Wednesday, September 30, 2020

COVID-19: Saliva Tests Could Detect Silent Carriers

 



One of the biggest problems we've had dealing with the Covid-19 pandemic is the testing.  First it seemed we simply didn't have *enough* tests.  Then it became an issue of finding locations that had the tests and could provide the personnel and the time to do them.  Then you have to factor in actually running and getting the accurate result.

It would be SO much easier if there was a way for the individual who needs a test to do some type of home test.  That would eliminate many of the obstacles that the public has faced in all of this.  With that in mind, I was excited when I came across the following article that comes from Hokkaido University.  



Testing self-collected saliva samples could offer an easy and effective mass testing approach for detecting asymptomatic COVID-19.

Scientists at Hokkaido University and colleagues in Japan have demonstrated a quick and effective mass testing approach using saliva samples to detect individuals who have been infected with COVID-19 but are still not showing symptoms. Their findings were published in the journal Clinical Infectious Diseases.

"Rapid detection of asymptomatic infected individuals will be critical for preventing COVID-19 outbreaks within communities and hospitals," says Hokkaido University researcher Takanori Teshima, who led the study.

Many of the world's governments are showing reluctance to re-institute full national lockdowns as second waves of COVID-19 infections loom on the horizon. Testing and tracing systems will need to be ramped up in order to detect and isolate people who have the virus as early as possible.

Teshima and colleagues tested and compared the nasopharyngeal swabs and saliva samples of almost 2,000 people in Japan who did not have COVID-19 symptoms. Two different virus amplification tests were performed on most of the samples: the PCR test, which is now well-known and widely available around the world, and the less commonly used but faster and more portable RT-LAMP test.

The number of positive and negative results in all samples was very similar, with the nasopharyngeal swabs and saliva samples able to detect those with the infection in 77-93% and 83-97% of subjects, respectively. Both two tests were also able to identify those without the infection in greater than 99.9% of subjects. The virus loads detected in nasopharyngeal swab and saliva were equivalent and highly correlated. Teshima says, "PCR sensitivity is much higher than previously thought 70% that came from initial data of symptomatic patients."

While finding both nasopharyngeal and saliva samples have high sensitivity and specificity to the SARS-CoV-2, Teshima says "Saliva testing has significant logistic advantages over the commonly used nasopharyngeal swab testing." "Self-collection of saliva is painless for examinees, and more importantly, it eliminates the close contact with the examiners, reducing the risk of viral exposure."

"We also found that it is unlikely that the sensitivity of RT-LAMP is significantly less than that of the PCR test, suggesting that it might be a useful alternative for diagnosing COVID-19 infection, especially where diagnosis is required at the point of sample collection, like in sports venues or at airports," says Teshima.

Researchers point to a limitation of the study that they did not follow up with clinical outcomes. Nonetheless, they suggest that the results give good indication that mass screening using self-collected saliva and rapid RT-LAMP testing could provide easy, non-invasive, quick and relatively accurate results, with minimal risk of viral transmission to healthcare workers.

Tuesday, September 29, 2020

The Problem with IoT Devices and the Security Lapses They Create

 

 

 

 

Today's post is a bit geekier than most, but I've got a purpose here.  As Technology Evangelist it's my job to sometimes bring geekier things to light.  So today you get a post about IoT which is short for Internet of Things.  IoT devices are everywhere now.  If you have an Amazon Echo appliance, it's IoT.  A Google Home device?  IoT.  An Internet enabled thermostat?  IoT.  I figure that you're starting to get it now.

The problem that we are starting to see and will continue to see with IoT is that they tend to have little, or even worse, NO security.  Basically people and companies are plugging all of these little devices into their networks and they are doing so with the somewhat blind confidence that the companies that make them are building in strong security.  However, those devices have minimal security and what little exists can be easily hacked and/or bypassed.

There is growing concern that these devices can be used in nefarious ways or "bricked" which means they can basically be rendered useless by destroying the device's operating system resulting in a totally non-functional device.

Recently a researcher took the time to actually hack a smart coffee machine.  The device could be made to spray hot water, turn on the burner, and cause the grinder to spin constantly.  It was also turned into a device that demanded a ransom to be repaired.

As consumers we need to get smarter about what we expect from our devices and we also need to be more demanding about the security aspect of the things we buy.

As healthcare providers we are expected to keep our patient's data safe and this can mean that we don't want to be plugging devices into our networks without understanding the impact they might have.

I also think as dental professionals we need to demand strict security protocols from the devices we use daily in the practice of dentistry.  If you are a digital impression user imagine the impact it would have on your workflow if suddenly your 3Shape Trios shut down or demanded a ransom to continue to work.  As a profession, we've managed to avoid something like that, but we've also managed to avoid other problems.  That doesn't mean they *won't* happen.  It just means that they *haven't* happened... yet.

There is a good article on Gizmodo about this coffee maker hack with several links to other articles.  If you have an interest, give it a read.  

Monday, September 28, 2020

Dental Visits Continue to be Safe and are an Essential Part of a Plan to Improve Overall Health

 




I've said it many times before, but I'll say it here again because no matter how you slice it, the statement is true...  "Fear Sells".  It's an unfortunate part of the way humans are wired intellectually, but it's true.  Terrifying stories and terrifying rumors spread *much* faster than stories of victory, triumph, or success.  Why is that?  No one seems to know for sure.   Psychologists have been studying the phenomenon for years, but haven't come up with much definitive science.

