US FDA calls on medical device makers to focus on cybersecurity

The topic of IT security and medical devices is a topic that draws my attention and this article from Networkworld did exactly that. I am going to quote the entire article before I continue with my post;

Medical device makers should take new steps to protect their products from malware and cyberattacks or face the possibility that U.S. Food and Drug Administration won’t approve their devices for use, the FDA said.

The FDA issued new cybersecurity recommendations for medical devices on Thursday, following reports that some devices have been compromise.

Recent vulnerabilities involving Philips fetal monitors and in Oracle software used in body fluid analysis machines are among the incidents that prompted the FDA to issue the recommendations, a spokeswoman for the agency said.

In one case reported in October, malware slowed down fetal monitors used on women with high-risk pregnancies at a Boston hospital, and in another case, the FDA in January issued a warning about Oracle software that could allow remote access to the databases of Roche Cobra analysis devices, she said.

Representatives of Philips and Oracle didn’t immediately respond to requests for comment on the FDA recommendations.

“Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches,” the FDA said in its recommendations. “As medical devices are increasingly interconnected, via the Internet, hospital networks, other medical device, and smartphones, there is an increased risk of cybersecurity breaches, which could affect how a medical device operates.”

Under proposed rules issued by the FDA, the agency is recommending that device makers provide it with their plans for providing updates and patches, said Erica Jefferson, an FDA spokeswoman.

“Once the guidance is finalized, the agency might consider withholding marketing clearance or approval for medical devices that fail to appropriately address cybersecurity risks,” she said.

The FDA is not aware of any patient injuries or deaths associated with cybersecurity incidents, the agency said. The agency doesn’t have “any indication that any specific devices or systems in clinical use have been purposely targeted at this time,” it said.

The FDA has seen medical devices infected or disabled by malware, and the presence of malware on hospital computers, smartphones and tablets, the agency said. The agency has also found health care providers with “uncontrolled distribution of passwords” and disabled passwords in software designed to have limited access, it said.

Other health care providers have failed to apply software updates and patches in a timely manner, the agency said.

The agency wants medical device makers to “take appropriate steps to limit the opportunities for unauthorized access to medical devices,” the FDA said in its recommendations. Manufacturers should review their cybersecurity practices to assure that appropriate safeguards are in place to prevent unauthorized access, the agency said.

Health care providers should also take steps to limit access and to improve cybersecurity, the agency said.

Ok, now here is my rant.

I first advocated about the issue with IT security and medical devices in 2003 and even delivered a lecture on the topic in 2005, at the 7th Annual NTU-SGH Symposium in Singapore.

If I start the counting with the year 2003, that means it has been 10 years since I have highlighted the problem. Now to explain why this topic still attracts my attention 10 years later on Рthe problem still exists, largely in its original form!

I took a quick look at FDA’s recommended “solutions” and it reminds me largely of those I made 10 years ago, which is kind of sad because it means nothing much has change from the development perspective, hence, still requiring pre-emptive measures in actual deployment environments.

I wonder if this will still remain the same 10 years from now?

Your thoughts?

 

Web-based tool charts disease, risk factors around the world

I would like to share an article from the Washington Post, on the utilisation of Data collected via web-based tools, to track disease and risk factors over the world (Public Health).

Do you see a trend here?

Interactive graphics showing how causes of death and disability, and risk factors for disease, differ between countries and change over time were unveiled Tuesday.

The information is from the massive Global Burden of Disease project produced by 488 researchers and 303 institutions in 50 countries. It provides health profiles of 187 countries and allows the user to compare a nation to its geographic, economic or cultural neighbors.

The screens are interactive. Users can key in 291 diseases and 67 risk factors and see how prevalence has changed since 1990.

The graphs and lists are likely to function as a report card for policymakers, a hypothesis-generator for epidemiologists and an alternative to solitaire for global health wonks. The data are used in a study appearing in the Lancet this week that compares Britain’s health with that of 15 other European countries over 20 years.

