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After years of mounting criticism, the federal government is planning to end a controversial program that forces drug makers to win regulatory approval for medicines already on the market that were never actually approved.The Unapproved Drugs Initiative was launched in 2006 to gather data on lasix 40mg tablet price in canada numerous medicines that had been available for years on a grandfathered basis because they predated stricter approval requirements. More recently, the initiative generated complaints that some companies established monopolies after winning regulatory approval for a medicine, which in turn, led to big price hikes or shortages in some cases. Unlock this article by subscribing lasix 40mg tablet price in canada to STAT+ and enjoy your first 30 days free!. GET STARTED Log In | Learn More What is it?. STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life lasix 40mg tablet price in canada science coverage and analysis.

Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What's included?. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like lasix 40mg tablet price in canada our CRISPR Trackr.At the start of a biennial contest to predict the structure of proteins, the expectations for Google’s artificial intelligence unit DeepMind couldn’t have been higher. Think Mike Tyson in the mid-1980s. Everyone was expecting a knockout.The results of the contest, known as CASP, came out Monday — and DeepMind didn’t disappoint, stunning the field by essentially solving one of biology’s most enduring lasix 40mg tablet price in canada challenges.

Quickly and accurately predicting the 3D structure of a protein from its amino acid sequence. The discovery stands to accelerate drug discovery by giving scientists more precise information about how proteins function within cells, allowing them to better target those proteins to counteract the mechanisms underlying disease.Even John Moult, a computational biologist at the University of Maryland who co-founded the contest in 1994, said DeepMind’s performance this year doesn’t leave much left to figure out.advertisement “This is a big deal,” Moult told Nature. €œIn some sense the problem is solved.” In the contest, teams are asked to submit predictions for proteins whose structures have already been solved by other means, such as X-ray lasix 40mg tablet price in canada crystallography, but not publicly disclosed. A team of independent scientists then compares the predictions to the previously determined structure.advertisement DeepMind’s program, called AlphaFold, outperformed its competitors — mostly academic labs — by a wide margin, scoring about 90 out of 100 on protein structures deemed moderately difficult, while most others scored around 75. Nearly two-thirds of its predictions were comparable to structures lasix 40mg tablet price in canada previously determined in the lab.“I’m impressed,” wrote Derek Lowe, a drug discovery columnist for Science Translational Medicine.

€œWe’re not up to ‘guaranteed protein structure for whatever you put it’, but getting that level of structural accuracy on that many varied proteins is something that has just never been done before.”The company’s breakthrough essentially means that it figured out how to use AI to deliver relatively quick answers to questions about protein structure and function that would take many months or years to solve using currently available methods. One researcher who judged the contest, Andrei Lupas, a biologist at the Max Planck Institute for Developmental Biology in Germany, said DeepMind was able to predict the structure of a protein that had confounded his lab for more than a decade. €œThis will change medicine,” lasix 40mg tablet price in canada Lupas told Nature. €œIt will change research. It will lasix 40mg tablet price in canada change bioengineering.

It will change everything.”DeepMind’s AlphaFold research team said in a blog post that it intends to describe its methods in a peer-reviewed journal in the coming months. In the meantime, the team described its performance in CASP as one of the company’s “most significant advances to date,” noting that it could help advance the understanding of hundreds of millions of unmodeled proteins.“For all of us working on computational and machine learning methods in science, systems like AlphaFold demonstrate the stunning potential for AI as a tool to aid fundamental discovery,” the team wrote..

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With new technologies come lasix heart medicine new ethical (and legal) challenges. Often, we can apply previously established principles, even though it may take some time to fully understand the detail of the new technology - or the questions that arise from it. The International Commission on Radiological Protection, for example, was founded in 1928 and has based its advice on balancing the radiation exposure associated with X-rays and CT lasix heart medicine scans with the diagnostic benefits of the new investigations. They have regularly updated their advice as evidence has accumulated and technologies have changed,1 and have been able to extrapolate from well-established ethical principles.Other new technologies lend themselves less well to off-the-peg ethical solutions.

In several articles in this edition the ethical challenges associated with the use lasix heart medicine of artificial intelligence (AI) in medicine are addressed. Although multiple ethical codes and guidelines have been written on the use and development of AI, Hagendorf noted that many of them reiterated a ‘deontologically oriented, action-restricting ethic based on universal abidance of principles and rules’.2 Applying pre-existing ethical frameworks to artificial intelligence is problematic for several reasons. In particular, AI has two characteristics which are very different from the current clinical practice on which traditional medical ethics are based:The so called ‘black box’ of deep learning, whereby a deep neural network is trained to iteratively adapt to make better and better interpretations across layers of complex and non-linear data.3 The resulting (and ever adapting) algorithms are generally too complex to interpret or explain, meaning that part of the process that is being used is opaque even to the users.4 lasix heart medicine This makes it difficult if not impossible to adhere to principles of transparency and informed consent, and restricts the autonomy of the users (both clinicians and patients).Each element of AI has been developed to achieve a particular goal – set by its creators – but has no ‘intent’ beyond achieving that goal. Ethical analyses which include considerations of broader motives or virtuous qualities can therefore not be applied in relation to the AI.These issues are highlighted by S Lee in a student essay.5 Lee examines the NHS code of conduct for artificial intelligence-driven technology, and in particular looks at the conceptualisation of trust within this particular piece of ethical governance.

He draws out the challenge of establishing a trust which is ‘rationally justified lasix heart medicine on sound epistemological bases’ in the context of the ‘black box’ of deep learning. He notes that ‘the Code assumes users are able to and will justify trust by weighing up risk and competence, where risk is the probability of an AI being incompetent at the function it is specified to fulfil, based on performative (ie, quantitative empirical data) information.’To fulfil this, he suggests, the data used to train the AI would need to be available to all users, in order for them to judge the risk of bias6 and other built-in errors in the algorithms developed. This is clearly impractical lasix heart medicine. So he suggests that.

€˜to foster trust, developers and decision makers should provide information lasix heart medicine of how they encapsulate the interests of users. They should show their values are aligned with the users.’ In other words we cannot apply the models of trust which are established in the doctor-patient relationship to AI, and so we need to turn to the developers and decision makers. We should assess their lasix heart medicine intent and competence when designing the system. Lee proposes that a seventh requirement is added to the code relating to the ethical conduct and history of the developers.Turning away from broad ethical codes, Sorell et al7 examine the tension between traditional data ethics and governance (where the emphasis is on minimisation of personal data collection, processing and sharing) and AI (whose success is dependent on maximal data).