Along those lines, dentistry frequently falls into this category.  Many people have a fear of dentistry anyway, so it's pretty easy to prey on those fears with stories that trigger fright.  Since SARS-CoV-2 reach the United States this winter, dentistry has been front and center on the fight to prevent its spread and also the recipient of lots of speculation on the safety of dental visits.  If you are looking for ways to trigger deep rooted fears in people there are many better ways than trying to pair dentistry with a virus that no one seems to know a lot about and in some cases can be fatal.  Let the speculation begin!

Well the speculation began, but truth beats fiction.  Dentistry is incredibly safe.  Always has been and will continue to be.  At this point in the pandemic there is NO documented case of transmission in a dental setting and that includes during the early phases in China where no one even knew what was causing the respiratory impairment.

Recently Insider.com published an article that goes over the "whys" of safety.  If you are harboring *any* concerns at all, this is a must read.  Of course, even if you have no concerns, I still think you should read it.  There is some great information here.


Some people might be hesitant to visit the dentist during the coronavirus pandemic, especially after the World Health Organization suggested not to in an August announcement.

However, it's actually a low-risk activity for the patient, said Amesh Adalja, an infectious disease expert at the Johns Hopkins University Center for Health Security. 

"I would be more worried about my dentist than I would myself contracting the virus there," Adalja told Insider.

Dentists aren't too concerned either. After the WHO's recommendation to delay routine dental care in certain situations due to COVID-19, the American Dental Association released a statement saying it "respectfully yet strongly disagrees."

"Our first job is to be sure that our patients are safe," American Dental Association President Chad Gehani, DDS, told Insider. "If we did not think that the patients were safe, we simply would not go to the office at all. We would not have even done the emergency care in the months of March, April, and May."

Since mid-May, most dental offices in the US have been open for routine care. During those four months, there has been no evidence of COVID-19 transmission in dental offices, Kami Hoss, DDS, said — "a remarkable track record."

Along with implementing new screening procedures, dentists have taken steps to clear out their waiting rooms, reduce the potential aerosols created by some dental procedures, and ramp up personal protective equipment worn by dental professionals since reopening.

Dentists treat every patient like they could have every infectious disease

Dentists have been dealing with the possibility of coming into contact with infectious diseases from HIV to hepatitis since well before the coronavirus pandemic.

"As a profession, we are infection control experts," Hoss said. "We've always had to deal with infectious diseases and diseases that are easily transmitted via air or through blood." 

It's already standard practice for dentists and hygienists to wear masks and gloves to decrease their risk of transmitting or contracting diseases, and they've only stepped up their PPE since the pandemic, Hoss said.

The ADA also recommends additional precautions to reduce the creation of aerosols, which can carry viral particles through the air. Those measures include using high-powered suction whenever possible, and, for longer procedures, limiting exposure with rubber dental dams.

You won't find magazines in waiting rooms anytime soon

Back when dental offices in the US closed to non-emergency care in March, the primary concern was transmission in crowded waiting rooms, not during dentist-patient interactions, Gehani said.

The ADA has since encouraged dentists to limit the amount of people that pass through their offices and take away some of the shared objects they might touch. At Gehani's practice in New York, a waiting room that could hold 14 people now seats four — and there are no magazines in sight.

Hoss said the check-in process that used to take place in his waiting room is now almost entirely virtual. Patients undergo a phone screening before they book an appointment, fill out forms online instead of at reception, and they're screened again and get their temperature checked before they enter the office.

Oral health affects your overall health, so now is not the time to skip your cleaning

Much of dental care is preventive in nature, Hoss said, so it's important to keep up with regular cleanings and not put off filling cavities. Delaying a simple procedure could result in a much more costly, involved operation down the line.

Poor oral hygiene can also have "cascading effects" on other aspects of your health, Adalja said. He said he never advocated for the closure of dental offices during the pandemic because he considers dentistry to be an essential health service.

Studies have shown gum disease is associated with a higher risk of dementia, heart disease, and rheumatoid arthritis, among other health issues. And according to a pre-print of a study due to be published in the Journal of the California Dental Association next month, COVID-19 patients with gum disease have a higher risk of developing acute respiratory complications and dying.

"During a pandemic, one of the best things we can do is to stay healthy, and staying healthy starts with our oral health," Hoss said.

Thursday, September 24, 2020

Nobio’s Antibacterial Composites Receive FDA 510(k) Clearance for Addressing a Key Process in Tooth Decay

 

 

 

 

For over a year now, I've been evaluating and working with the Nobio company out of Israel.  They have developed a product that is nothing less than amazing.  These incredibly smart people have created a molecule that can be added to plastics that gives it incredible antimicrobial activity.  In the simplest explanation, it is a nanoparticle that kills any organism that comes in contact with it.  The company has added this molecule to a composite resin.  Think about that for a moment...  There is now a restorative material that kills bacteria on contact.