Microsoft co-founder and philanthropist Bill Gates provided $8.2 million for the 2010 update of the project, which began in 1993. Speaking Tuesday at an event in Seattle where the Web tools were unveiled, he said that ‚Äúit‚Äôs the areas where we go in and do a good job of measurement that we make the most progress.‚ÄĚ

The foundation that Gates and his wife, Melinda, run has spent $26 billion since 1997, most of it on improving health in developing countries.

The Global Burden of Disease project is led by Christopher J.L. Murray, a physician and economist at the Institute for Health Metrics and Evaluation at the University of Washington. The institute was created in 2007 with a $105 million grant from the Gates Foundation.

Murray and another researcher, Alan Lopez, produced the first Burden of Disease report in 1993. It introduced the concept of the ‚Äúdisability-adjusted life year‚ÄĚ (DALY), defined as the sum of years lost to premature death and years lived with disability.

Various disabilities ‚ÄĒ such as blindness, loss of a leg, chronic headaches, depression ‚ÄĒ were given the equivalents of fractions of a year of life lost. The idea was to go beyond mortality and capture how non-fatal illnesses also diminish life. Gates said he had an epiphany when he read the report and saw various health conditions described in terms of DALYs.

‚ÄúI was completely stunned by the burden of disease in poor countries,‚ÄĚ he said. ‚ÄúTo see that diarrhea was killing literally millions of children, and that some of those causes of diarrhea, like rotavirus, were preventable. .‚ÄČ.‚ÄČ. It was seeing that data, that early visualization that‚Äôs nowhere near what we‚Äôve got today, that got the Gates Foundation on the track of focusing on global health.‚ÄĚ

Researchers will add to the data at least annually.

Salford PhD student develops revolutionary elderly care robot

While the concept of having robots help in elder care isn’t a new one, this particular project at the¬†University of Salford caught my attention – because the robot can tell jokes!

Antonio Espingardeiro, who is studying in Salford Business School and the School of Computing, Science & Engineering, has created the P37 S65 robot which has the ability to remind elderly people to take their medication and exercise, and can even tell jokes. It can also provide 24-hour emergency notifications and will directly connect to carers or GPs through video conference or SMS.

As resources to care for the elderly become more strained, Antonio believes that his robot can supplement the intensive care required by many care home residents and conduct routine tasks without significantly reducing the human contact that people need. Crucially, one person can monitor many robots ‚Äď requiring fewer trained staff at each site.

In fact, based on his earlier studies in care homes he believes that his robot can actually improve quality of life for the elderly by promoting exercise, playing games and acting as a video link to family and loved ones. It will also support carers by following them around with meals and alerting them to emergencies and regular appointments.

His robot can be programmed with many routine health interventions that are designed for people with dementia ‚Äď such as speech therapy and object recognition exercises. Through face recognition it can also remember the preferences and requirements of each patient, as programmed at the instruction of a human worker.

Antonio conducted initial fieldwork with existing commercially available robots and discovered that residents found them to be highly stimulating and a break from their normal environment. He feels that, with his bespoke P37 S65, there is even more scope for the robot to support the work of human professionals in the exercise of care.

‚ÄúCare of the elderly is a difficult issue, but as populations age, we‚Äôre facing a difficult choice,‚ÄĚ he said. ‚ÄúDo we employ more people from a smaller workforce to care for us in our old age, or do we provide lower standards of care with fewer resources?‚ÄĚ

‚ÄúWith my robot I believe that we can avoid this problem. I‚Äôve already established that robots can provide meaningful interaction to supplement human contact, and from my work with care homes, I‚Äôve seen first-hand how both staff and residents benefit from their presence.‚ÄĚ

While Antonio now has a prototype he is looking for investment to conduct field trials and perfect the robot’s systems ahead of a full product launch.

To find out more about P37 S65 watch this demonstration video..

