HHS issues Final Rule For Certified Health Information Technology

October 21, 2016

The U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) issued a final rule that emphasizes the importance of protecting public health and safety while also strengthening transparency and accountability in the ONC Health IT Certification Program (“Program”).

The “ONC Health IT Certification Program: Enhanced Oversight and Accountability” final rule will enable the ONC Health IT Certification Program to better support physicians and hospitals – the vast majority of whom use certified electronic health records (EHRs) – and the rapid pace of innovation in the health information technology (health IT) market.

“More transparency and accountability in health IT is good for consumers, physicians, and hospitals,” said Vindell Washington, M.D., M.H.C.M., national coordinator for health IT. “Today’s final rule strengthens the program by ensuring that certified health IT helps clinicians and individuals use and exchange electronic health information safely and reliably.”

CLICK HERE to see the original article



6 Contributing Factors to Patient Falls and How to Address Them

October 20, 2016

A report released by the Health Research & Educational Trust outlines how five major hospitals reduced overall falls by 35 percent.

October 6, 2016

Preventing patient falls is a pain point for many hospitals. But, a report released  by the American Hospital Association’s Health Research & Educational Trust offers five hospital case studies that may help others to reduce falls.

The report, Preventing Patient Falls: A Systematic Approach from the Joint Commission Center for Transforming Healthcare Project saw seven U.S. hospitals use a “robust process improvement approach” consisting of tools from Lean Six Sigma as well as change management methodologies to reduce falls with injury on pilot units within their facilities.

Five of the seven hospitals submitted data from the project and, on average, the organizations reduced the falls with injury rate by 62 percent, which was accompanied by a 35 percent reduction in the overall falls rate. If the robust process approach is applied to a typical 200-bed hospital, staff can expect 72 fewer injuries and $1 million in costs saved, the report states.

The report grouped the top 10 contributing factors for falls into six categories:

  1. Fall risk assessment issues
  2. Handoff communication issues
  3. Toileting issues
  4. Call light issues
  5. Educational and organizational culture issues
  6. Medication issues

The importance of identifying and addressing patient falls cannot be understated. An estimated 700,000 to 1 million people fall in U.S. hospitals each year, with 30 to 35 percent of those sustaining injuries, according to the project report.

Below are brief summaries of the five case studies from hospitals that participated in the project. Read the full report here.

Bassett Medical Center, Cooperstown, N.Y.

The team developed an educational effort across the unit, which included a fall safety document that patients, staff and family members review to assess the patient’s fall risk and steps that staff can take to prevent falls. The 180-bed medical center created a “Call, Don’t Fall” campaign, placing signs in patient rooms as a reminder to call for help before leaving their beds.

Two daily huddles were implemented to address falls associated with toileting. During the huddle, high-risk patients are identified and receive assistance with toileting every two hours.

All these efforts led to a 43 percent reduction of falls in the medical unit. Fall huddles now take place immediately after a fall and weekly team reviews are held to look at trends and take steps to address issues.

Baylor Scott & White Medical Center, Garland, Texas

The unit was already using yellow socks and gowns to identify at-risk fall patients, but after identifying communication as an issue, implemented a specific worksheet for the nurse and primary care technician.

Falls were reported in older men who were not using the call light for toileting. After talking with these patients, it was found that they did not feel comfortable being helped by young nurses, who reminded them of their daughters and granddaughters. For this specific demographic, patients were advised that a male member of the staff would assist them when available.

Educational materials were revised, including the patient acknowledgement form and materials were printed in English, Spanish and Vietnamese, and with a third-grade vocabulary reading level. The patient acknowledgement form includes a 16-item checklist that is discussed between the nurse and patient upon admission to the floor.

Although the medical-surgical unit had a small population regarding falls and falls with injury, the unit was able to use post-fall assessments to identify contributing factors and drill down to root causes. The med-surg- unit has reduced falls with injury and the medical center has spread the solutions and ideas to other units in the medical center.

Kaiser Permanente Zion Medical Center, San Diego

After determining that most falls occurred when patients left their bed without assistance, a unit-based approach was taken that involved full engagement of front-line unit staff, going beyond nursing to include environmental services staff, physicians and others. The culture has shifted to a “no one walks alone” mentality.

Education of families and patients occurs upon admission about the danger of falls, along with hourly rounding during which patients are offered bathroom assistance and help to reposition themselves.

Each shift begins with unit huddles and two hours later, changes and observations are reviewed. A falls committee with membership across the hospital was created to instill ownership in clinical areas.