Impressive.  This could well be product that changes dentistry as we know it.  Read on for the details released in response to FDA clearance:

 

Clinical data show that Infinix composites significantly reduce tooth demineralization

Kadima, Israel – September 8, 2020 -- Nobio Ltd. today announced it has received an additional FDA 510(k) clearance for the company’s Infinix™ family of dental composites. Clinical data supporting the company’s submission to the FDA demonstrated that Nobio Infinix antibacterial composites significantly reduce tooth demineralization, which is part of the caries-formation (tooth decay) process.

 

“The data further validates our technology which promises a breakthrough in restorative dentistry improving outcomes for dentists and their patients” said Yoram Ashery, Nobio CEO. Nobio’s Infinix composites incorporate its patented QASi™ particle technology, which has shown long lasting inhibition of bacterial growth at the margins of composite fillings. “Infinix gives dentists a new tool to fight recurrent caries which is the main cause of restoration failure” said Ashery.

 

Tooth decay is a process, where bacteria generate acids that dissolve teeth by causing demineralization (tooth mineral loss), which leads to cavitated lesions (caries). Recurrent caries, tooth decay that occurs under existing fillings, crowns, or onlays, is a major cause of premature restoration failure.

A clinical study was performed at the University of California, San Francisco (UCSF) to assess Infinix’ s antibacterial activity in slowing and reducing demineralization. This study, completed in March, was led by principal investigator Peter Rechmann, DMD, PhD, professor and director of the Clinical Sciences Research Group at the UCSF School of Dentistry, and President of the American Academy of Cariology. “Our study showed that mineral loss in teeth adjacent to Infinix composites was two-thirds less than for the standard composite material, indicating the potential for less recurrent decay, longer-lasting restorations and less natural tooth loss”, said Dr. Rechmann.

Prof. Ervin Weiss, DMD, Nobio’s CTO and co-founder, and Dean Emeritus of the School of Dentistry of Tel-Aviv University, added, “We believe Infinix is a major advancement for dentistry that will reduce the likelihood of restoration failures due to secondary caries with its associated discomfort and costs.”

Nobio plans to initiate commercial sales of its Infinix product line by the end of this year. Dentists interested in trying Infinix composites can reserve a free Starter Kit at www.Infinix.com. 

 

 

 

Wednesday, September 23, 2020

Henry Schein Offers Free IT Network Assessment




As regular readers know, I am a huge advocate of data security.  I've lost count of the number of times I've posted the "Biohazard" image that associate with my posts on all things security.

Hackers and the criminal computer groups out there have reached new levels of activity and no one is immune.  These folks are smart, driven, and relentless.  Simply resting on your laurels and figuring that "It won't happen to me" is simply an invitation to suffer data theft, ransomware, or worse.  As I've said here many times, you need to be prepared.

To that end, the folks at Henry Schein are offering Free Network Assessments to help you be more secure.

Here is the info complete with a link to request the assessment:


A malware attack could be devastating to your practice. Are you prepared?

Did you know that over 31 million patient records were breached from healthcare organizations in the first half of 2019? When it comes to cyberattacks, healthcare remains a favorite target of hackers.

 

As a dentist, you need to be careful with your protected health information (PHI), because a malware attack, and ransomware in particular, could be financially devastating to your practice (not to mention the permanent damage it can do to your practice’s reputation).  You need to ensure that you have the network technology and support necessary to protect your practice.

 

To meet this need, TechCentral by Henry Schein One created OmniCore, a comprehensive network security solution for the dental market.

OmniCore is an all-in-one dental network in a box that gives dentists multilayered protection for their data. It includes a virtualized server, business-grade firewall and wireless access point, anti-virus software, data backup both locally and in the cloud, and the remote monitoring and management you need to help prevent the loss of patient data.

 

Sophisticated attacks require sophisticated network security solutions. Request a complimentary IT network assessment today to gain a better understanding of your current IT setup and to learn more about how solutions like OmniCore protect your practice and your data.

Tuesday, September 22, 2020

RansomWare Attack Blamed in Patient's Death in Germany

 




RansomWare attacks continue to escalate.  Unfortunately as that happens, more and more healthcare agencies get in the crosshairs.  I've been saying for a while now that at some point some type of data intrusion would result in a patient death.  Well now it looks like we have one.

Last Thursday in Germany a woman developed a life threatening emergency and called for an ambulance.

The original plan was for the patient to be taken to the University Hospital Duesseldorf, but unfortunately that didn't happen.  The hospital was not accepting emergency patients because 30 of their servers had been encrypted by RansomWare.  The result was that the patient was re-routed to a hospital 20 miles away in Wuppertal.  Unfortunately, in emergency medicine time counts and the delay of her treatment resulted in her death.

Hospitals are dependent on the instantaneous availability of clinical information and when that isn't possible, care suffers and some can suffer greatly.

I have a friend, Brett Callow who works as a threat analyst for Emsisoft, which is a New Zealand security firm.  His take on this?  “This was absolutely inevitable,” said Brett. “We are fortunate it hasn’t happened sooner.”

The story becomes even more strange.  The hospital is part of a university and there is speculation that the RansomWare criminals may actually have been targeting the university itself and that the hospital may have been collateral damage.

It seems that when police in Dusseldorf contacted the attackers through the ransom note and informed them that the university hospital was involved, the criminals gave the encryption key to the police, which allowed for the data to be restored, and then the criminals vanished.

