1) Accessories to regulated medical devices, and
2) Transformation of a mobile platform into a medical device (e.g. smart phone).
As mentioned in the above link, the FDA reportedly cleared about 100 mobile medical applications over the last 10 years. The link also provides information regarding the FDA-cleared mobile medical applications and guidance for mobile health device makers.
Incidentally, discussion over whether or not to include Electronic Health Records (EHR) as a regulated medical device has been discussed as recently as November 2013 as reported on Health IT Exchange. In an opinion letter to HHS Secretary Kathleen Sebelius, the HIMSS Electronic Health Record (EHR) Association expressed concern that regulation of EHRs “beyond what is currently in place is not appropriate until further analysis of data and the establishment of a risk-based framework have been completed. The association’s letter also stated that such a 'formal, regulatory approach' to health IT is not warranted.”
The current controversy regarding EHRs as medical devices likely originates from unintended consequences, research and testimony to federal committees raising the issue that EHRs may cause errors, as well as increased incidence of adverse events and near misses associated with their use. Given the potential for patient harm, one must consider that EHRs are tools. People use these tools, and the tool does not substitute for professional knowledge and judgment in its use. That said, certification criteria should also ensure proper functioning of applications to prevent problems as the result of improper functioning.
So what's the point? Healthcare tools (EHRs, medical devices, and mobile applications, etc.) used in the delivery of care to patients, absolutely requires knowledge of how to use the tool and the necessary education that could prevent unintended miss-use as well as prevention of errors in the application and device.
Considering the future opportunities for national use of Telemedicine, proper functioning, knowledge and education related to use of the applications and technology are critical.
I know it has been some time since my last post, but I am in the midst of acquiring a Masters in Health Informatics and have not had much "free time." That said, today I was looking through some files and came across this PowerPoint from 2004.
Link: For more information, visit the post about Regina's Dark Willow and 73 Cents
I met Regina Holliday at a healthcare conference last year. Her artistic gift was known long before that time and continues to tell the stories of the infirm and those who are terminally ill. She now engages with a group of artists to continue the stories, the sorrow, memories and the grief of those who have lost a loved one or a friend. I believe art of this nature frees the mind, soothes the spirit, and forever holds the memories we wish to keep.
Healthcare is more than technology, more than software, more than informatics, more than clinical professionals and treatments. Healthcare is about you, me, our neighbors.
Part 2 touches on the hidden costs of Healthcare Information Technology (HIT) and drivers for improving quality of patient care.
The largest investment in Healthcare technology goes beyond installation and to the training and use of these systems. Training is often a hidden cost which impacts perspective on Total Cost of Ownership that may, in fact, be one of the largest costs.
Keep in mind that from a clinical perspective, one of the most important benefits of HIT is to reduce inefficiencies and improve the quality of care. So, there are some costs savings to be realized when the technology is used accurately.
Improving the quality of patient care is a major goal for healthcare, across all disciplines, driven by the National Quality Strategy (among others) for adoption of quality and compliance measures to monitor quality of care. Compliance with these aims can be monitored in the aggregate or at a patient level in most CDS systems.
The National Quality Strategy is driving change in healthcare to improve quality. The 3 aims of the National Quality Strategy are:
Better Care: Improve the overall quality, by making health care more patient-centered, reliable, accessible, and safe.
Healthy People and Communities: Improve the health of the U.S. population by supporting proven interventions to address behavioral, social, and environmental determinants of health in addition to delivering higher-quality care.
Affordable Care: Reduce the cost of quality health care for individuals, families, employers, and government.
But a new twist on the value of Clinical Data available for "mining" and "drilling" are "databases of clinical information" that can be used for medical research.
Given this opportunity, some costs associated with traditional Clinical Trials may be mitigated by using information obtained from an EMR and Clinical Decision Support system (CDS).
Using this technology, data can be massaged and analyzed in a manner that provides retrospective views of medical data for research. These technologies become enablers for Medical Research and Clinical Decision Support Analysis.