Sensor Network to Protect the Elderly

Applied Technology in¬†Geriatric Care is an interest of mine (so much so that I went on and completed a¬†Post Graduate Diploma in Geriatric Care last month) and this morning, an interesting article arrived in my inbox –¬†Marge Skubic from¬†University of Missouri-Columbia¬†¬†developed a remote sensor network to monitor seniors’ activity and baseline health.

Although the concept is nothing new, it is important to understand that research takes time so for¬†University of Missouri-Columbia to release this article, it means that the research took place way before (it’s important to set the context right).

The original article (with list of personnel involved) can be accessed via the National Science Foundation.

Many elderly dread the prospect that chronic medical issues will force them to leave their homes for an assisted living facility or nursing home, making them dependent upon others for their care and personal needs. Sometime in the near future, however, new technology could help them remain in their homes longer, perhaps indefinitely, without having to give up their independence.

“Our goal is to keep people in their private homes for as long as possible,” says Marjorie Skubic, professor of electrical and computer engineering at the University of Missouri. “The idea is to detect functional decline or early signs of illness, so we can identify problems when they are very small and proactively address them before they become catastrophic. That way, mom won’t have to leave her home.”

Skubic and Marilyn Rantz, a curator’s professor of nursing in the university’s Sinclair School of Nursing, have developed a sensor network that can remotely monitor changes in peoples’ activity patterns and baseline health conditions, and alert health professionals to early signs of illness and functional decline.

The beauty of the system is that it can be installed in peoples’ homes and monitored from afar, providing automated data that indicates the possible need for medical assistance, allowing the elderly to avoid unnecessary trips to clinics and doctors’ offices. This is significant advantage for older people, for whom travel often can be difficult, especially if they no longer drive.

While the ultimate aim is to place the system in private homes, the scientists currently are testing the sensor network in TigerPlace, a Columbia, Mo. eldercare facility operated by Americare. They recently received a National Science Foundation (NSF) grant to expand their research to Western Home Communities, a second location in Cedar Falls, Iowa. The researchers regard this as a first step toward implementing the system in independent housing, “where most seniors want to be,” Skubic says.

The equipment, which is installed in the home environment and passive for the individual, includes motion detectors, video gaming technology based on the Microsoft Kinect system that can monitor gait, and a newly developed hydraulic bed sensor that goes underneath the mattress and can measure an individual’s pulse, respiration and restlessness during sleep.

“We don’t expect the residents to do anything special,” Skubic says. “In fact, what we want is for them to be able to live their typical lifestyle pattern and go about their daily activities while, computationally, we are capturing a pattern that represents their usual behavior in their homes-and then we look for changes.”

The work is supported by a White House initiative, US Ignite, and NSF, the project’s lead federal agency, which aims to realize the potential of fast, open, next-generation high speed networks. US Ignite expands upon the NSF-funded Global Environment for Networking Innovation, or GENI, which is laying the technical groundwork for the program.

US Ignite is connecting a series of high-speed broadband resources to establish a “testbed” across universities and cities on a national scale, providing a fast, programmable “virtual laboratory” to allow academic researchers to experiment on future internets.

The in-home monitoring system designed by the University of Missouri researchers is among the first US Ignite grants funded by NSF through its EArly-concept Grants for Exploratory Research (EAGER) program.

“We’re monitoring people with lots of different ailments, such as diabetes, arthritis, hypertension and cardiac problems,” Skubic says. “First, we establish a baseline of behavior for each individual–we personalize it for each individual–so that we can look for deviations over time. If we see any, we send a health alert to the clinical staff.”

For example, motion detecting sensors, installed in every room and in other specific places, such as inside a refrigerator or kitchen cabinet, provide a measure of activity level.