However, despite the fact that they gave the encryption key to the police, doesn't mean these people are all fluffy bunnies and unicorns.  No, they are still criminals.  German prosecutors are now exploring the chance of possible manslaughter charges.  Of course, the chance of finding the perpetrators is slim.

As RansomWare continues to evolve and proliferate, this is bound to get worse.  The only solution I see is stronger crackdowns by the law, but in some rogue states, these cyber criminals actually payoff the government to work with impunity.  Will things change?  Lives hang in the balance,.

Monday, September 21, 2020

Work Begins on CMS Product Review

 



A unique way to battle periodontal disease was presented to me recently and I've decided to do some clinical evaluation of it.  CMS Dental is European company that makes products for endodontics, perio, and curing lights.  They also sell probiotics.

The technique that I'm going to do an evaluation on is called Light Activated Disinfection (LAD).

The process encompasses the following:

  • Thorough scaling and root planing
  • Applying a product called QroxB2 gel into the pocket
  • Use a specially designed light to activate the gel
  • ProlacSan probiotics

The idea is to help change the microflora both in the pocket and in the mouth.  The QroxB2 gel being activated by the light kills the bacteria in the periodontal pocket.  The next step is "big picture" by using probiotic lozenges to change the type of bacteria found in the mouth.  The idea is that if the "bad" bugs are removed, good bugs will proliferate.  This means that recurring incidence of periodontal problems should decrease because the bacteria that cause problems are present in much smaller numbers than before.

The probiotic is designed to increase competition between bacterial strains in the oral cavity.  The probiotic feeds the "good bacteria" which are in competition with the "bad bacteria"  By allowing the growth of "good" we should see a decrease of "bad".

I'm interested to see how this treatment works in clinical practice.  Since it is a perio product, it may take me a few months to be able to evaluate how successful this is.  However, I'm optimistic about the product.  I'll keep you informed.

Thursday, September 17, 2020

MEDITECH Launches Expanse Virtual Assistant through Strategic Conversational AI Collaboration with Nuance

 



It's starting to look like the promise of the past is starting to take shape in the now.  In the very early 2000s many of us who were pushing for tech expansion into the healthcare sector were dreaming dreams of efficiency brought on by powerful graphic user interfaces combined with powerful processors.  For those of you who have been around for a while, you probably remember the tech trade show Comdex that was help every fall in Las Vegas (it's now been supplanted by CES).  One year, during its peak time, Comdex was displaying several voice dictation systems that a lot of us were hoping would make the keyboard a bit of a "not so needed" accessory in the near future.

Unfortunately that plan didn't work out like I had hoped it would.  For many reasons, voice dictation didn't take off the way I had hoped.  Then around the time of the iPhone 4 we began to hear more about Siri and then voice just "exploded" onto the scene.  Now we are using it for all kinds of things.

Now comes word of a leap forward in EHR use which sounds pretty exciting.  The only concern that i would have on this is HIPAA security.  The user would need to make sure they cannot be overheard.  Here is the info:


BURLINGTON, Mass. & WESTWOOD, Mass.--()--MEDITECH and Nuance Communications Inc. (Nuance®) are re-imagining the way physicians interact with their Expanse EHR by introducing intuitive voice-driven navigation. Built upon the leading Nuance Dragon® Medical solution already used by more than 550,000 physicians, the companies have partnered to launch the MEDITECH Expanse Virtual Assistant. Nuance’s deeply embedded virtual assistant technology and sophisticated conversational AI dialogue and skills will enable physicians to navigate their EHR hands-free and transform the way they practice and provide care. By simplifying routine tasks, physicians can save steps and time, freeing them up to focus on direct patient care.

“MEDITECH continues to drive the industry forward by providing solutions that improve efficiency and reshape the patient experience,” said MEDITECH Executive Vice President Helen Waters. “In partnership with Nuance, Virtual Assistant technology represents another leap forward in usability and efficiency, ushering in a new era of digital transformation. Physicians can simply ask for what they need from their Expanse EHR and get it.”

Using simple voice commands, physicians can leverage Expanse Virtual Assistant to navigate and search patient charts for key areas of information including lab results, medications, allergies, radiology images, and more. Users can simply ask ‘Ok, MEDITECH, when was the last EKG?’ It is a powerful tool that allows physicians to directly engage with their patients and quickly access and review key EHR data and images together.

The COVID-19 pandemic has furthered the demand for touchless technology as healthcare providers are asked to limit the physical touching of objects such as keyboards, phones, and screens. But this benefit extends well beyond the current pandemic. For example, in surgical settings, physicians can use the Expanse Virtual Assistant to access information without having to leave the sterile field in the operating room.

“Conversational AI is essential for eliminating the barriers to positive physician-patient interactions, reducing administrative burdens on clinicians and empowering providers to keep patients and successful healthcare outcomes their priority,” said Peter Durlach, Senior Vice President of Strategy and New Business Development, Nuance Healthcare. “We are very excited to expand our decades long strategic partnership with MEDITECH and deliver this cutting-edge technology to Expanse. Our shared goal is to improve efficiency and increase clinician satisfaction for those who take care of all of us, and enhance the overall provider-patient experience.”

To learn more about the MEDITECH Expanse Virtual Assistant, click here.