They focus their attention on Computational Pathology, where machine learning is applied to digitised whole slide images to improve pattern recognition of cancer lasix heart medicine presence, progression and prognosis. They draw attention to the mismatch between the motivations behind laws to protect both personal data and pathological samples (where the focus is on not using data or samples beyond direct benefit to the individual without their explicit consent) and the application of these laws to AI.They argue that ‘Stereotypical risks of privacy violation occur where data enables inferences about identifiable people’s current health, wealth, sexual practices, political affiliations and friendships. These inferences may allow individuals or lasix heart medicine organisations to manipulate data subjects or make an economic gain from information about them’. Where data has been aggregated, ‘it cannot typically be used to identify the data subjects, or disadvantage them…So while deidentification may not amount to out and out anonymisation in the sense of GDPR, it may amount to anonymisation for most practical purposes.’ Here then, the standards applied to standard data sharing – of full transparency and of explicit consent - are almost impossible to achieve and are antithetical to the goal of improved population health.

In fact ‘the larger the data sets used for training and validation, the lower false positive and negative rates are likely to be, other things being equal, with lasix heart medicine corresponding clinical advantages.’ A different data governance framework is needed for the development of Computational Pathology and other AI dependent diagnostic tools, one which recognises the population benefits of data sharing in this context.Finally, Kempt and Nagel8 (and associated commentary authors) discuss the proposal to use artificial intelligent decision support systems (AI-DSS) as providers of second opinions in medical diagnostics, and again the issue of the ‘black box’ comes into play. The authors state. €˜The difference in evidence-processing and lack of explainability renders an AI-DSS largely accurate but lasix heart medicine unchallengeable. Conflicts between human initial opinions and AI-second opinions, therefore, may not qualify as peer-disagreements, as its ‘reasoning’ is not reason-based like an expert’s evaluation.

Hence, we cannot peer-disagree with an AI-DSS, leaving a responsibility gap when trying to decide what to do in case of a conflict.’ They propose a ‘rule of disagreement’ whereby if the AI-DSS confirms the initial lasix heart medicine opinion no further steps need to be taken, but, where there is disagreement, a second human opinion must be sought. The final arbitrator is the initial clinician.These papers are rich in not only presenting the ethical challenges associated with various elements of AI but in proffering well-reasoned bespoke ethical solutions.Ethics statementsPatient consent for publicationNot applicable.Ethics approvalNot applicable.AbstractBeing a medically qualified patient can be an unpleasant experience for a person who is used to making decisions. For the most part, this applies to the vast majority of lasix heart medicine doctors and other healthcare professionals. Becoming passive and surrendering the decision-making process to others is alien to the medical culture we were taught.

However, when lasix heart medicine as a hospitalised medically qualified patient, one sees fellow patients in difficulty, or deteriorating clinically, unnoticed by medical staff, the question of whether it is ethical to intervene arises. I report my views on this as a largely passive, but still actively thinking patient.ethicspatient perspectiveapplied and professional ethicsclinical ethicsData availability statementThere are no data in this work..

With new technologies come lasix prices walmart new lasix 40mg tablet price in canada ethical (and legal) challenges. Often, we can apply previously established principles, even though it may take some time to fully understand the detail of the new technology - or the questions that arise from it. The International Commission on Radiological Protection, for example, was lasix 40mg tablet price in canada founded in 1928 and has based its advice on balancing the radiation exposure associated with X-rays and CT scans with the diagnostic benefits of the new investigations. They have regularly updated their advice as evidence has accumulated and technologies have changed,1 and have been able to extrapolate from well-established ethical principles.Other new technologies lend themselves less well to off-the-peg ethical solutions. In several articles in this edition the ethical challenges associated with the use of artificial intelligence lasix 40mg tablet price in canada (AI) in medicine are addressed.

Although multiple ethical codes and guidelines have been written on the use and development of AI, Hagendorf noted that many of them reiterated a ‘deontologically oriented, action-restricting ethic based on universal abidance of principles and rules’.2 Applying pre-existing ethical frameworks to artificial intelligence is problematic for several reasons. In particular, AI has two characteristics which are very different from the current clinical practice on which traditional medical ethics are based:The so called ‘black box’ of deep learning, whereby a deep neural network is trained to iteratively adapt to make better and better interpretations across layers of complex and non-linear data.3 The resulting (and ever adapting) algorithms are generally too complex to interpret or explain, meaning that part of the process that is being used is opaque even to the users.4 This makes it difficult if not impossible to adhere to principles of transparency and informed consent, and restricts the autonomy of the users (both clinicians and patients).Each element of AI has been developed to achieve a lasix 40mg tablet price in canada particular goal – set by its creators – but has no ‘intent’ beyond achieving that goal. Ethical analyses which include considerations of broader motives or virtuous qualities can therefore not be applied in relation to the AI.These issues are highlighted by S Lee in a student essay.5 Lee examines the NHS code of conduct for artificial intelligence-driven technology, and in particular looks at the conceptualisation of trust within this particular piece of ethical governance. He draws lasix 40mg tablet price in canada out the challenge of establishing a trust which is ‘rationally justified on sound epistemological bases’ in the context of the ‘black box’ of deep learning. He notes that ‘the Code assumes users are able to and will justify trust by weighing up risk and competence, where risk is the probability of an AI being incompetent at the function it is specified to fulfil, based on performative (ie, quantitative empirical data) information.’To fulfil this, he suggests, the data used to train the AI would need to be available to all users, in order for them to judge the risk of bias6 and other built-in errors in the algorithms developed.

This is clearly lasix 40mg tablet price in canada impractical. So he suggests that. €˜to foster lasix 40mg tablet price in canada trust, developers and decision makers should provide information of how they encapsulate the interests of users. They should show their values are aligned with the users.’ In other words we cannot apply the models of trust which are established in the doctor-patient relationship to AI, and so we need to turn to the developers and decision makers. We should assess their lasix 40mg tablet price in canada intent and competence when designing the system.

Lee proposes that a seventh requirement is added to the code relating to the ethical conduct and history of the developers.Turning away from broad ethical codes, Sorell et al7 examine the tension between traditional data ethics and governance (where the emphasis is on minimisation of personal data collection, processing and sharing) and AI (whose success is dependent on maximal data). They focus their attention on Computational Pathology, where machine learning is applied to digitised whole slide images lasix 40mg tablet price in canada to improve pattern recognition of cancer presence, progression and prognosis. They draw attention to the mismatch between the motivations behind laws to protect both personal data and pathological samples (where the focus is on not using data or samples beyond direct benefit to the individual without their explicit consent) and the application of these laws to AI.They argue that ‘Stereotypical risks of privacy violation occur where data enables inferences about identifiable people’s current health, wealth, sexual practices, political affiliations and friendships. These inferences may allow individuals or organisations to manipulate data subjects or make an economic gain from information about lasix 40mg tablet price in canada them’. Where data has been aggregated, ‘it cannot typically be used to identify the data subjects, or disadvantage them…So while deidentification may not amount to out and out anonymisation in the sense of GDPR, it may amount to anonymisation for most practical purposes.’ Here then, the standards applied to standard data sharing – of full transparency and of explicit consent - are almost impossible to achieve and are antithetical to the goal of improved population health.