Memorial Hermann Memorial City Medical Center, Houston

The focus of this study was on its cardiology unit and addressed 16 root causes of fall injuries. An important finding was that the tool used to measure a patient’s risk for falls provided inconsistent ratings and variation in assessment.

Older men were determined to be more at risk for falls and were not aware of their increased risk after hospitalization. The hospital implemented consistent patient education and standardized fall safety messaging, focusing efforts on older patients in the cardiology unit. Post-fall meetings also were implemented to discuss immediate interventions and lessons learned.

The rate of falls on the cardiology unit decreased 50.5 percent during the project, and falls with injuries decreased 49.2 percent. The team made a video of best practices and a checklist of critical steps for patient safety to share with the rest of the hospital.

Wake Forest Baptist Medical Center, Winston-Salem, N.C.

A project team recruited from across the organization determined a set of five root causes to address. After looking at medication management, team members found an opportunity to ensure that patients on diuretics receive their medication at least two hours before bedtime.

The team also confirmed that impaired mobility and impaired cognitive function were key risk factors for falls. The team undertook a successful intervention in the oncology unit that involved routine mobility and activity with an aide, physical therapy focused on balance, and strengthening exercises. The average change from baseline to pilot period showed a 27 percent reduction in falls and a 59 percent reduction in falls with injury.

A video monitoring system was installed to identify high-risk patients, and a video technician monitored as many as eight patients from the nurses’ station 24/7. Patients being monitored had a 16 percent reduction in falls and a 41 percent reduction in falls with injury.

Service Contract Pricing: TVs

October 19, 2016

[This article from Warranty Week shows how the pricing of consumer goods service contracts parallels that of medical equipment costs, when COSR (Cost of Service Ratio) is the metric of comparison.  Pat Lynch]

Although the average price of a TV service contract is 17% of the TV’s price, there is a tremendous amount of variation. One administrator wants $30 to protect a $400 TV while another wants nearly 2/3rds the price of a high-end Sony set for a service plan.

‘Tis the season for retailers to make their numbers, and it’s been quite a few years since we gathered any data on the price of the service contracts that retailers so dearly love to sell with all their products. So this week we’re beginning a process where we look at the relative prices of the products and the service contracts on offer this season, with an eye towards figuring out what the actuaries already know: what’s the break-even price of a protection plan?

We decided to start with flat-screen televisions, which in years gone by were the bread and butter of the service contract industry. The process started with an online mystery shopping exercise at 11 major television retail chains: Amazon.com Inc., Best Buy Co. Inc., Costco Wholesale Corp., hhgregg (Gregg Appliances Inc.), Micro Center (Micro Electronics Inc.), Newegg Inc., Sam’s Club, Sears Holdings Corp., Staples Inc., Target Corp., and Wal-Mart Stores Inc.

We sought out at least three 50-inch or 55-inch flat screen televisions from each, aiming to include a unit priced below $500, a unit priced between $500 and $1,000, and one priced above $1,000. But it wasn’t always possible to do so. To reduce the amount of variables, such as the variations in loss cost between different makes and models, we aimed for a low-end unit made by either TCL Corp. or Vizio Inc., a midrange unit made by Samsung Electronics Co. Ltd., and a high-end unit made by Sony Corp.. But these brands were not always available from every retailer, so there were some LG units mixed in when necessary, and even some Kenmore-branded televisions. Then we sought out offers of service contracts with terms between one and five years.

Service Contract Administrators

Over the course of going through the offerings of 11 retailers, we came across seven different obligor/administrator/underwriter teams. We found Service Net and AIG at Best Buy and newegg.com; Warrantech, AMT Warranty and AmTrust Financial Services Inc. at hhgregg; and Asurion and CNA Financial Corp. at Target and Walmart. Micro Center had The Warranty Group, and Sears had its own in-house operation. SquareTrade was in Costco, Sam’s Club, and Staples. And depending upon the TV we looked at, Amazon.com had a competitive mix of plans from AmTrust, Assurant Solutions, and SquareTrade.

In all, we found 75 pairings of televisions and service contracts, with prices that ranged between $288 and $1,700. While most were 50-inch or 55-inch units, there were nine with screen sizes between 40 and 49 inches, and one that had a 60-inch diagonal screen size. But what was more important was that there be a balance in the price of the TV. We wanted both low-end and high-end units, as well as lots of mid-priced TVs.