“These sensors are set to generate an event every seven seconds,” Skubic says. “You get a sense of how active or sedentary a person is. If somebody sits in a chair for a good portion of the day, you get a low density, whereas an active person constantly moving around will generate a higher density. You can look at density for different hours of the day. The other thing the motion detectors can tell you is when someone leaves the house. If they stop going out, it could be an early detector of health problems.”

The Microsoft Kinect system, a gaming interface, allows the individual’s body to act as a “controller,” using a depth camera to record movement. The camera captures a three-dimensional silhouette that represents the moving body. The purpose is to assess gait, including walking speed and length of steps. Shorter footsteps, which can lead to slow walking speed, often can be an early indication of frailty and cognitive decline, and also increases the risk of falls.

“If you detect that somebody’s gait is changing, and they are at risk for a fall, you’d like to identify it, so you can provide some kind of intervention, such as physical therapy,” Skubic says. “If you can find muscle weakness or imbalance before they cause problems, exercises can be used to strengthen them”

The newest piece of the sensor package is the bed sensor, which “captures pulse and respiration rate and restlessness in bed,” she says. “If someone is not sleeping well, it can be an early sign of illness, or might be an indication of pain, or infection, or a breathing problem. For example, we’ve been able to detect a number of urinary tract infections before the resident even knows there is a problem because of restlessness and changes in bathroom patterns that show up at night-they get up more often-but the changes are so subtle, they don’t even realize it. But it’s really important to catch these early.”

When the sensor network detects changes, the system sends an automatically generated email to clinicians, “who can take a closer look at what’s going on,” Skubic says. “We rely on the clinicians to make the diagnosis and the clinicians have come to rely on the health alert system for early warnings. High resolution video conferencing is used to provide face time between the local clinicians and the residents in Iowa.”

The researchers see commercialization of the equipment as the next step, while they continue their testing. Moreover, they also are pursuing additional research ideas to improve the system, including additional sensors and new computer algorithms for better health alerts.

Eventually, they hope it will be more widely available, offering peace of mind for seniors, their family and their caregivers. “This has such a potential to proactively help seniors stay healthy and in their own homes, while at the same time saving healthcare costs,” Skubic says. “In the Cedar Falls site, we have installed these systems in apartments in a 100-year-old building. If we can install them there, we can install them anywhere.”

Ramblings: Carestream Digital Seminar 2012, Thailand

I was in Bangkok, Thailand last week, as the only invited speaker for a Carestream Digital Seminar titled “An affordable solution with big performance. What a brilliant combination.”

The topic I delivered is titled “Workflow Exploitation Via Architecture Optimization“, which as the title suggests, touches on architecture optimisation as part of clinical and operational workflow optimisation.

More than 300 participants attended the event and I was glad to see them paying close attention (and taking photos of my slides with their iPads) even though it was the last session of the day (I did a semi-workshop style lecture, hence I needed more than the standard 45 minutes presentation).

But what amazes me is the constant innovation that is being churned out by the medical imaging disciple.

While the following paragraph might sound like I’m trying to promote Carestream’s solution, it really is just because they truly have something awesome.

No, its not just their RIS and PACS (plus VNA) but it is their DR retrofit kits (which I think is an awesome concept) but also their latest offerings Рthe DRX-Revolution.

The medical imaging segment is indeed an innovative bunch.

EastWest Institute Proposes Public Health Model For Internet Cybersecurity

I came across an article that is in-my-humble-opinion,  rather interesting.

The article starts off with the following paragraph;

Just as computers get viruses, cybersecurity professionals should consider establishing a framework to surveil and monitor networks’ health worldwide based on a global public health model, an international cybersecurity think thank proposed in a recent report.

Surely that’s an innovative approach to ensuring ‘Community Health’ in cyberspace and what approach can be better than models adopted in Public Health to monitor Community Health!

Granted that the model would not be a perfect fit (the article briefly examines various angles ¬†to the approach so I’m not going to bored you with additional analysis) but viewing the approach from both sides of the coin (I hold an qualification in Infocomm Security and am in the midst of my MPH, among other¬†endeavours of¬†knowledge-pursuit), I do see a high degree of co-relation between the two disciplines.