In fact ‘the larger the data sets used for training and validation, the lower false positive and negative rates are likely to be, other things being equal, with corresponding clinical advantages.’ A different data governance framework is needed for the development of Computational Pathology and other AI dependent diagnostic tools, one which recognises the population benefits of data sharing in this context.Finally, Kempt and Nagel8 (and associated commentary authors) discuss the proposal to use artificial intelligent decision support systems (AI-DSS) lasix 40mg tablet price in canada as providers of second opinions in medical diagnostics, and again the issue of the ‘black box’ comes into play. The authors state. €˜The difference in evidence-processing and lack of explainability renders an AI-DSS largely accurate but unchallengeable lasix 40mg tablet price in canada. Conflicts between human initial opinions and AI-second opinions, therefore, may not qualify as peer-disagreements, as its ‘reasoning’ is not reason-based like an expert’s evaluation. Hence, we cannot peer-disagree with an AI-DSS, leaving a responsibility gap when lasix 40mg tablet price in canada trying to decide what to do in case of a conflict.’ They propose a ‘rule of disagreement’ whereby if the AI-DSS confirms the initial opinion no further steps need to be taken, but, where there is disagreement, a second human opinion must be sought.

The final arbitrator is the initial clinician.These papers are rich in not only presenting the ethical challenges associated with various elements of AI but in proffering well-reasoned bespoke ethical solutions.Ethics statementsPatient consent for publicationNot applicable.Ethics approvalNot applicable.AbstractBeing a medically qualified patient can be an unpleasant experience for a person who is used to making decisions. For the most part, this applies to the vast majority of doctors and other lasix 40mg tablet price in canada healthcare professionals. Becoming passive and surrendering the decision-making process to others is alien to the medical culture we were taught. However, when as a hospitalised medically qualified patient, one sees fellow patients in difficulty, or lasix 40mg tablet price in canada deteriorating clinically, unnoticed by medical staff, the question of whether it is ethical to intervene arises. I report my views on this as a largely passive, but still actively thinking patient.ethicspatient perspectiveapplied and professional ethicsclinical ethicsData availability statementThere are no data in this work..

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• pregnant or trying to get pregnant
• breast-feeding

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Health disparities have the potential to negatively impact pop over here rural 160mg lasix per day Americans much more than urban Americans. No doubt, rural healthcare currently is facing many challenges, such as lack of bed availability – even as hypertension medications decreases.Dr. Richard Watson is co-founder of Motient, a health IT vendor that equips health systems, accountable care organizations and individual 160mg lasix per day facilities with tools and data designed to help ensure quality in medical transports.Healthcare IT News interviewed Watson to discuss the state of rural healthcare today, the role technology can play in preserving rural healthcare, how CIOs can help ensure sustainable quality in medical transports, and how having the right tools and data when it comes to patient transport can benefit a hospital or health system in terms of patient outcomes, provider satisfaction and overall costs.Q. What is happening with rural healthcare, and specifically bed availability in rural healthcare?.

A. We quickly moved from a lasix crisis to a staffing crisis. This is not something new, and a lot of rural facilities were already dealing with staffing issues prior to the lasix.The first round of hypertension medications tested the system, while the second round crippled it. The rise of agency nursing and the mobility of nurses lured to large paychecks, as well as attrition in rural areas, has really hurt hospitals' ability to staff.The overall problem for rural hospitals right now is sustainability.

We have many hospitals that are at a critical crossroads in deciding what they will be in the coming 10 to 20 years.They serve a decreasing population that still desires to have an acute inpatient facility. What will the hospital of 2030 look like?. Helping facilities understand their true purpose and their potential for revenue is directly dependent on the data they have around their patient population.Q. What do you see with these trends in the next year?.

A. There's no doubt that 2022 will be a moment to come up for air. As the economics of rural healthcare change, hospitals' analysis (or lack thereof) regarding how they fit into their ecosystem will determine how rural healthcare is able to move forward.The ability to do more with what you have, and the flexibility to care for those in your community, are core hallmarks of rural healthcare. I think facilities will have to capitalize on these strengths in order to come out in a positive way from the lasix.Q.

How can technology play a role in preserving healthcare in rural America?. A. A lot has been made of the role technology can play in rural healthcare. I think there are many solutions that get passed on to rural facilities that end up becoming onerous for those who are using them.

More time is spent maintaining the systems and educating the users than anything else. There is little of benefit or value.In the coming decade, direct access to information, the ability to do telehealth, and the tools to enable data analysis around the personality of rural facilities will be important. Facilities need to become very focused on who they are and what their mission is.By using technology to understand the health patterns of their communities and focusing on providing services that keep people close to home for the majority of their care, healthcare organizations can find the answer to quality and sustainability questions.I do think we have to look at reimbursement in rural areas and understand that much of what comes down the pike, with regard to quality metrics and edicts, does not fit well with the reality of rural health. All of the geographic and demographic offsets will do little to counterbalance that.

It seems the current reimbursement schema allows rural facilities to barely keep their heads above water.Q. You suggest it's a priority for healthcare provider organization CIOs to get the data required to ensure sustainable quality in medical transports. Why?. And how can they do that?.

A. This is a question I think is overlooked by most smaller facilities. We talk a lot about population health and the ability to control the behavior of people with chronic disease to support optimal outcomes. It's a lofty goal and certainly something we need to strive for, but even more important is a facility's understanding of patient movement throughout their ecosystem.If a facility can really get a grasp on who is going out their door and what is the make-up of the services that patients are being transferred for, they can begin to identify more avenues for sustainability and enhanced quality.

They can figure out how those patients can be returned to their home base for care, and begin providing the services people need closer to home.The ability to understand how patients move in the system is the key to transforming the system. We spend a lot of time trying to save bandages and use the right antibiotic, but in reality, these measures are worth just nickels and dimes compared to the dollars that move when patients are transferred to the wrong destination and the wrong level of care.Most important, patient movement and financial sustainability are directly tied to quality. We can waste a lot of dollars trying to create quality systems and lose the ability to be sustainable.Q. How can having the right tools and data when it comes to patient transport benefit a hospital or health system when it comes to patient outcomes, provider satisfaction and overall costs?.