As can be seen in Figure 1, of the 75 TV-service contract pairings, there were 25 with retail prices under $500, 22 with prices above $1,000, and 28 in between. We did not include either shipping, delivery or set-up costs in the price, and we did not include sales tax.


Figure 1
Price of Televisions Surveyed


For the accompanying service contracts offered with these TVs, we noted three metrics. First, we noted the term of the service contract in years. Second, we noted whether the contract was in effect from the date of purchase, or from the date the manufacturer’s product warranty expired. Third, we noted the price of the contract.

In Figure 2, we’ve charted the results of the first metric. There were 13 service contracts that offered one or two years of coverage. Another 26 offered three years. There were 14 four-year offers, and 22 five-year offers. None were longer.


Figure 2
Length of Service Contracts Offered


Out of the 75 pairings, we found that 59 were effective from the date of purchase. In other words, they overlapped the product warranty, offering better coverage with perks such as free shipping to and from the repair center, cracked screen protection, surge protection, or some other peril not covered by the product warranty.

Only 16 took effect from the date of the expiration of the product warranty. And, we note, most of these were offered by SquareTrade Inc., through outlets such as Costco, Amazon.com, or Sam’s Club. And, we further note, Costco provided buyers with a two-year product warranty, above and beyond the one-year warranties typically offered by the TV manufacturers.

In those instances, Costco offered two years of coverage, and SquareTrade offered an additional three years of coverage, for a total of five consecutive years of coverage. Interestingly, SquareTrade’s service contracts at Staples were effective on the date of purchase, unlike the others.

The reason we mention this is because we found SquareTrade to have some of the lowest service contract prices of all, compared to the price of the product they were covering. The spread ran from 3% to 66%, but SquareTrade had half of the 22 offers where the service contract was priced under 10% of the product’s price.

And at the other extreme, we noted that the three highest percentage pairings all belonged to Sears. For instance, the company sells the Sony model XBR55X900B 55-inch television for $1,390, and also offers a five-year service contract for $920. That means the service contract costs nearly two-thirds as much as the product it protects.

Granted, Sears Protection Agreements are in a class of their own. For instance with no buy-outs, the product could be replaced once a year for five consecutive years without terminating the service contract, because each of the replacements would also be covered until the original five years was up. Most other providers would say the contract is fulfilled after the first replacement or major repair.

Therefore, in the four charts below, we’ve noted the high and low-priced service contract providers. SquareTrade is noted in blue squares. Sears is noted in red triangles. And all the others — AIG, AmTrust, Assurant Solutions, Asurion/CNA, and The Warranty Group — are noted in plain gray diamonds.

Short-Term Service Contracts

In Figure 3, we’ve charted the 13 one- and two-year service contract offers. The price pairings ranged from a low of $37 for a two-year Electronics Protection Plan provided by SquareTrade on a $1,199 Samsung TV at Staples (3.1%) to an $80 two-year plan provided by AmTrust on a $350 LG unit at hhgregg (23%).


Figure 3
One- and Two-Year Service Contracts
Price of Service Contracts Offered
(as a percentage of TV price)


The average cost of a two-year plan was 11% of the TV price. Therefore, in this group, there were seven offers below average, and six offers above average. Three of the below-average offers came from SquareTrade. Sears did not offer any two-year plans. In this chart, the outlier to the extreme right was a $200 Geek Squad Protection Plan offered by AIG on a $1,700 Sony TV at Best Buy. But while the contract price was high, the ratio was merely average (12%).

We could have charted the results based on the price of the TV instead of by the duration of the accompanying service contract. But the results would not have changed by much. Of the 25 TVs priced under $500, service contracts ranged from 7% to 43% of the product price, with an average of 19%. Of the 22 TVs priced over $1,000, the offers ranged from 3% to 66%, with an average of 16%. And in the midrange, the offers ranged from 4% to 43%, with an average of 16%.

Therefore, any way you slice it, you are likely to find that there’s quite a bit of variation in the price of service contracts compared to the price of the products they cover. However, based on 75 measurements, the average price of a service contract is around 17% of the TV’s price.

Three-Year Service Contracts

The three-year plans were the most numerous of all. As can be seen in Figure 4, the 26 pairings ranged from a 4% offer by SquareTrade on a Samsung at Staples to a 45% offer by Sears for a high-end Sony model.

However, also note that Sears had a pair of offers that were closer to the consensus. A low-end Kenmore TV selling for $400 had a $95 service contract offer (24%) while a midrange Samsung had a $230 service contract offer (29%).


