A meeting of government officials reveals that medical equipment is becoming riddled with malware.
In a typical example, at Beth Israel Deaconess Medical Center in Boston, 664 pieces of medical equipment are running on older Windows operating systems that manufactures will not modify or allow the hospital to change—even to add antivirus software—because of disagreements over whether modifications could run afoul of U.S. Food and Drug Administration regulatory reviews, Fu says.
As a result, these computers are frequently infected with malware, and one or two have to be taken offline each week for cleaning, says Mark Olson, chief information security officer at Beth Israel.
"I find this mind-boggling," Fu says. "Conventional malware is rampant in hospitals because of medical devices using unpatched operating systems. There's little recourse for hospitals when a manufacturer refuses to allow OS updates or security patches."
The worries over possible consequences for patients were described last Thursday at a meeting of a medical-device panel at the National Institute of Standards and Technology Information Security & Privacy Advisory Board, of which Fu is a member, in Washington, D.C. At the meeting, Olson described how malware at one point slowed down fetal monitors used on women with high-risk pregnancies being treated in intensive-care wards.
The abbreviations, acronyms, and words included in this glossary represent medical device and procedure terminology found in everyday practice. Also included are many colloquial terms and abbreviations frequently encountered on requisitions for radiologic services or in daily conversation. These terms were purposely included because they are often not defined in standard medical texts or dictionaries. The definitions presented herein are the authors’ own, but we believe they conform to general usage. Some meanings vary from locale to locale and from specialty to specialty. Often, terms now in general medical usage originated from the name of a manufacturer or inventor of a particular device. Over time, these terms have acquired a generic meaning of their own, now being applied to a class of devices with the original meaning lost. Examples of this phenomenon include the Jackson-Pratt drain, the Hickman catheter, the Broviac catheter, the Swan-Ganz catheter, the Dobbhoff tube, and the Kirschner wire.
It is surprising that many such terms are not defined or even listed in leading medical specialty textbooks. The package inserts supplied with devices frequently do not cite references that deal with the device’s origin, even when the device carries an inventor’s name. There has also been a recent pernicious increase in the nonstandardized use of common abbreviations in requests for radiologic procedures. Prime examples include the abbreviations ASD and USA. ASD used to mean “atrial septal defect.” Now, it sometimes means “airspace disease.” USAused to mean the United States of America, but some use it to mean “unstable angina.”
The definitions and terms included in this glossary are derived from the authors’ own experience, from discussions with many colleagues, and from information contained in many excellent medical terminology texts. This glossary is also an extension of glossaries found in Radiologic Guide to Medical Devices and Foreign Bodies (St Louis, Mo: Mosby–Year Book, 1994) and Medical Devices, Abbreviations, Acronyms and Eponyms: A Pocket Guide (St Louis, Mo: Mosby, 1994).
The FDA is warning that implanted medical devices, such as pacemakers and defibrillators, are often connected to networks that are vulnerable to cyber attacks that could shut down or manipulate the machinery.
Medical devices seem to get smaller every year. Think of something as simple as a pacemaker or hearing aid. Like their bretheren PCs, these gadgets that help enhance and extend our lives continue to shrink.
"The current EU regulatory framework for in vitro diagnostic medical devices ('IVDs') consists of Directive 98/79/EC of the European Parliament and of the Council ('the IVD Directive') IVDs cover a wide range of products that can be used for population screening and disease prevention, diagnosis, monitoring of prescribed treatments and assessment of medical interventions.
Like Council Directive 90/385/EEC on active implantable medical devices (AIMDD) and Council Directive 93/42/EEC on medical devices (MDD) the IVD Directive is based on the 'New Approach' and aims to ensure the smooth functioning of the internal market and a high level of protection of human health and safety. IVDs are not subject to any pre-market authorisation by a regulatory authority but to a conformity assessment which, for the majority of devices, is carried out under the sole responsibility of the manufacturer. For the high-risk devices listed in Annex II and devices for self-testing, the conformity assessment involves an independent third party, known as 'notified body'. Notified bodies are designated and monitored by the Member States and act under the control of the national authorities.
Once certified, devices bear the CE marking which allows them to circulate freely in the EU/EFTA countries and Turkey. The existing regulatory framework for in vitro diagnostic medical devices has demonstrated its merits but has also come under criticism in recent years. In an internal market with 32 participating countries and subject to constant scientific and technological progress, substantial divergences in the interpretation and application of the rules have emerged, thus undermining the main objectives of the Directive, i.e. the safety and performance of IVDs and their ..."
Barnaby Jack, a programmer and hacker who gained worldwide recognition and respect for numerous technical feats including hacking medical implants and hijacking an ATM (cash machine) and forcing it to spit out money, was found dead on Thursday evening in an apartment in San Francisco, as Reuters reported. According to Reuters, a police spokesperson said that "foul play" was not suspected in Jack's death. But the report states that an autopsy is being performed, and that the results are anticipated within a month. Jack was reportedly 35.
Hacking Insulin Pumps And Other Medical Devices - Reality Not Fiction Forbes One of the briefings at Black Hat this year was a session on how vulnerable medical devices are to cyber attack, given by Jay Radcliff.
An article in The New York Times reports on the high costs of joint replacement in the United States compared to other developed countries. These procedures are “many more times” as expensive in the United States than they are in other countries.
If there’s one thing we can always count on in the medical device world, it’s the steady beat of progress. We look for the big idea that will save lives, make doctors’ jobs easier and the medical field more efficient — thus saving costs. As designers, we keep our eyes on innovations in the medical device world. Here are three trends that are making an impact.
Making medical devices smaller and portable
Access to effective care often requires medical devices which are smaller, lighter and more portable. In order to go big, we need to think small. Interestingly, this trend is prevalent in both resource poor and resource rich healthcare systems
The drive towards earlier and more accurate diagnosis
Current cancer detection and monitoring methods can be extremely invasive or poorly targeted, resulting in low treatment efficacy and unpleasant side effects
Using data for prevention
There is a growing desire for medical devices — including those that are wearable — to track and monitor personal health. There are countless smart phone apps that track health-related issues, such as restful sleep, exercise, and diet. The current trend is towards devices that support and tap into our increasingly endless desire for more information.
Tiny sensors and motors tell your smartphone screen to rotate and your camera to focus. But now researchers have found a way to print biocompatible components for these micro-machines, making them ideal for use in medical devices like bionic arms.
Two cyber security schemes have been launched today to provide industry expertise to victims of cyber-security attacks (Government partners with #security services to launch #Cyber Incident Response schemes http://t.co/fWnV48hzic)...
A family in Houston in the US apparently had their child's baby monitor camera hacked, after insulting phrases emanated from the unit. (RT @Sigman_Law_Firm: Now people are hacking into baby monitors? What is wrong with people?