New Conference on Health Care Messaging
Planning has begun for the inaugural Health Care Messaging Conference. A search is underway for a venue, and once that is secured, the dates for the conference will be finalized. Produced by Satish Kavirajan of The Center for Business Innovation, the conference will occur some time around October or November of this year (2017). To my knowledge, this will be the first ever vendor-neutral conference on health care messaging.
As program chair, I am actively seeking nominations for speakers and presentation topics. If you’ve got suggestions and are inclined to share them, email or Skype me. I’ve been talking...
Source: Medical Connectivity Consulting - June 6, 2017 Category: Information Technology Authors: Tim Gee Tags: Events Messaging Middleware Source Type: blogs
Health Care Messaging Use Cases
Conclusion
A detailed understanding of the buyer’s workflow is perhaps the most important aspect of selecting the best health care messaging solution, regardless of the use case(s) being automated. This post provides some insight into the use cases that current messaging vendors consider important enough (or popular with buyers?) to actively promote. Website descriptions and demos of use cases will always look impressive, but it is only through a detailed comparison with your own institution’s workflow that the solution that is the best fit can be discovered.
Suggestions for additional use cases are most welcom...
Source: Medical Connectivity Consulting - May 26, 2017 Category: Information Technology Authors: Tim Gee Tags: Messaging Middleware care management Emergin patient engagement secure text messaging secure-messaging Source Type: blogs
FDA to Address Cybersecurity at Workshop
Cybersecurity continues to be a hot topic in healthcare with several areas of concern. These include the theft of personal health information from a provider’s database, using ransom wear to extract payment from providers without actually stealing information, and compromising the performance of medical devices that are connected to the network, employ wireless functions or are otherwise hackable in either real or imagined scenarios. One might note that these latter concerns may not be in proportion to the actual risk, ie they attract a great deal of attention and gnashing of teeth but in a rationale hierarchy of act...
Source: Medical Connectivity Consulting - May 8, 2017 Category: Information Technology Authors: William Hyman Tags: Data Security Standards & Regulatory Source Type: blogs
Eight Questions Every Prospect Needs Answered Before They Buy
When making a considered purchase, like most high tech products in health care, buyers have to feel comfortable about making the purchase decision. These prospects need to know certain things to feel comfortable making a commitment to you and your product.
In mature replacement markets, buyers already know the answers to all or most of these questions because they’ve bought these kinds of products many times before. Selling into emerging or disrupted markets is harder because buyers have little or no experience buying those specific products. Thus, they often don’t know all the questions, and they certainly don’t...
Source: Medical Connectivity Consulting - March 21, 2017 Category: Information Technology Authors: Tim Gee Tags: Go to Market Source Type: blogs
DocBox Introduces New Open Clinical Decision Support Platform
While reading a couple of articles in the healthcare IT industry, several statements stood out as they highlighted some of the issues with EHRs, the data they collect, and how useful that data is to clinicians. In a recent Healthcare IT news article Dr Anders of Medicomp stated with regard to his desire to follow a diabetic patient that, “I have to click on six different places to see if the patient’s renal condition is getting better or worse.” In another article, InterMountain announced that they were working with Clinical Architecture to develop a “clinigraphic technology, which leverages ontolog...
Source: Medical Connectivity Consulting - February 9, 2017 Category: Information Technology Authors: Bridget Moorman Tags: Clinical Decision Support Connectivity Source Type: blogs
Sussing Out SaMD
Software as a Medical Device (SaMD) is terminology under the aegis of a work group of the International Medical Device Regulators Forum (IMDRF) of which the FDA is a member. SaMD is distinct from software in a medical device although “in” these days may have a looser meaning closer to is a part of.
The notion that “stand alone” software, operating on a general purpose computer could be or is a medical device was at one time debated by some but this has been resolved by various regulatory bodies who declared that the discussion was now over and that software is a medical device if it meets the de...