Wednesday, September 16, 2020

IBM Study Finds that Data Breaches in Healthcare are the Most Expensive

 


Data breaches are expensive.  There is no way around that fact.  They are labor intensive and sometimes can even include upgrading and/or replacing hardware that is either outdated or crippled by an attack.  No matter what sector of business you are in, Ransomware or a breach that results in theft of data is expensive to weather and expensive to cleanup.

However, the Healthcare sector has some unique aspects to it that can make data breaches even more expensive and some of those have to do with fines issued by government agencies.  Federal mandates such as HIPAA or other regulations from state or even local governments can increase the cost of a data breach astronomically for the entity involved.  

The recent release of IBM's annual Cost of a Data Breach report shows that the average business encounters costs of about $3.86 million for a data breach while a healthcare entity averages $7.13 million in expenditures.  This obviously is no small amount and the difference of $3.27 million between the two average expenditure amounts shows how financially dangerous a breach can be for a company in healthcare.

Now, some of the reasons for the greater costs are because governmental bodies feel the need to make companies understand how important it is to protect PHI (Protected Health Information).  That's because there is SO much valuable data inside of a person's health record.  practically every piece of demographic information is there.  Social Security Numbers, address, birth date, spouse, phone number, etc.  Stealing that information makes it very easy for criminals to fabricate new identities and use them to acquire goods, loans, you name it.  The value of a health record can easily be $50 each on the dark web.  That compares to single digits for verified credit cards.  So governments see a need to force healthcare companies to protect that data... and rightfully so.


Here is what some of the report has to say.  For the full report, follow this link.  


IBM (NYSE: IBM) Security today announced the results of its annual study examining the financial impact of data breaches on organizations. According to the report, the cost of a data breach has risen 12% over the past 5 years1 and now costs $3.92 million on average. These rising expenses are representative of the multiyear financial impact of breaches, increased regulation and the complex process of resolving criminal attacks.2

The financial consequences of a data breach can be particularly acute for small and midsize businesses. In the study, companies with less than 500 employees suffered losses of more than $2.5 million on average – a potentially crippling amount for small businesses, which typically earn $50 million or less in annual revenue.

For the first time this year, the report also examined the longtail financial impact of a data breach, finding that the effects of a data breach are felt for years. While an average of 67% of data breach costs were realized within the first year after a breach, 22% accrued in the second year and another 11% accumulated more than two years after a breach. The longtail costs were higher in the second and third years for organizations in highly-regulated environments, such as healthcare, financial services, energy and pharmaceuticals.

"Cybercrime represents big money for cybercriminals, and unfortunately that equates to significant losses for businesses," said Wendi Whitmore, Global Lead for IBM X-Force Incident Response and Intelligence Services. "With organizations facing the loss or theft of over 11.7 billion records in the past 3 years alone, companies need to be aware of the full financial impact that a data breach can have on their bottom line –and focus on how they can reduce these costs."

Sponsored by IBM Security and conducted by the Ponemon Institute, the annual Cost of a Data Breach Report is based on in-depth interviews with more than 500 companies around the world that suffered a breach over the past year.3 The analysis takes into account hundreds of cost factors including legal, regulatory and technical activities to loss of brand equity, customers, and employee productivity. Some of the top findings from this year's report include:

  • Malicious Breaches – Most Common, Most Expensive: Over 50% of data breaches in the study resulted from malicious cyberattacks and cost companies $1 million more on average than those originating from accidental causes.
  • "Mega Breaches" Lead to Mega Losses: While less common, breaches of more than 1 million records cost companies a projected $42 million in losses; and those of 50 million records are projected to cost companies $388 million.4
  • Practice Makes Perfect: Companies with an incident response team that also extensively tested their incident response plan experienced $1.23 million less in data breach costs on average than those that had neither measure in place.
  • U.S. Breaches Cost Double: The average cost of a breach in the U.S. is $8.19 million, more than double the worldwide average.
  • Healthcare Breaches Cost the Most: For the 9th year in a row, healthcare organizations had the highest cost of a breach – nearly $6.5 million on average (over 60% more than other industries in the study).

Malicious Breaches Pose a Growing Threat; Accidental Breaches Still Common
The study found that data breaches which originated from a malicious cyberattack were not only the most common root cause of a breach, but also the most expensive.

Malicious data breaches cost companies in the study $4.45 million on average  over $1 million more than those originating from accidental causes such as system glitch and human error. These breaches are a growing threat, as the percentage of malicious or criminal attacks as the root cause of data breaches in the report crept up from 42% to 51% over the past six years of the study (a 21% increase).

That said, inadvertent breaches from human error and system glitches were still the cause for nearly half (49%) of the data breaches in the report, costing companies $3.50 and $3.24 million respectively. These breaches from human and machine error represent an opportunity for improvement, which can be addressed through security awareness training for staff, technology investments, and testing services to identify accidental breaches early on. One particular area of concern is the misconfiguration of cloud servers, which contributed to the exposure of 990 million records in 2018, representing 43% of all lost records for the year according to the IBM X-Force Threat Intelligence Index5.

Breach Response Remains Biggest Cost Saver
For the past 14 years, the Ponemon Institute has examined factors that increase or reduce the cost of a breach and has found that the speed and efficiency at which a company responds to a breach has a significant impact on the overall cost.