For the interested, the original article can be accessed here and the actual report, here.

(I’ve not read the full report yet but I promise to ūüôā )

Australia to launch one-stop online gateway for aged care

I got this piece of news from FutureGov.

Seems that the Aged Care market is indeed the next ‘big thing’.

The Australian Government is launching an internet portal tracking aged care services, while streamlining access to information about nursing homes, staffing levels, amenities and community care services.

This My Aged Care internet portal, to be supported by dedicated phone services, goes live in early 2013. It is part of a US$3.84 billion (AUD$3.7 billion) reform agenda designed to overhaul aged care services in Australia.

For the first time, the My Aged Care portal will feature a star rating system for nursing homes and other aged care services, including any previous history of complaints or feedback about the quality of care.

The government is introducing a single information-access gateway to consolidate information about services, according to the Minister for Ageing, Mark Butler.

He said the My Aged Care website will offer detailed information about aged care providers, available services, amenities, staffing levels, fees and other charges.

This on-line gateway will enable families and older Australians to compare and make informed choices about the quality of available care and affordability.

The My Aged Care web site is the latest internet portal that caters for specific communities, including the MySchool, MyHospital, and MyUniversity web sites.

Australian Prime Minister Julia Gillard said Australians are living longer; this has implications for how the government runs its aged care program.

The latest reform tackles long-standing concerns about the quality of aged care in Australia affecting elderly and often poorly-informed residents.

‚ÄúWe now have a new generation moving into retirement, the baby boomers, who will clearly want more options and choices than older Australians have sought in the past,‚Ä̬†PMGillard¬†said.

‚ÄúFamilies can‚Äôt get the information they need to make difficult¬†choices.‚ÄĚ

Australia’s system of monitoring and compliance needs to be overhauled to give would-be residents and their families a true picture of nursing home quality.

‚ÄĚNow it‚Äôs just about putting a tick or cross in a box; all residents or family members should be asked their views for a¬†start.‚ÄĚ

Internet-savvy baby boomers are changing perceptions about ageing; they also expect better information and choices about the quality of care, nursing homes, and other facilities.

Australia‚Äôs aged care services are severely stressed ‚Äď with many Australians forced to sell homes under ‚Äúfire sales‚ÄĚ to finance their need for¬†care.

Commercially-run nursing homes are under scrutiny about the quality of services, while being expensive to finance for families seeking services for parents or elderly relatives.

More disturbingly, 40 per cent of older Australians are forced into emergency fire sales of their homes, according to PM Gillard.

These sales are to raise money to pay for care. At the top end, these bonds can cost as much as US$2.6 million (AUD$2.5 million), and bear no resemblance to the cost of accommodation being provided in nursing homes.

PM Gillard said Australia’s overhaul of aged care services, and improved information access, will give older Australians and their families greater choice and control than they’ve had in the past.

So what exactly is Public Health?

I had a conversation with a friend a couple of days ago on the topic of Public Health and he was pretty¬†astonished¬†when I mentioned that the completion of a MPH – Masters in Public Health (I’m currently in the midst of ¬†one, out of personal interest) will not make one an expert in the area.

When asked to explain the differences between Public Health and Clinical Medicine, I’d usually point out that Public Health looks at the Community while Clinical Medicine looks at the individual.