Figure 4
Three-Year Service Contracts
Price of Service Contracts Offered
(as a percentage of TV price)


There was a noticeable cluster of service contract pricings at the $95, $99, and $120 levels. This was caused by the tendency of some service contract providers to use bands of product prices to determine the cost of the service contract. For instance, any TVs priced below $500 had one service contract price, while others priced between $500 and $1,000 had another price. In other words, the service contract prices were not based on the frequency or severity of the repairs or replacements. Rather, they were averaged based on the selling price of the covered product.

Four-Year Protection Plans

In Figure 5, the big surprise is the complete absence of any SquareTrade or Sears offers. We should note that technically, the SquareTrade offers in Sam’s Club were for only four years, but members got the fifth year free. And since the retailers cater to club members, we assumed that most buyers were getting five-year plans.


Figure 5
Four-Year Service Contracts
Price of Service Contracts Offered
(as a percentage of TV price)


Among these 14 offers, the service contract prices ranged from $39 to $200 while the TV prices ranged from $378 to $1,698. Therefore, the ratios ranged from a low of 7% (a $58 offer by Assurant on a Samsung at Amazon.com) to a high of 35% (a $150 offer by AIG on a $428 Vizio model at newegg.com).

The average was 15%, which was lower than either the three- or five- year average. This might have something to do with the fact that three of the plans were warranty extensions while 11 started on the day of purchase.

And again, notice the cluster of service contracts offered at the $150 price point. Once again, this is a product of the band pricing adopted by several administrators, where the service contract for any TV priced between X and Y gets a Z price tag. Since there will be several TVs priced between X and Y, there will be numerous instances of Z, in this case, $150.

The Five-Year Plans

Finally, we have 22 five-year plans to discuss. In Figure 6, like in Figure 4, we once again see Sears in the upper right and SquareTrade in the lower left. The difference is, this time 13 of the 22 offers are from SquareTrade, while three are from Sears and six are from AIG or AmTrust. The average ratio is 21%, and all of the SquareTrade offers are below it, while all of the AIG, AmTrust and Sears offers are above it.


Figure 6
Five-Year Service Contracts
Price of Service Contracts Offered
(as a percentage of TV price)


As was mentioned, Sam’s Club gives a free fifth year of service contract coverage to members who buy four-year plans, and Costco gives a free second year of product warranty coverage to its members. The first drives up loss cost, while the second diverts at least a year’s loss cost from the service contract provider to the retailer. And we also note that of the 16 instances where coverage begins after the product warranty expires, 13 of those are in this category (the other three were in the four-year cohort).

Shopping Expedition Continues

It’s early days in our online mystery shopping expedition, so we’re not going to draw too many conclusions here yet. Our plan is to spend the weeks ahead looking at service contract prices paired with several different kinds of electronics, computers, fitness equipment, and household appliances. We want to find the averages and the extremes, and see if they fit any particular pattern.

In last week’s newsletter, we detailed many of the reasons that the 2006 advice of Consumer Reports to not buy extended warranties no longer holds. Here’s an additional reason: if a reputable obligor is willing to protect a $1,500 television from defects and even damage for five years for only $100 (which in many states would be less than the sales tax), and if they’re willing and able to pay all legitimate claims, who’s to say that’s a waste of money?


5 Essential Incident Response Checklist

October 18, 2016

Top Five Incident Response Checklists

Click through for the top five response checklists every organization should have ready to go (and up to date) when a security incident occurs, as identified by AlienVault.

Data breaches have become an unfortunate reality for most companies. If you haven’t already experienced one, just wait. Whether state-sponsored or committed by an individual, hacking and the resulting loss of data, reputation and business profit must be a top priority for all organizations. And while it’s important to keep up with the latest technologies to mitigate breach potential, it’s equally as important to be ready to handle a breach once it occurs. A good way to do that is with incident response checklists.

When a security breach occurs, IT teams that are armed with incident response checklists will be better prepared to execute a fast and effective response. Good incident response checklists address particular scenarios and break down critical tasks into smaller pieces. They also help responders document everything that happens in an accurate, standard, and repeatable way. In this slideshow, AlienVault has identified the top five checklists that IT teams should have ready to go.

Forensic Analysis

A forensic analysis checklist provides common commands to use when analyzing individual systems to determine what happened, and should also indicate the most likely places to look for peculiar behavior. These lists should be customized depending on the operating system, as well as on a given system’s function, i.e., file server, database, web server, domain controller, DNS, etc. They should help responders identify what type of security incident has happened by gathering evidence from log files, intrusion detection systems and other sources, and prompt them to move forward through a specific process for containment and eradication of the issue.