This year's report found that the average lifecycle of a breach was 279 days with companies taking 206 days to first identify a breach after it occurs and an additional 73 days to contain the breach. However, companies in the study who were able to detect and contain a breach in less than 200 days spent $1.2 million less on the total cost of a breach.

A focus on incident response can help reduce the time it takes companies to respond, and the study found that these measures also had a direct correlation with overall costs. Having an incident response team in place and extensive testing of incident response plans were two of the top three greatest cost saving factors examined in the study. Companies that had both of these measures in place had $1.23 million less total costs for a data breach on average than those that had neither measure in place ($3.51 million vs. $4.74 million).

Additional factors impacting the cost of a breach for companies in the study included:

  • Number of compromised records: Data breaches cost companies around $150 per record that was lost or stolen.
  • Companies that fully deployed security automation technologies experienced around half the cost of a breach ($2.65 million average) compared to those that did not have these technologies deployed ($5.16 million average).
  • Extensive use of encryption was also a top cost saving factor, reducing the total cost of a breach by $360,000.
  • Breaches originating from a third party – such as a partner or supplier – cost companies $370,000 more than average, emphasizing the need for companies to closely vet the security of the companies they do business with, align security standards, and actively monitor third-party access.

Regional and Industry Trends
The study also examined the cost of data breaches in different industries and regions, finding that data breaches in the U.S. are vastly more expensive – costing $8.19 million, or more than double the average for worldwide companies in the study. Costs for data breaches in the U.S. increased by 130% over the past 14 years of the study; up from $3.54 million in the 2006 study.

Additionally, organizations in the Middle East reported the highest average number of breached records with nearly 40,000 breached records per incident (compared to global average of around 25,500.)

For the 9th year in a row, healthcare organizations in the study had the highest costs associated with data breaches. The average cost of a breach in the healthcare industry was nearly $6.5 million - over 60% higher than the cross-industry average.

Tuesday, September 15, 2020

Outside-the-Box Sterilization Monitoring

 





In the midst of stricter infection control protocols, autoclave monitoring is often overlooked. The TerraGene MiniBio and the 3M Attest can change that.

We’ve seen a lot of changes in the past 6 months. In some ways, it seems time truly flies, but with the next breath, you can hear yourself thinking, “Wait, that ‘just’ happened?”

This is a really strange time to be alive. In the short span of 6 months, we have seen our lives and our practices practically turned inside out. So many things have changed that I sometimes feel it’s almost too much to process.

A true story here: Last week, I met an acquaintance whom I had not seen since before the entire coronavirus disease 2019 (COVID-19) catastrophe. He’s a gregarious “big” personality who just lights up any room he enters. He walked up to me and stuck out his hand. There was a brief moment where I just locked up, unsure of what to do. Then, I figured, “This is why we have hand sanitizer,” and I shook his hand. For those of you who know me, I’m a touchy-feely type, a hugger—but I hadn’t shaken a hand in more than 6 months. It felt creepy—the same kind of creepy I’d probably feel if I reached into a mouth without wearing gloves. Until I got back to my hand sanitizer, I was almost painfully aware of my right hand and what might be on it. I sure as heck didn’t get it near my face! As soon as I could, I slathered on hand sanitizer and then sat back to ponder how different this was from just March of this year.

For more than 30 years, dentistry has had an amazing infection control protocol. We have always been on the forefront of keeping our patients and our teams safe. And we ought to be doing these things. I would venture to guess that we probably perform more outpatient services that generate aerosols than any other profession in health care.

I am very proud of what we have done in response to the COVID-19 pandemic. Dentistry has taken huge steps in the last few months to ensure the safety of those we treat and those we employ. Just even walking into most offices now looks totally different than it did 6 months ago and that’s before you take into consideration the clinical changes we have implemented.

As Technology Evangelist, I’m always on the hunt for better, more efficient, and cost-effective ways to provide better outcomes for our patients and for our practices. One phrase never fails to elevate my blood pressure: “But we’ve always done it that way.” I’m a firm believer that better ways to do things are always waiting just over the horizon. All we have to do is find them.

In the situation we currently face, a great deal of time and treasure has been put toward our protocols for infection control. Our profession has implemented massive changes in our infection control processes and systems, many of which are devoted to decreasing the odds of cross-contamination.

I’d like to discuss, though, a part of the system many of us probably haven’t looked at closely in quite some time: monitoring our autoclaves. I think this is because autoclave use often happens where and when the doctor doesn’t really see the process, and it has become just another standard task that is usually done by a delegated dental assistant.

Currently, most offices are utilizing some type of “sterilization monitoring service.” Such a service works like this:

The monitoring company sells the office a supply of spore test strips. Of each set of 2, one strip is placed into the autoclave and processed in a normal sterilization cycle, while the other strip is not run and is used as the control. Upon completion of the sterilization cycle, the strip is removed from the autoclave and then both strips, properly identified as test and control, are sent to the testing facility.

Once the strips arrive there, both are placed in an environment where the spores they contain can be grown and are monitored. If the control strip shows growth and the test strip does not, the test is considered successful and all is well. However, if both show negative growth or, even worse, both show positive growth, the test is considered a fail.

With a failed test, the dental office must be notified right away. Once notification is received, the autoclave is immediately taken out of service. A second test is run. If this test shows success, the previous test is considered an aberration and all is well. However, if a second failure occurs, something is seriously wrong with the autoclave and it requires service by qualified personnel.

