar with over 1,500 people attending. The ballroom only had capacity for 1,200 so they had remote screens and audio for the 300 overflow attendees. Several hospitals in Qatar are in the process of implementing Cerner’s EMR, so there is a lot of keen interest in all things EMR.
The conference program was focused on implementation issues and what it takes to rea...
Source: Medical Connectivity Consulting - May 14, 2013 Category: Technology Consultants Authors: Tim Gee Tags: connectivity Events Healthcare IT Source Type: blogs