A. Visibility is the most important thing in this area. Most facilities will do the right thing if they have the right information in the right time frame. So often, the information is there, but it's only available months after the fact.

Then it becomes just another line on a spreadsheet that never gets used in any significant manner.The ability to know in real time how patients are moving and where they are moving to, and for what reason, allows hospitals to take action in relation to those transfers. Many times, facilities are sending cases out the door that they really could develop a service line for internally.Larger systems often will have acquired smaller facilities or systems that have specialized services within that ecosystem. It is not uncommon for these large systems to have patients going out of network for services that could be provided in network, if only there was real-time visibility into that activity.Most providers will react positively to change if they're given the chance to understand the dynamics of how that change will positively impact the facility. I think this level of control gives everyone a better feeling about the job they're doing and the facility's ability to provide the best care for the patient.Giving providers permission to keep patients they might feel pressured to send to another location – and allowing them to feel justified in using a certain level of resource, whether that be mode of transport or a specialty hospital – is an important prerequisite for providers making good decisions.When sending facilities, receiving facilities and transport agencies all are seeing the same information and the same data, good things can happen.

I genuinely believe that given the right information, these groups will choose to do what's best for the patient.A joint report released this week from the Offices of Inspector General for the Departments of Defense and Veterans Affairs found that the agencies had not taken all necessary actions to achieve interoperability of patient care information when they deployed the Cerner electronic health record system and launched the Joint Health Information Exchange. "Achieving interoperability between the DOD, VA, and external healthcare providers through the deployment of a single EHR system is critical because healthcare providers will have the ability to securely transfer and share health care information for the nation’s 9.6 million DoD armed forces members, dependents and retirees, and 9.21 million enrolled users," read the report. "VA appreciates the recommendations," said VA spokespeople in response to requests for comment from Healthcare IT News. "We consider all opportunities for improvement in VA’s approach to ensuring a complete electronic health record that accomplishes a seamless transition from military service to veteran status.

"We will continue to work closely and effectively with the Federal Electronic Health Record Modernization Office and our DOD colleagues on our joint effort," the spokespeople continued.Requests for comment from DOD and the FEHRM Program Office were not returned by press time. WHY IT MATTERS As outlined in the audit report, Congress directed the DOD and VA to enable interoperability of patient health information between the departments as part of the FY 2008 National Defense Authorization Act. Additional requirements were instituted as part of the FY 2014 NDAA and the FY 2020 NDAA. To meet those interoperability requirements, the agencies contracted with Cerner in 2015 (for DOD) and 2018 (for VA), with plans to deploy its EHR throughout healthcare facilities over the next decade.

The DOD and VA also established the FEHRM Program Office to provide direction and oversight to organizations rolling out the Cerner EHR. "The FEHRM Program Office’s primary mission is to work closely with the DOD and VA to implement a single, interoperable federal EHR and develop and maintain a complete patient record that would enhance patient care and healthcare provider effectiveness," read the joint audit report. "Furthermore, the FEHRM Program Office implemented the Joint Health Information Exchange to enhance the ability of the Departments to securely exchange healthcare information with more than 15,000 external healthcare providers," noted the auditors. However, the watchdogs found that the DOD and VA "did not take all the actions needed to achieve interoperability." Specifically, said the OIGs, the agencies did not:Consistently migrate patient healthcare information from the legacy electronic health care systems into Cerner to create a single, complete patient EHRDevelop interfaces from all medical devices to Cerner Millennium so that patient healthcare information will automatically upload to the system from those devicesEnsure that users were granted access to Cerner Millennium for only the information needed to perform their duties The OIGs pointed the finger at FEHRM for this, saying that it did not develop and implement a plan to achieve interoperability requirements or take an active role to manage the program's success.

"Instead, FEHRM Program Office officials limited their role to facilitating discussions when disputes arose between the DOD and the VA, and would only provide direction if the Departments reported a problem," said the report. "Because the FEHRM Program Office limited its role, the DOD and the VA took separate actions to migrate patient healthcare information, develop interfaces and grant user access to Cerner Millennium," it continued. The OIGs recommended that the FEHRM Program Office develop processes and procedures in accordance with its charter, along with. Determining the type of healthcare information that constitutes a complete EHR Implementing a plan for migrating legacy patient healthcare information neededImplementing a plan for creating interfaces that would allow medical devices to connect and transfer patient healthcare information to Cerner MillenniumImplementing a plan to modify Cerner Millennium user roles to ensure that users are granted access to only the patient healthcare information necessary to perform their job responsibilities "The Deputy Secretary of Defense and Deputy Secretary of Veterans Affairs agreed with the recommendation to review the actions of the FEHRM Program Office and direct the FEHRM Program Office to develop processes and procedures in accordance with the recommendations," said the auditors.

"In addition, the Deputy Secretary of Defense and Deputy Secretary of Veterans Affairs stated that they would ensure the FEHRM Program Office complies with its charter and applicable NDAA requirements," they continued.THE LARGER TREND The EHR modernization effort at the VA has been the subject of several OIG reports over the past year, which raised concerns about cost estimates, training deficiencies, scheduling systems, medication management, ticket-process concerns and care-coordination deficiencies. But the DOD's new EHR implementation also faced its fair share of watchdog scrutiny about its rollout timeline and its handling of patient security. ON THE RECORD "As the DOD and the VA continue to deploy Cerner Millennium, healthcare providers at those facilities should be confident that a patient’s EHR is accurate and complete regardless of where the point of care occurred," said the joint OIG report. Kat Jercich is senior editor of Healthcare IT News.Twitter.

@kjercichEmail. Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication..

Health disparities have the lasix 40mg tablet price in canada potential to negatively impact rural Americans much more than urban Americans. No doubt, rural healthcare currently is facing many challenges, such as lack of bed availability – even as hypertension medications decreases.Dr. Richard Watson is co-founder of Motient, a health IT vendor that equips health systems, accountable care organizations and individual facilities with tools and data designed to help ensure quality in medical transports.Healthcare IT News lasix 40mg tablet price in canada interviewed Watson to discuss the state of rural healthcare today, the role technology can play in preserving rural healthcare, how CIOs can help ensure sustainable quality in medical transports, and how having the right tools and data when it comes to patient transport can benefit a hospital or health system in terms of patient outcomes, provider satisfaction and overall costs.Q. What is happening with rural healthcare, and specifically bed availability in rural healthcare?. A.

We quickly moved from a lasix crisis to a staffing crisis. This is not something new, and a lot of rural facilities were already dealing with staffing issues prior to the lasix.The first round of hypertension medications tested the system, while the second round crippled it. The rise of agency nursing and the mobility of nurses lured to large paychecks, as well as attrition in rural areas, has really hurt hospitals' ability to staff.The overall problem for rural hospitals right now is sustainability. We have many hospitals that are at a critical crossroads in deciding what they will be in the coming 10 to 20 years.They serve a decreasing population that still desires to have an acute inpatient facility. What will the hospital of 2030 look like?.