This testing system works, but the real problem is the amount of time involved. If the test results are sent by mail, several days can pass between a failed test and the office’s receipt of the notification. Also, if a second test is required, at least the same amount of time is “downtime” for the autoclave until a “pass” is received back.

Now what if there was a way for the office to know the results of these tests in less than half an hour? Would you be interested? I thought you would.

Two systems—the TerraGene MiniBio and the 3M Attest—have come to market and can do just that. These systems consist of an incubator and test-tube–like devices filled with spores and growing medium that are referred to as biologic indicators (BIs). I’ve been putting both systems through some clinical trials in my practice for well over a month.

In a manner similar to the spore strip test described above, an office takes one BI and marks it as “test” and another from the same box marked as “control.” The test BI is run in a normal cycle. After the cycle, the tube should cool for 10 minutes. Then (in both brands) you break the seals on 2 tubes that mix any spores that are present with a growth medium. Next, you place both tubes, containing the control and test strips, into the incubator. The incubator then warms the BIs and monitors the tubes for fluorescence, which indicates spore growth.

If the incubator detects growth, a fairly loud beeping alarm sounds and the well that contains the failed tube is identified. On the 3M Attest, the failure is shown by a lit-up “+” sign; on the TerraGene, it’s denoted by a red LED light.

Because there is always 1 tube (the control) that will test positive, the alarm will always go off. I think this is a good feature because it lets the user know the system is indeed working.

The TerraGene MiniBio has 3 wells, so it can test 2 autoclaves and the control simultaneously. Positive and negative results are indicated by green and red LEDs, and the device also contains a tiny printer. All results are printed on a thin strip of paper that can be saved for record-keeping purposes. The device definitely has a remarkable high-tech look, and even better, it runs the test cycle in an impressive 20 minutes.

The 3M Attest has 4 wells but lacks a printer. The LED indicators are built into the device’s side. In addition to “+” and “–” for pass and fail, these LEDs also show the time left in the test. This device runs a test in 24 minutes (versus the MiniBio’s 20), so you’ll see “24…23…22…” etc, to indicate the time remaining. 3M definitely went for a ‘less is more’ esthetic with this device.

Each device also has a USB connection that allows results to be downloaded to a computer that runs software created by each company. The office can then digitally monitor and record results for safe, effective long-term record-keeping.

As for costs—which we must consider—I find both of these products to be incredibly affordable for the peace of mind they deliver. My best current information is that each incubator sells for around $600. The BI tubes cost around $4 each for the MiniBio and $5 for the Attest.

The biggest plus is the speed at which you get the results. Gone is the era of waiting days for them. Now, you can run a test quickly and extremely accurately in your office, anytime you would like, and have those results in less than half an hour. Again, I’ve been using both devices for more than a month and have been very impressed with the performance of both.

In a world where we are trying as hard as possible to ensure the strength of our decontamination, protection, and sterilization processes, in-house monitoring of a critical system such as this is essential. I can’t imagine going back to the “old” way.


Monday, September 14, 2020

DentaQuest Establishes New Fund to Support Patient Safety at New York Dental Clinics During Pandemic



DentaQuest, the nation’s leading purpose-driven oral health organization, today announced a $150,000 contribution to the Community Health Center Association of New York State (CHCANYS) to establish and fund The DentaQuest COVID-19 New York Dental Care Fund, which will provide grants to support patient safety efforts at safety net dental clinics across New York during the pandemic. “These grants will provide some welcome economic relief to safety net dental programs across New York state as people return to get overdue dental care,” said Rose Duhan, President and CEO of CHCANYS. We thank DentaQuest for recognizing and helping to meet these communities’ needs.

DentaQuest also committed $50,000 to NYC Health + Hospitals (NYC H+H) to support the Mayor’s Office of Criminal Justice program that is providing non-congregate housing for inmates released from jail during the pandemic who otherwise would not have a place to live. This donation will provide personal care products, including toothbrushes, floss, toothpaste, soap, shampoo, sunscreen and face masks, to help these individuals as they transition back into community life. A portion of these funds will also support NYC H+H Gotham Health sitesdental programs across the 5 boroughs of New York City.

Finally, DentaQuest contributed $50,000 to acquire a supply of personal hygiene kits that will be distributed to families at community centers, health centers and homeless shelters across New York City.

These commitments follow the company’s recent contribution of $25,000 to support the continued work of Callen Lorde Health Centers during the pandemic and a $145,000 donation by the DentaQuest Partnership for Oral Health Advancement to United Way of New York City’s COVID-19 Community Fund.

In our role providing dental benefits to over 4 million members in New York, we are working with our managed care partners, clients and providers to make oral health care more affordable and easier to access with a focus on prevention,” said DentaQuest President and CEO Steve Pollock. “During the pandemic, we are working hard to ensure a strong and resilient oral health community, and we are proud to lend our support to organizations helping millions of New Yorkers manage through a particularly challenging period.”