Earlier this morning, I found a much better illustration which I have decided to share here:

Public Health Medicine
Primary Focus Populations Individuals
Emphasis Prevention Diagnosis
Health Promotion Treatment
Whole Community Whole Patient
Paradigm Interventions aimed at Environment, Human Behavior and Lifestyle, and Medical Care Medical Care
Organizational Lines of Specialization Analytical (Epidemiology); Organ (Cardiology);
Setting and Population (Occupational Health); Patient Group (Pediatrics);
Substantive Health Problem (Nutrition); Etiology, Pathophysiology (Oncology, Infectious Disease)
Skills in Assessment, Policy Development, and Assurance Technical Skill (Radiology)
[Adapted from: Fineberg, Harvey, MD, PhD, Dean, Harvard University School of Public Health, 1990. Traditional Distinctions Between Public Health and Medicine. Table 5-1, Who Will Keep the Public Healthy? Educating Public Health Professionals for the 21st Century. Institute of Medicine, 2003.
http://www.nap.edu/books/030908542X/html/]

While the table above illustrate the distinct differences between Public Health and Clinical Medicine, it does not explain why the completion of a MPH will not make one an expert on the area of Public Health.

Public Health considers interventions aimed at Environment, Human Behaviour and Lifestyle, and Medical Care (not just medical care) and being such a wide  interdisciplinary field of study and research, there are twenty identified knowledge domains within public health. They are:

  • Biostatistics
  • Chronic Diseases & Conditions
  • Community Health
  • Communicable Diseases
  • Disaster Control & Emergency Services
  • Environmental Health
  • Epidemiology
  • General Public Health
  • Global Health
  • Health Services Administration
  • Health Promotion & Education
  • HIV/AIDS
  • Maternal & Child Health
  • Nutrition
  • Occupational Health
  • Public Health Informatics
  • Public Health Laboratory Sciences
  • Public Health Nursing
  • Social & Behavioral Sciences
  • Vital Statistics & Surveillance

It is important to understand that one can do a Master degree on any of the listed identified knowledge (and in some cases, even subdomains within the domains).

Yes, Public Health is a big topic and I personally think that its an important one, after all, Prevention is better than Cure!

ElectroCardiographic Imaging (ECGI)

Just to share an interesting development in Medical Imaging that I read earlier at ImagingEconomics.com

A new technique in development may provide more accurate details than conventional methods about how the heart beats, and what goes wrong when it’s off beat.

###

In a healthy adult at rest, the heart beats 60 to 100 times a minute. In an unhealthy heart, this beat can vary, and the rate or rhythm can be thrown off. This condition is known as an arrhythmia and can refer to a beat that is too fast (tachycardia), too slow (bradycardia) or off rhythm.

There are four main types of arrhythmias, and a number of specific disorders. The most common is atrial fibrillation, which impacts an estimated 2.2 million people in the US and accounts for roughly one-third of hospitalizations for cardiac rhythm disturbances. A joint task force of the American College of Cardiology and the American Heart Association analyzed associated costs and found that the disease incurs $3,600 per year per patient, making it a costly public driver (approximately $15.7 billion).

Unfortunately, it has been difficult to fully understand the beating heart without opening up the chest. The primary method to diagnose heart rhythm disorders has been the electrocardiogram, also known as the ECG or EKG. The method uses electrodes placed on the skin to indirectly measure the electrical activity in the heart.

‚ÄúThe ECG is an extremely useful tool, which has been with us for more than a hundred years. It‚Äôs practical. It‚Äôs cheap, relatively speaking. It‚Äôs easy to apply. But it has severe limitations because you are measuring a reflection of the electrical activity of the heart‚ÄĒfar away from the heart,‚ÄĚ says Yoram Rudy, PhD, the Fred Saigh distinguished professor of engineering; professor of biomedical engineering medicine, Cell Biology and Physiology, Cardiology, and Pediatrics; and director of the Cardiac Bioelectricity and Arrhythmia Center, at Washington University in St Louis (Mo).

Rudy is part of a team that has been working on a new technique, called electrocardiographic imaging or ECGI, for non-invasive mapping of a patient’s heartbeat for nearly 30 years. Supported by grants through the National Institute of Health, it has recently published papers on the use of this experimental methodology in atrial fibrillation and ventricular tachycardia (fast, regular beating that may last for a few seconds or longer).