Helping facilities understand their true purpose and their potential for revenue is directly dependent on the data they have around their patient population.Q. What do you see with these trends in the next year?. A. There's no doubt that 2022 will be a moment to come up for air. As the economics of rural healthcare change, hospitals' analysis (or lack thereof) regarding how they fit into their ecosystem will determine how rural healthcare is able to move forward.The ability to do more with what you have, and the flexibility to care for those in your community, are core hallmarks of rural healthcare.

I think facilities will have to capitalize on these strengths in order to come out in a positive way from the lasix.Q. How can technology play a role in preserving healthcare in rural America?. A. A lot has been made of the role technology can play in rural healthcare. I think there are many solutions that get passed on to rural facilities that end up becoming onerous for those who are using them.

More time is spent maintaining the systems and educating the users than anything else. There is little of benefit or value.In the coming decade, direct access to information, the ability to do telehealth, and the tools to enable data analysis around the personality of rural facilities will be important. Facilities need to become very focused on who they are and what their mission is.By using technology to understand the health patterns of their communities and focusing on providing services that keep people close to home for the majority of their care, healthcare organizations can find the answer to quality and sustainability questions.I do think we have to look at reimbursement in rural areas and understand that much of what comes down the pike, with regard to quality metrics and edicts, does not fit well with the reality of rural health. All of the geographic and demographic offsets will do little to counterbalance that. It seems the current reimbursement schema allows rural facilities to barely keep their heads above water.Q.

You suggest it's a priority for healthcare provider organization CIOs to get the data required to ensure sustainable quality in medical transports. Why?. And how can they do that?. A. This is a question I think is overlooked by most smaller facilities.

We talk a lot about population health and the ability to control the behavior of people with chronic disease to support optimal outcomes. It's a lofty goal and certainly something we need to strive for, but even more important is a facility's understanding of patient movement throughout their ecosystem.If a facility can really get a grasp on who is going out their door and what is the make-up of the services that patients are being transferred for, they can begin to identify more avenues for sustainability and enhanced quality. They can figure out how those patients can be returned to their home base for care, and begin providing the services people need closer to home.The ability to understand how patients move in the system is the key to transforming the system. We spend a lot of time trying to save bandages and use the right antibiotic, but in reality, these measures are worth just nickels and dimes compared to the dollars that move when patients are transferred to the wrong destination and the wrong level of care.Most important, patient movement and financial sustainability are directly tied to quality. We can waste a lot of dollars trying to create quality systems and lose the ability to be sustainable.Q.

How can having the right tools and data when it comes to patient transport benefit a hospital or health system when it comes to patient outcomes, provider satisfaction and overall costs?. A. Visibility is the most important thing in this area. Most facilities will do the right thing if they have the right information in the right time frame. So often, the information is there, but it's only available months after the fact.

Then it becomes just another line on a spreadsheet that never gets used in any significant manner.The ability to know in real time how patients are moving and where they are moving to, and for what reason, allows hospitals to take action in relation to those transfers. Many times, facilities are sending cases out the door that they really could develop a service line for internally.Larger systems often will have acquired smaller facilities or systems that have specialized services within that ecosystem. It is not uncommon for these large systems to have patients going out of network for services that could be provided in network, if only there was real-time visibility into that activity.Most providers will react positively to change if they're given the chance to understand the dynamics of how that change will positively impact the facility. I think this level of control gives everyone a better feeling about the job they're doing and the facility's ability to provide the best care for the patient.Giving providers permission to keep patients they might feel pressured to send to another location – and allowing them to feel justified in using a certain level of resource, whether that be mode of transport or a specialty hospital – is an important prerequisite for providers making good decisions.When sending facilities, receiving facilities and transport agencies all are seeing the same information and the same data, good things can happen. I genuinely believe that given the right information, these groups will choose to do what's best for the patient.A joint report released this week from the Offices of Inspector General for the Departments of Defense and Veterans Affairs found that the agencies had not taken all necessary actions to achieve interoperability of patient care information when they deployed the Cerner electronic health record system and launched the Joint Health Information Exchange.

"Achieving interoperability between the DOD, VA, and external healthcare providers through the deployment of a single EHR system is critical because healthcare providers will have the ability to securely transfer and share health care information for the nation’s 9.6 million DoD armed forces members, dependents and retirees, and 9.21 million enrolled users," read the report. "VA appreciates the recommendations," said VA spokespeople in response to requests for comment from Healthcare IT News. "We consider all opportunities for improvement in VA’s approach to ensuring a complete electronic health record that accomplishes a seamless transition from military service to veteran status. "We will continue to work closely and effectively with the Federal Electronic Health Record Modernization Office and our DOD colleagues on our joint effort," the spokespeople continued.Requests for comment from DOD and the FEHRM Program Office were not returned by press time. WHY IT MATTERS As outlined in the audit report, Congress directed the DOD and VA to enable interoperability of patient health information between the departments as part of the FY 2008 National Defense Authorization Act.

Additional requirements were instituted as part of the FY 2014 NDAA and the FY 2020 NDAA. To meet those interoperability requirements, the agencies contracted with Cerner in 2015 (for DOD) and 2018 (for VA), with plans to deploy its EHR throughout healthcare facilities over the next decade. The DOD and VA also established the FEHRM Program Office to provide direction and oversight to organizations rolling out the Cerner EHR. "The FEHRM Program Office’s primary mission is to work closely with the DOD and VA to implement a single, interoperable federal EHR and develop and maintain a complete patient record that would enhance patient care and healthcare provider effectiveness," read the joint audit report. "Furthermore, the FEHRM Program Office implemented the Joint Health Information Exchange to enhance the ability of the Departments to securely exchange healthcare information with more than 15,000 external healthcare providers," noted the auditors.