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About DentaQuest

DentaQuest is a purpose-driven oral health care company dedicated to improving the oral health of all. We do this through Preventistry® our all-in approach to better care, expanded access, value-based financing, and innovative solutions. We manage dental and vision benefits for 27+ million Americans and provide direct patient care through our network of more than 80 oral health centers in 6 states. We provide outcomes-based, cost-effective dental solutions for Medicaid and CHIP, Medicare Advantage, small and large businesses, and individuals nationwide. And, we've invested more than $200 million in grants and programs to achieve measurably healthier communities across the country. By advancing prevention-focused oral health, we will achieve better overall health for everyone. Learn more at www.DentaQuest.com and follow us on Twitter @DentaQuest, Facebook www.facebook.com/DentaQuest, Instagram @Inside_DentaQuest, and LinkedIn www.linkedin.com/company/DentaQuest. 


Thursday, September 10, 2020

An Open Letter to the Biopharmaceutical Industry


 


In the last week we've begun to hear about the potential for two drugs with the potential to be used as vaccines against Covid-19.  Never before has there appeared to be such a rush to produce a vaccine.  We have seen this race happen at a pace we've never seen before.  In fact, the process has been referred to as "Operation Warp Speed".   Yet, this is not just a race against time, it's a race that must be done properly and with proper safety included.  It normally takes years to bring a vaccine to the market, not months, and the reason for that is all of the safety that factors into a drug like this.

In a situation like this, it is imperative that the safety of the drug be at the top of the list.  A recent letter that has been published by the Biotechnology Innovation Organization pretty much describes this situation in the most succinct terms.  Here is the letter:


The biopharmaceutical industry is at the center of the world’s fight against Covid-19, leading the effort to develop new vaccines, therapeutic medicines and diagnostics. Over time, we expect these efforts to be successful, resulting in a range of new healthcare products for the benefit of the entire world. These new products will need to be manufactured in large quantities and distributed rapidly to all segments of our society. Physicians, public health officials, patients and healthy citizens will need to be educated as to their safety, efficacy, and risk/ benefit. Their widespread adoption will be based on trust in the integrity of the scientific and public health principles governing their development and approval. 


If this is done correctly, we will halt the pandemic, save lives, reignite our economy and enable a return to a more normal life. We will emerge from this pandemic better prepared to address and react to future biological threats. 


As data begin to emerge from clinical trials of an array of vaccines and therapeutics, we believe that it is important for us in the biopharmaceutical industry to articulate the principles we see as essential for assessing these data and determining their potential value. We believe that public health, and the public’s trust in new medical products, are dependent upon the integrity, transparency and objective assessment of new data as they emerge. 


Accordingly, we are articulating the following principles: 

1. Clinical trials should be conducted according to best practices to assure credibility of the data, as well as the ethical participation of a diverse population of subjects. 

2. Companies should disclose important clinical data via well-respected scientific meetings or rigorous, independent peer review journals. The disclosure of key scientific and clinical data through meetings and journals is the gold standard. However, companies may need to release some clinical data in advance of publication. In these instances, companies should approach any pre-publication press activity thoughtfully, and data should not be released by press release alone. Sponsors should ensure that data included in any press statement are clear and include accurate descriptions of key data points while reinforcing that the full data will be submitted for peer review. 

3. FDA should maintain its historic independence as the gold-standard international regulatory body, free from external influence. This will assure the public that the FDA review process will adhere to the highest standards of scientific and medical integrity, and that any approved products therefore will meet the required standards of safety and efficacy.

 4. The appropriate use of any new products should be data-driven. Different sub-populations are likely to react differently to different medicines. These differences will begin to be revealed in larger long-term studies. The public should be assured that only rigorously considered data will dictate the subsequent use of any product. Distribution of any vaccines should be done with these considerations in mind.

5. Political considerations should be put aside by Republicans and Democrats alike. Our nation’s leaders should reassure the public that politics will not influence the development and approval of new medicines. Conclusions about both the safety and effectiveness of such medicines should be based on rigorous collection and assessment of data by all the appropriate bodies, and their distribution should be based on sound public health considerations. This approach is all the more vital considering the unprecedented pace and scale of the effort to develop treatments and vaccines for Covid-19. 


We urge all parties involved in the development, review, approval, and distribution of COVID-19 therapeutics and vaccines to commit themselves to these principles.


Sincerely, 

Jeremy M. Levin, DPhil, MB BChir Chairman of the Board and CEO Ovid Therapeutics Chair, Biotechnology Innovation Organization (BIO) 

Paul J. Hastings President and CEO Nkarta Therapeutics, Inc. Vice Chair, Biotechnology Innovation Organization (BIO) 

Ted W. Love, MD President and CEO Global Blood Therapeutics Chair, Emerging Companies Section Governing Board Biotechnology Innovation Organization (BIO) 

Michelle McMurry-Heath, MD, PhD President and CEO Biotechnology Innovation Organization (BIO) 

Ron Cohen, MD President and CEO Acorda Therapeutics, Inc. Former Chair, Biotechnology Innovation Organization (BIO) 

Rachel K. King Founder and CEO GlycoMimetics, Inc. Former Chair, Biotechnology Innovation Organization (BIO)

 John Maraganore, PhD CEO Alnylam Pharmaceuticals, Inc. Former Chair, Biotechnology Innovation Organization (BIO) 

Richard Pops Chairman & CEO Alkermes, Inc. Former Chair, Biotechnology Innovation Organization (BIO)