Emergency Contact Communications

A detailed communication plan will ensure that the entire incident response team knows whom to contact, when it is appropriate to contact them, and for what purposes. This checklist should also include what information to convey to those people, based on the specific information that they are likely to need. In addition, it should help them identify the employees who can help get critical systems back online, if needed. Organizations should be sure to get overall consensus on their communications plan, since this is the most important element of a fast and effective response.

System Backup and Recovery

Every system should have its own checklist of tasks — based on its distinct configurations and operating systems — that can help responders confirm when it is no longer compromised and can return to normal operation. It’s important to document in this list the time it will take for each step required to restore operations, and also to test and document, in advance, the full system backup and full system recovery processes.

The ‘Jump Bag’

The SANS Institute, a leading source of information for incident responders, recommends that each team member keep a “jump bag” of important tools on hand. In the event of a security incident, this will enable them to initiate a “grab-and-go” response at any time. This checklist should contain all the tools needed for rapid response, including USB drives, up-to-date anti-malware applications, Forensic Toolkits (FTK) or software like EnCase, network cables, hard drive duplicators and more. One of the most important tools to keep in this bag is an incident handler’s journal, which should be used to document the who, what, where, when and why of an incident.

Post-Incident Security Policy Review

In order to prevent similar incidents from happening in the future, this checklist should cover when and how the problem was first detected, the scope of the incident, how it was contained, which controls failed, and finally, the steps that will be necessary to prevent future incidents. It should also prompt responders to make notes about which elements of the response were particularly effective. This information can be used to update security awareness programs as necessary, since many incidents result from a lack of user education around basic security best practices. This stage is all about learning from our failures and using these lessons to become better prepared for tomorrow.

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Who’s next? 3 tips for implementing a successful succession plan

October 17, 2016
[This was written for the Radiology Department, but the parallels to the needs of an HTM department are obvious.  There are some lessons to be learned in this article.  Pat Lynch]
Oct 06, 2016 | Michael Walter
Leadership is crucial in modern radiology, whether at a private practice, an academic practice or a hospital’s radiology department. But when a group’s leader leaves, who takes their place? Is a qualified candidate available and ready to step in?

Radiology groups must develop a thorough succession plan to ensure a smooth transition from one leader to the next, according to a recent analysis published in the Journal of the American College of Radiology.

Lead author E. Michael Donner III, MD, Radiology Specialists of the Northwest in Portland, Oregon, and colleagues explained that leadership among radiologists often defaults to “those willing to do it,” but choosing the right leader for the job is too important to be taken lightly.

“When effective leadership is absent, radiology groups are vulnerable to significant exposure: loss of revenue through lack of financial oversight, loss of patient volumes through lack of business development and potential replacement through lack of presence and lack of alignment with hospital systems and healthcare plans,” the authors wrote. “As in other businesses, the leadership of radiology groups plays a major role in their success.”

These are three helpful tips provided by Donner et al. for implementing a successful succession plan:

1. Promote from within

When possible, leaders should come from within an organization. Even if a future leader isn’t absolutely perfect, Donner and colleagues said, if they show potential and are open to improving themselves, they should at least be considered for the job.

“The only way to have a robust and reliable succession plan is to map succession to the available internal talent, identify the deficiencies in these individuals, and design and implement development plans to overcome the identified deficiencies,” the authors wrote. “Successful succession planning, therefore, should be a program of internal talent identification, followed by development and management of selected individuals for each designated area of responsibility.”

Mentoring and coaching are both crucial parts of any effective succession plan. Mentoring, the authors explain, includes one-on-one meetings between the potential leader and the individual currently holding that position. Coaching is similar, yet different; it occurs between the potential leder and outside consultants.

2. Succession planning never stops

Radiology groups can’t develop their succession plan and then move on to other issues; doing so would kill momentum and defeat the whole purpose of planning to begin with.

“Succession planning is not episodic but is a continuous process that consists not only of talent recognition but also succession management, which includes talent development and retention of high-potential individuals within the organization,” the authors wrote.

3. Education resources for potential leaders are available

Conner and colleagues listed some of the options potential leaders have to improve their leadership abilities in preparation for one day taking on such a responsibility.

College MBA and executive MBA programs are one option, they said, and the American College of Radiology’s Radiology Leadership Institute is another valuable resource.