However, the watchdogs found that the DOD and VA "did not take all the actions needed to achieve interoperability." Specifically, said the OIGs, the agencies did not:Consistently migrate patient healthcare information from the legacy electronic health care systems into Cerner to create a single, complete patient EHRDevelop interfaces from all medical devices to Cerner Millennium so that patient healthcare information will automatically upload to the system from those devicesEnsure that users were granted access to Cerner Millennium for only the information needed to perform their duties The OIGs pointed the finger at FEHRM for this, saying that it did not develop and implement a plan to achieve interoperability requirements or take an active role to manage the program's success. "Instead, FEHRM Program Office officials limited their role to facilitating discussions when disputes arose between the DOD and the VA, and would only provide direction if the Departments reported a problem," said the report. "Because the FEHRM Program Office limited its role, the DOD and the VA took separate actions to migrate patient healthcare information, develop interfaces and grant user access to Cerner Millennium," it continued. The OIGs recommended that the FEHRM Program Office develop processes and procedures in accordance with its charter, along with. Determining the type of healthcare information that constitutes a complete EHR Implementing a plan for migrating legacy patient healthcare information neededImplementing a plan for creating interfaces that would allow medical devices to connect and transfer patient healthcare information to Cerner MillenniumImplementing a plan to modify Cerner Millennium user roles to ensure that users are granted access to only the patient healthcare information necessary to perform their job responsibilities "The Deputy Secretary of Defense and Deputy Secretary of Veterans Affairs agreed with the recommendation to review the actions of the FEHRM Program Office and direct the FEHRM Program Office to develop processes and procedures in accordance with the recommendations," said the auditors.

"In addition, the Deputy Secretary of Defense and Deputy Secretary of Veterans Affairs stated that they would ensure the FEHRM Program Office complies with its charter and applicable NDAA requirements," they continued.THE LARGER TREND The EHR modernization effort at the VA has been the subject of several OIG reports over the past year, which raised concerns about cost estimates, training deficiencies, scheduling systems, medication management, ticket-process concerns and care-coordination deficiencies. But the DOD's new EHR implementation also faced its fair share of watchdog scrutiny about its rollout timeline and its handling of patient security. ON THE RECORD "As the DOD and the VA continue to deploy Cerner Millennium, healthcare providers at those facilities should be confident that a patient’s EHR is accurate and complete regardless of where the point of care occurred," said the joint OIG report. Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichEmail.

Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication..

Is lasix safe to take

The U.S is lasix safe to take. Department of Justice on Monday announced that it had taken action against two individuals accused of using REvil ransomware to attack U.S. Businesses and government is lasix safe to take agencies.

In a press release, the DOJ said it had charged a Ukrainian man with multiple ransomware attacks, including an attack in July of this year against the remote managing software company Kaseya. It had also seized $6 million in is lasix safe to take funds traceable to alleged ransomware payments received by a Russian man charged with deploying REvil attacks against several entities. "Cybercrime is a serious threat to our country.

To our personal safety, to the health of our is lasix safe to take economy, and to our national security," said U.S. Attorney General Merrick Garland in a statement. "Our is lasix safe to take message today is clear.

The United States, together with our allies, will do everything in our power to identify the perpetrators of ransomware attacks, to bring them to justice, and to recover the funds they have stolen from their victims," Garland continued. WHY IT MATTERS REvil ransomware has been triggering alarms for healthcare cybersecurity experts, even after the group appeared to vanish earlier this year. In June, is lasix safe to take a hospital attack attributed to the group potentially exposed the information of 1.3 million people.

The DOJ indictments on Monday concern two hackers accused of using the ransomware to target U.S. Organizations. A 22-year-old Ukranian named Yaroslav Vasinskyi and a 28-year-old Russian named Yevgeniy Polyanin.

The agency has accused Vasinskyi of deploying malicious REvil code throughout a Kaseya product, eventually establishing endpoints on Kaseya customer networks. In turn, ransomware was executed on those computers. He is suspected of attacking roughly 2,500 targets, and collecting $2.3 million in ransom, according to CNBC.Vasinkyi, who was arrested in Poland in October, faces 115 years in prison.

The U.S. Has asked for him to be extradited. Polyanin, meanwhile, is believed to still be abroad, said the DOJ.

He faces 145 years in prison. Meanwhile, Romanian authorities also announced Monday that they had arrested two individuals suspected of involvement in 5,000 REvil ransomware s. This was in addition to Vasinskyi and two other REvil affiliates arrested since February 2021.

"The arrest of Yaroslav Vasinskyi, the charges against Yevgeniy Polyanin and seizure of $6.1 million of his assets, and the arrests of two other Sodinokibi/REvil actors in Romania are the culmination of close collaboration with our international, U.S. Government and especially our private sector partners," said FBI Director Christopher Wray in a statement. "The FBI has worked creatively and relentlessly to counter the criminal hackers behind Sodinokibi/REvil," he added.

"Ransomware groups like them pose a serious, unacceptable threat to our safety and our economic well-being. We will continue to broadly target their actors and facilitators, their infrastructure, and their money, wherever in the world those might be," said Wray. THE LARGER TRENDPresident Joe Biden's administration has taken a no-nonsense approach to cyberattacks.

This summer, U.S. Secretary of Commerce Gina Raimondo implied that military action might be on the table when it comes to a ransomware response. The Cybersecurity and Infrastructure Security Agency this past week also ordered federal agencies to patch known flaws carrying "significant risk" to the federal enterprise – many within the next few weeks.

ON THE RECORD "These two defendants deployed some of the internet’s most virulent code, authored by REvil, to hijack victim computers," said Acting U.S. Attorney Chad E. Meacham for the Northern District of Texas, in a statement concerning Vasinskyi and Polyanin."In a matter of months, the Justice Department identified the perpetrators, effected an arrest, and seized a significant sum of money.

The Department will delve into the darkest corners of the internet and the furthest reaches of the globe to track down cyber criminals," he said. Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichEmail.

Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication.This past week, the U.S. Food and Drug Administration published draft guidance for its Content of Premarket Submissions for Device Software Functions.WHY IT MATTERSThe guidance, posted online on November 4, intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software functions.The FDA's draft recommendations pertain to device software functions – software in a medical device (SiMD) and software as a medical device (SaMD), most notably – and describe data that would be generated and documented during software design, development, verification and validation.The guidance, once finalized after a public content period, would replace the FDA’s more than 16-year-old Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.It represents a substantial reworking of that document, which was first issued in May 2005, when the existing technology landscape could hardly have been imagined. Just as the maturity and capabilities of medical devices have evolved significantly since then, so has the agency's regulatory approach.The new draft "describes the information that the FDA considers important during its evaluation of the safety and effectiveness for device software with one or more device functions, including both software in a medical device and software as a medical device," said Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health."We anticipate this draft guidance, which fulfills FDA’s commitment in MDUFA IV, will provide clarity, simplicity and harmonization with current best practices and recognized voluntary consensus standards, once finalized," he added.Comments can be submitted online through February 2, 2022."We look forward to receiving comments on this draft guidance and to providing final guidance to stakeholders as part of our efforts to promote innovation of safe and effective devices for the benefit of public health," said Patel.THE LARGER TRENDSpeaking a year ago about the promise and potential for medical technology, especially as artificial intelligence and machine learning evolve, Patel made note of FDA's total product life cycle approach to AI-powered software-as-a-medical devices.The goal, he said in October 2020, was that "FDA oversight would provide the level of trust and confidence to the users, at the same time leveraging transparency and pre-market assurance, as well as ongoing monitoring of those products that are learning on the fly.