Proven Research Value, Potential Clinical Use

The new technique combines a more extensive EKG (250 electrodes rather than the typical 12) with a thoracic CT scan, which captures images, including the electrode positions, of the chest and upper abdomen. ‚ÄúWe then use mathematical and computer algorithms in a mathematical and physical approach that we have developed over many years,‚ÄĚ Rudy says.

In the latest study looking at ventricular tachycardia, the researchers were able to use ECGI to map the activation sequence in the heart and identify the location and depth of the disorder’s origin in individual patients. They concluded that the method improved significantly upon the data available through a more conventional EKG.

In general, the information collected using ECGI has proven to be extremely useful for both research and clinical purposes, though the system is still in experimental stages. The University of Wisconsin is implementing the technique through research trials looking at a number of different issues (another paper addressing the association between heart attack, arrhythmia, and risk is expected out in October).

Ultimately, ECGI is intended for use as a clinical tool, one that will provide an advanced, non-invasive imaging technique for assessing cardio-electrical activity and rhythm disorders in the heart. ‚ÄúIt can be used as a tool for diagnosis‚ÄĒprecise diagnosis of an arrhythmia mechanism‚ÄĒand once a diagnosis is made, for therapy guidance and follow up,‚ÄĚ Rudysays.

Rudy notes that a commercial effort is underway through CardioInsight Technologies, Inc, in Cleveland, Ohio. The corporate leaders were former PhD students under Rudy, and he sits on the company‚Äôs scientific advisory board. ‚ÄúIt‚Äôs not available as a clinical tool yet, but once it is FDA approved and available, I believe it will have widespread use,‚ÄĚ Rudy says.

FDA issues draft guidance on mobile medical apps

That’s right folks, FDA has finally release the draft guidelines (original story from¬†CMIO.net)

The FDA has released, for comment purposes, draft guidance on mobile medical applications. The 29-page draft, issued July 21, contains nonbinding recommendations ‚Äúto inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms,‚ÄĚ the draft stated.

The draft includes definitions of mobile platforms, mobile applications, mobile medical applications, regulated medical devices and mobile medical application manufacturers, as well as the scope of the FDA’s plans, regulatory approach for mobile apps and regulatory requirements.

The FDA plans to focus only on a subset of mobile apps that either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device.

This subset, which the agency is calling mobile medical apps, includes only those that meet the statutory definition of a device; and either are used as an accessory to a regulated medical device, or to transform a mobile platform into a regulated medical device.

‚ÄúThis guidance does not specifically address wireless safety considerations, classification and submission requirements related to clinical decision support software or the application of quality systems to software. The FDA intends to address these topics through separate guidance(s)‚ÄĚ the draft stated.

The following examples represent mobile apps that the FDA considers to be subject to its regulatory oversight:

  • Mobile apps that are an extension of one or more medical device(s) by connecting to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing or transmitting patient-specific medical device data.¬†Examples of displays of patient-specific medical device data include remote display of data from bedside monitors, display of previously stored EEG wave forms, and display of medical images directly from a PACS server; or similar display functions that meet the definition of an MDDS.
  • Mobile apps that transform the mobile platform into a medical device by using attachments, display screens or sensors or by including functionalities similar to those of currently regulated medical devices.¬†Examples include a mobile app that uses a mobile platform for medical device functions, such as attachment of a transducer to a mobile platform to function as a stethoscope, attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter, or attachment of¬†electrocardiograph¬†(ECG) electrodes to a mobile platform to measure, store, and display ECG signals; or, a mobile app that uses the built-in accelerometer on a mobile platform to collect motion information for monitoring sleep apnea.
  • Mobile apps that allow the user to input patient-specific information and‚ÄĒusing formulae or processing algorithms‚ÄĒoutput a patient-specific result, diagnosis or treatment recommendation to be used in clinical practice or to assist in making clinical decisions. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.
  • Click¬†here¬†to see the draft guidelines.