“In addition, professional societies such as the RSNA, the ACR, the ARRS, and the Radiology Business Managers Association offer a variety of business courses,” the authors wrote.

Two providers forced to pay up in ransomware attacks

October 14, 2016
New Jersey Spine Center was attacked by Cryptowall, which locked up its EHR, backups and phone system. Marin Healthcare District in California lost two weeks of backup data during restoration.
By Jessica Davis

 Two more ransomware attacks have been reported recently: Marin Healthcare District in Greenbrae, California and the New Jersey Spine Center in Chatham, N.J. Both organizations paid the ransom.

The attack on MHD stemmed from a ransomware attack on Marin Medical Practices Concepts, the health system’s medical billing and electronic medical record services vendor. The breach occurred on July 26.

MHD reported the attack on September 28, when it notified its 5,000 patients some of their medical data was lost during the attack. According to officials, Marin providers were unable to access patient data for more than a week. The computer systems are back online, but the provider lost two weeks of backup data.

A third-party forensic investigation determined there was no evidence patient data, including financial and health information was accessed. However, officials said due to a failure in MMPC’s backup systems during restoration, patient data collected at MHD’s nine medical centers between July 11-26 was lost. Diagnostic test results weren’t lost, and patients don’t need to be re-tested.

MMPC’s CEO Lynn Mitchell told the Marin Independent Journal that the ransom was paid, but said the amount will not be disclosed.

Meanwhile, the six sites of the New Jersey Spine Center were attacked by Cryptowall ransomware on July 27, 2016. It encrypted not only the electronic health record, but also the backup files and phone system. According to officials, the antivirus software detected the virus only after the ransomware was installed.

Hackers likely gained access through a list of stolen passwords run by an automated program. As the organization’s backup files were inaccessible and there’s currently no decryptor for this ransomware variant, officials said there was no alternative but to pay the cybercriminals. The amount paid wasn’t disclosed.

Some 28,000 patients were affected by the breach, according to the breach report sent to the Department of Health and Human Services’ Office for Civil Rights. The FBI and local authorities were also notified of the breach.

Officials said there is no evidence that suggests patient data like Social Security numbers, credit card data and medical history was stolen, but there’s no way to rule out unauthorized access. The organization is offering patients one year of free credit monitoring.

Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com

FDA Seeks Consumer, Patient Perspectives for Advisory Committees

October 13, 2016

Posted October 11, 2016
The Food and Drug Administration (FDA) is looking for new consumer representatives to join a number of its advisory committees, including several that deal with medical devices. The agency is also accepting nominations for the Center for Devices and Radiological Health’s (CDRH) Patient Engagement Advisory Committee.

Consumer Representatives
A consumer representative serves as a liaison between an advisory committee and interested consumers, associations, coalitions, and consumer organizations, as well as participates in committee discussions about the scientific issues that affect consumers.

“We are looking for applicants with knowledge and expertise in all medical fields as well as an affiliation with a consumer organization or an association with consumer interests,” the FDA said in an email announcement.

Positions are available with the following groups:

Allergenic Products Advisory Committee
Anesthesiology and Respiratory Therapy Devices Panel
Blood Products Advisory Committee
Ear, Nose and Throat Devices Panel
Gastroenterology and Urology Devices Panel
Gastrointestinal Drugs Advisory Committee
Immunology Devices Panel
Medical Imaging Advisory Committee
National Mammography Advisory Committee
Peripheral and Central Nervous System Advisory Committee
Science Advisory Board National Center for Toxicological Research
Vaccines and Related Biological Products Advisory Committee
The agency is accepting nominations, as well as applications from interested individuals, until Jan. 31. For more information or to submit an application, please visit the FDA’s consumer representative website.

Patient Engagement Advisory Committee
In a separate announcement, the FDA called for nominees to join CDRH’s Patient Engagement Advisory Committee. Members of this group will help integrate the perspective of patients into the regulatory process for medical devices by discussing the benefits, risks, and clinical outcomes of healthcare technology.

According to the FDA, candidates should be “knowledgeable in areas such as clinical research, primary care patient experience, [or] healthcare needs of patient groups in the United States, or…experienced in the work of patient and health professional organizations, methodologies for eliciting patient preferences, and strategies for communicating benefits, risks, and clinical outcomes to patients and research participants.”

Nominations, including self-nominations, can be submitted using the FDA Advisory Committee Membership Nomination Portal. Nominations received by Nov. 21 will be given first consideration.