And we are looking to see what we can do to enhance this framework going forward, and understand how the regulatory system can enable that."This past month, meanwhile, the agency published another document. A list of "guiding principles" aimed at helping promote the safe and effective development of medical devices that use AI.The hope is to lay the foundation for what FDA calls Good Machine Learning Practice. "As the AI/ML medical device field evolves, so too must GMLP best practice and consensus standards," according to the agency.ON THE RECORD"As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into medical devices," said Patel this past week, announcing the draft guidance on device software."The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions that is aligned with current standards and best practices."National Nurses United and the California Nurses Association released a joint statement this past week criticizing Kaiser Permanente's aims to expand advanced hospital services into patients' homes.

The unions accused the health system of trying to maximize profits and endangering patients, along with undermining the role of registered nurses in providing care. "Nurses, more than any other healthcare staff, spend the most time with patients," said the unions in the statement. "We reject Kaiser’s assertion that iPads, cameras, monitors, and the occasional visit by likely lesser-skilled and unlicensed personnel are in any way comparable to the skilled, expert nursing care and social emotional support we RNs provide every moment of every shift," they added.

"Nurses have always and will continue to play a critically important and highly valued role at Kaiser Permanente," said Kaiser representatives in response to a request for comment. "The Advanced Care at Home Program does not limit the role of nurses in hospitals." "The Kaiser Permanente Advanced Care at Home is an innovative person centered program rooted in quality, safety and patient satisfaction. Patients enrolled in the program must meet established clinical and safety criteria," the representatives continued.

"Regardless of whether the patients are receiving care in the comfort of their own home or in a hospital we hold ourselves to the same high standard of care. The program empowers multidisciplinary care teams to provide the right care at the right time while meeting our patients where they want to be," they added. WHY IT MATTERS In October, Kaiser – along with the Mayo Clinic and Medically Home – announced that it had launched a coalition aimed at creating a pathway to access at-home hospital-level services.

The systems noted the advantages of the model, saying it can be a safe, effective way to provide care to patients where they are. Patient satisfaction levels were high, said representatives in an interview with Healthcare IT News. Mayo Clinic's Dr.

Michael Maniaci also pointed to lower readmission rates and equivalent fall and rates among advanced care at home patients. Kaiser is currently piloting the program at two sites in California but intends to expand it system-wide, the NNU and CNA noted. According to the unions, bringing hospital-level services outside a facility's walls robs patients of the benefits of being physically close to other specialized departments, units and equipment.

"Nurses know that our patients can be fragile and their condition can deteriorate quickly and unexpectedly. We are appalled by the idea that our patients could be stranded at home in case of an emergency or adverse event, with no way to get immediate help or medical intervention and treatment," said the statement. The unions also said they were skeptical of reported patient outcomes given the size of the pilot programs and the studies, and accused Kaiser and other hospital systems of treating the model as a "gold mine."They flagged the danger of shifting care onto laypeople, especially women, and raised concerns about the potential of such initiatives to exacerbate racial disparities.

"The industry will accuse registered nurses of opposing this and similar programs because we simply want to 'keep our jobs,'" read the statement. "That’s exactly right. Hospital nurses do want to keep our jobs because we know our profession serves a critical role in our society.

We are highly educated, knowledgeable, and skilled professionals who care for the sickest of the sick with our healing touch. We practice the art and science of nursing and all patients must have equal access to our care," it continued. THE LARGER TREND Amidst the hypertension medications lasix, Kaiser has shifted more resources and strategy toward expanding beyond a brick-and-mortar health system model.

In addition to its investment in Medically Home Group, the health system also launched a "virtual-first" health plan in Washington this past year aimed at centering telehealth as a foundational modality of care. But the system, and other stakeholders wishing to expand virtual services, face potential hurdles in Congress and at federal agencies. When the public health emergency ends, so too will many telehealth regulatory flexibilities – which has advocates concerned.

ON THE RECORD "Registered nurses are demanding that the hospital industry, the public, and private and government payers such as the Centers for Medicare and Medicaid Services abandon these plans to send home patients who should be admitted to hospitals," said the unions' statement. "As a country, we need to invest in the proven health care infrastructure and RN workforce we know we need – and that our current hypertension medications lasix painfully reconfirms we must have – to care for the nation’s patients," it continued. Kat Jercich is senior editor of Healthcare IT News.Twitter.

@kjercichEmail. Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication.As part of the HIMSS Healthcare Cybersecurity Forum virtual event December 6-7, Aimee Cardwell, the chief information security officer for the UnitedHealth Group at Optum Technology, will dig into the subject of ransomware in an educational session entitled "Ransomware. Today's Threat Landscape." Optum Technology is UnitedHealth Group's IT and services subsidiary.Ransomware continues to expose the vulnerabilities in the global network from the government to infrastructure to hospitals.

In this session, Cardwell will discuss the current threat landscape and the ransomware to watch out for.In a sneak-peek of the session, Healthcare IT News interviewed Cardwell to get her to explain the cybersecurity landscape and some of the best defenses against ransomware.Q. What is the current threat landscape for healthcare organizations?. A.

We see three major categories of threat. First, ransomware. According to the Wall Street Journal, ransomware has become the most lucrative form of malware globally, generating $350 million in 2020, while causing over $20 billion in damages and downtime over the same period.The healthcare industry makes up 11.6% of all ransomware attacks.

As an example, Ireland's Health Service Executive is responsible for healthcare and social services across Ireland. They were attacked with ransomware that caused a shutdown of all IT systems. Eight weeks after the attack, services were still only 90% recovered.Second, zero-day vulnerabilities.

These refer to a vulnerability in a system or device that has been discovered but is not yet patched. You may recall hearing about PrintNightmare, which took advantage of a zero-day vulnerability in Microsoft's print spooler, allowing a user on the network to gain elevated access on any system with print capability.And third, supply chain attacks. These involve tampering with the digital infrastructure of a company's software to install undetectable malware to bring harm to organizations further down the supply chain network.

You may remember reading about Kaseya, a software provider that provides remote management monitoring, which was the victim of an attack by the REvil ransomware group over the Independence Day weekend this year.The attacker used a previously unknown zero-day attack against the Kaseya platform. By targeting Kaseya's software, the hackers opened the door to infect more computers in companies that use Kaseya's products. Kaseya was interesting because it was a supply chain attack that used a zero-day vulnerability to install ransomware, so it used all three major categories in one threat.Q.

