healthcare technology

Cybersecurity attacks on Healthcare and Public Health (HPH) critical infrastructure, such as healthcare delivery organizations (HDOs), are occurring with greater frequency.  Disruptions in clinical care operations can put patients at risk.

Securing critical infrastucture is a shared responsibility across many stakeholders, and with respect to medical
devices the primary stakeholders are FDA, Medical Device Manufacturers (MDMs), and HDOs.

A common preparedness and response challenge FDA heard from its stakeholders in the aftermath of the aforementioned attacks is that

• HDOs did not know with whom to communicate (e.g. MDM-HDO interactions);
• what actions they might consider taking;
• and what resources were available to aid in their response.

Without timely, accurate information and incorporation of medical device cybersecurity into their organizational emergency response plans, it was difficult for HDOs to assess and mitigate the impact of these attacks on their medical devices.

To address this unmet need, the MITRE team (with the support of FDA), engaged with a broad distribution of stakeholder groups to understand the gaps, challenges, and resources for HDOs participating in medical device cybersecurity preparedness and response activities.

Their efforts resulted in the creation of this playbook that may serve as a resource for HDOs.

The playbook provides a stakeholder-derived, open source, and customizable framework that HDOs may choose to leverage as a part of their emergency response plans in order to ultimately limit disruptions in continuity of clinical care as well as the potential for direct patient harm stemming from medical device cyber security incidents.

The link to the PDF of the first version of the playbook -> https://www.mitre.org/sites/default/files/publications/pr-18-1550-Medical-Device-Cybersecurity-Playbook.pdf

Improved and standardized reporting across healthcare organizations is needed to better understand the impact of health information technology (IT) on adverse events, according to a report from the Office of the National Coordinator for Health IT (ONC).  

The Health Information Technology Adverse Event Reporting: Analysis of Two Databases studied the Common Formats used to encourage adverse event reporting in 2 Patient Safety Organizations: UHC and ECRI Institute.   After analyzing hundreds of thousands of adverse events from all causes reported from since January 2011 for UHC and October 2009 for ECRI, ONC found there are definite areas of improvement.  

“Healthcare organizations and health IT developers, working with PSOs, can use evidence like this to focus their efforts to use health IT to make care safer and to continuously improve the safety of health IT,” Kathy Kenyon, JD, senior policy analyst for ONC, wrote in a blog post.  

For instance, in the ECRI database, the Yes/No question on health IT involvement was answered only 4% of the time. UHC did better, although the question was still only answered roughly half of the time.  

An analysis of UHC’s database found the most common contributing factors to health IT-related events were communication among staff and team members (40%-42%), staff inattention (33%-34%), and accuracy of the data (21%-23%). Furthermore, a third of health IT-related events were medication-related, making them the most common type.  

However, despite the usefulness of UHC’s database, more than half of the health IT-related events were categorized as “other,” which makes it difficult to determine the clinical problem involved in these events, according to Ms Kenyon. -

See more at: http://www.ajmc.com/newsroom/Health-IT-Related-Adverse-Event-Reporting-Needs-Improvement#sthash.tEhiA8At.dpuf

The Food and Drug Administration (FDA), which regulates everything from heart monitors to horse vaccines, will soon have its hands full with consumer health apps and devices.

The vast majority of the health apps you’ll find in Apple’s or Google’s app stores are harmless, like step counters and heart beat monitors. They’re non-clinical, non-actionable, and informational or motivational in nature.

But the next wave of biometric devices and apps might go further, measuring things like real-time blood pressure, blood glucose, and oxygen levels.

Personalized medicine, or the ability for the medical profession to tailor therapy to particular individuals’ genetic characteristics, has been a long desired but ever elusive goal for the life sciences.  However, the prospects for personalized medicine appear to be improving in recent years.  These changes come in the wake of a variety of medical advances, including human genomic testing and cancer drugs targeted for individuals with specific genetic profiles.

As public attention to understanding the human genome has increased, the topic has garnered substantial controversy and regulation in this sector is poised to increase.  The Food and Drug Administration (FDA) has already indicated its intent to regulate—most recently in a report clarifying its future role in personalized medicine and in warning letters to direct-to-consumer genetic testing companies.

The FDA maintains it has the authority to regulate personal genetic data because it defines that data as a medical device under Section 201(h) of the Food Drug & Cosmetics Act.  The agency also points to its role as the federal body charged with providing guidance on medical device claims and protecting consumers.

Some health scholars and consumers have weighed in on the propriety of regulation.  In a study of consumer attitudes toward regulating direct-to-consumer genetic testing, researchers found many consumers wanted unfettered access to genetics testing services without government regulation, but favored oversight to ensure that the information provided was high quality.

It's been tough to identify the problems that only turn up after medicines are on the market. An experimental project is now combing through data to get earlier, more accurate warnings.

No one likes it when a new drug in people's medicine cabinets turns out to have problems — just remember the Vioxx debacle a decade ago, when the painkiller was removed from the market over concerns that it increased the risk of heart attack and stroke.

To do a better job of spotting unforeseen risks and side effects, the Food and Drug Administration is trying something new — and there's a decent chance that it involves your medical records.

It's called Mini-Sentinel, and it's a $116 million government project to actively go out and look for adverse events linked to marketed drugs. This pilot program is able to mine huge databases of medical records for signs that drugs may be linked to problems.

The usual system for monitoring the safety of marketed drugs has real shortcomings. It largely relies on voluntary reports from doctors, pharmacists, and just plain folks who took a drug and got a bad outcome.

"We get about a million reports a year that way," says Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research. "But those are random. They are whatever people choose to send us."

Personalized medicine is the tailoring of a medical treatment to the individual characteristics, needs and preferences of a patient. Many recent advances involve using a patient's genetic information to guide his or her treatment.

Developing a truly personalized approach to patient care will require fundamental advances in the understanding of the biological, anatomical and physiological mechanisms that underlie disease, and how they are affected by environmental, genetic, social and cultural factors.

To describe its unique responsibilities and its efforts in facilitating the advancement of personalized medicine, the Food and Drug Administration (FDA) has released a new report entitled "Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development