Source: Medical Connectivity Consulting - December 12, 2016 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
Muddy Waters Alleges St Jude ’ s Devices Vulnerable to Cyberattack
In this report, MWR suggests STJ has been negligent in not addressing blatant data security vulnerabilities.
MedSec was founded 18 months ago by a team of researchers in Miami. They immediately undertook an effort to research a set of medical device systems, including the STJ system.
In an interview, MedSec CEO, Justine Bone described the following rationale for the decision to disclose:
MedSec researchers found that the STJ products were exceptionally lax in their data security when compared to the other manufacturer’s products they investigated over the past 18 months (see the supporting table comparing STJ to 3 o...
Source: Medical Connectivity Consulting - September 2, 2016 Category: Information Technology Authors: Tim Gee Tags: Data Security Remote Monitoring Standards & Regulatory Source Type: blogs
How to Eliminate Innovation Obstacles
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 to innovate; we will discuss some of them in this post.
Into the Unknown
By definition, when you’re innovating, you’re doing something that hasn’t been done before — if not ever, at least by your organization. These things for which you and your organization lack experienc...
Source: Medical Connectivity Consulting - August 25, 2016 Category: Information Technology Authors: Tim Gee Tags: Connectivity Patient Safety Product Development Strategy & Planning Source Type: blogs
When Does Regulated Software Need a New 510(k)?
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, or connects medical devices, then changes may come under the FDA’s regulatory processes.
New Draft Guidance from FDA
A recurring question for software that is a medical device and which is actively regulated is when do changes to that software require a new 510(k) if Class II or a new PMA or P...
Source: Medical Connectivity Consulting - August 19, 2016 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
The Best Way to Prepare to Text Physician Orders
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 for physicians […] to text orders for patient care, treatment, or services to the hospital or other health care settings.” The May 2016 update stated, “…effective immediately, the JC has revised its position on the transmission of orders for care, treatment and...
Source: Medical Connectivity Consulting - July 25, 2016 Category: Information Technology Authors: Tim Gee Tags: Messaging Middleware Mobile Health Secure Messaging Source Type: blogs
How to Ensure Operational Support Keeps Up with Product Innovation
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 like new connectivity features often have a substantial impact on a company’s BDS. In most situations, product features and technologies change gradually over time and require little focus on BDS optimization. New and innovative...
Source: Medical Connectivity Consulting - July 5, 2016 Category: Information Technology Authors: Tim Gee Tags: Connectivity Strategy & Planning Source Type: blogs
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 has been developed by the HL7 standards organization and among some of its features is based upon RESTful techniques and the Pareto idea of addressing 80% of the most common clinical use cases. At that time (2014), I started a dialogue with some of the writers of the stan...
Source: Medical Connectivity Consulting - June 22, 2016 Category: Information Technology Authors: Bridget Moorman Tags: Healthcare IT Standards & Regulatory Source Type: blogs
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 not allow them to make the data available. It turns out that the “FDA won’t let us” is a well known, if not necessarily correct, excuse in a different arena, that of medical device service and repair.
The FDA has added some clarification in this area with a recent Draft Guidance Document (DGD) en...
Source: Medical Connectivity Consulting - June 13, 2016 Category: Information Technology Authors: William Hyman Tags: Standards & Regulatory Source Type: blogs
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 following interview explores some of these larger issues, specifically: the need to realign payment models, challenges around the adoption of communications and data standards, the role of test and certification bodies like Continua, overcoming systems integration challe...
Source: Medical Connectivity Consulting - May 26, 2016 Category: Information Technology Authors: Bridget Moorman Tags: Mobile Health Source Type: blogs
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 scaling of a remote monitoring system.
Definition of COPD
The World Health Organization (WHO) defines COPD as a “…lung disease characterized by chronic obstruction of lung airflow that interferes with normal breathing and is not fully reversible [̷...
Source: Medical Connectivity Consulting - May 10, 2016 Category: Information Technology Authors: Bridget Moorman Tags: Mobile Health Source Type: blogs