What particular ransomware should healthcare CISOs and CIOs be watching for, and why?. A. We don't look for one specific type of ransomware.

Instead, we are vigilant in the prevention of all kinds of attacks and intrusion. Ransomware is a continual evolving risk, and while attacks by organizations like REvil may get more attention than others, they all present an existential risk to the delivery of care.The impact of a particular variant of ransomware is more dependent upon your controls than the actual ransomware. Your impact can be reduced if you have network segmentation, if you implement zero trust techniques and if you use multifactor authentication.

In addition to those strategies, a robust monitoring program can help you catch intrusions early and reduce impact.The goal is prevention, but prevention has its limits. The next step is impact reduction. To reduce impact, look at all critical systems and applications, both internal and external, and determine how long it would take to recover the application if any were impacted by ransomware.How much would it cost to shorten that time?.

Would it be worth it?. Rapid recovery, and having your data encrypted at rest and in transit, are the best ways to reduce impact, and thwart ransomware attacks.Q. What are some of the best defenses against today's ransomware?.

A. To ensure we are protected, we rely on some fundamental techniques to reduce our vulnerability to ransomware:Email filtering. More than 90% of the email that comes to our servers is discarded because it is spam, junk or contains malicious content.Stronger passwords.

Windows Hello allows a computer to recognize an employee using face or fingerprint, improving user experience while reducing the likelihood of brute force password attack.Multi-factor authentication. Stolen or reused passwords, as in the Colonial Pipeline attack, take advantage of poorly configured remote access solutions that do not use multifactor authentication.Software and operating system patching. An automated, AI-driven approach for vulnerability management enables the application of patches and fixes more rapidly.User education.

The end user is often the weakest link when it comes to cybersecurity, and that is what attackers are counting on. End user security and awareness training is an inexpensive and effective way to reduce incidents.Aimee Cardwell will explain more in the session "Ransomware. Today's Threat Landscape." It's scheduled to air from 12:25-12:45 p.m.

ET on Monday December 6.Twitter. @SiwickiHealthITEmail the writer. Bsiwicki@himss.orgHealthcare IT News is a HIMSS Media publication..

The U.S lasix 40mg tablet price in canada. Department of Justice on Monday announced that it had taken action against two individuals accused of using REvil ransomware to attack U.S. Businesses and government lasix 40mg tablet price in canada agencies. In a press release, the DOJ said it had charged a Ukrainian man with multiple ransomware attacks, including an attack in July of this year against the remote managing software company Kaseya.

It had also seized $6 million in funds traceable to alleged ransomware payments received by a lasix 40mg tablet price in canada Russian man charged with deploying REvil attacks against several entities. "Cybercrime is a serious threat to our country. To our personal safety, to the health of our economy, and to our national lasix 40mg tablet price in canada security," said U.S. Attorney General Merrick Garland in a statement.

"Our message lasix 40mg tablet price in canada today is clear. The United States, together with our allies, will do everything in our power to identify the perpetrators of ransomware attacks, to bring them to justice, and to recover the funds they have stolen from their victims," Garland continued. WHY IT MATTERS REvil ransomware has been triggering alarms for healthcare cybersecurity experts, even after the group appeared to vanish earlier this year. In June, a hospital attack attributed to the group potentially exposed the information of 1.3 million lasix 40mg tablet price in canada people.

The DOJ indictments on Monday concern two hackers accused of using the ransomware to target U.S. Organizations. A 22-year-old Ukranian named Yaroslav Vasinskyi and a 28-year-old Russian named Yevgeniy Polyanin. The agency has accused Vasinskyi of deploying malicious REvil code throughout a Kaseya product, eventually establishing endpoints on Kaseya customer networks.

In turn, ransomware was executed on those computers. He is suspected of attacking roughly 2,500 targets, and collecting $2.3 million in ransom, according to CNBC.Vasinkyi, who was arrested in Poland in October, faces 115 years in prison. The U.S. Has asked for him to be extradited.

Polyanin, meanwhile, is believed to still be abroad, said the DOJ. He faces 145 years in prison. Meanwhile, Romanian authorities also announced Monday that they had arrested two individuals suspected of involvement in 5,000 REvil ransomware s. This was in addition to Vasinskyi and two other REvil affiliates arrested since February 2021.

"The arrest of Yaroslav Vasinskyi, the charges against Yevgeniy Polyanin and seizure of $6.1 million of his assets, and the arrests of two other Sodinokibi/REvil actors in Romania are the culmination of close collaboration with our international, U.S. Government and especially our private sector partners," said FBI Director Christopher Wray in a statement. "The FBI has worked creatively and relentlessly to counter the criminal hackers behind Sodinokibi/REvil," he added. "Ransomware groups like them pose a serious, unacceptable threat to our safety and our economic well-being.

We will continue to broadly target their actors and facilitators, their infrastructure, and their money, wherever in the world those might be," said Wray. THE LARGER TRENDPresident Joe Biden's administration has taken a no-nonsense approach to cyberattacks. This summer, U.S. Secretary of Commerce Gina Raimondo implied that military action might be on the table when it comes to a ransomware response.

The Cybersecurity and Infrastructure Security Agency this past week also ordered federal agencies to patch known flaws carrying "significant risk" to the federal enterprise – many within the next few weeks. ON THE RECORD "These two defendants deployed some of the internet’s most virulent code, authored by REvil, to hijack victim computers," said Acting U.S. Attorney Chad E. Meacham for the Northern District of Texas, in a statement concerning Vasinskyi and Polyanin."In a matter of months, the Justice Department identified the perpetrators, effected an arrest, and seized a significant sum of money.

The Department will delve into the darkest corners of the internet and the furthest reaches of the globe to track down cyber criminals," he said. Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichEmail. Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication.This past week, the U.S.

Food and Drug Administration published draft guidance for its Content of Premarket Submissions for Device Software Functions.WHY IT MATTERSThe guidance, posted online on November 4, intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software functions.The FDA's draft recommendations pertain to device software functions – software in a medical device (SiMD) and software as a medical device (SaMD), most notably – and describe data that would be generated and documented during software design, development, verification and validation.The guidance, once finalized after a public content period, would replace the FDA’s more than 16-year-old Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.It represents a substantial reworking of that document, which was first issued in May 2005, when the existing technology landscape could hardly have been imagined. Just as the maturity and capabilities of medical devices have evolved significantly since then, so has the agency's regulatory approach.The new draft "describes the information that the FDA considers important during its evaluation of the safety and effectiveness for device software with one or more device functions, including both software in a medical device and software as a medical device," said Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health."We anticipate this draft guidance, which fulfills FDA’s commitment in MDUFA IV, will provide clarity, simplicity and harmonization with current best practices and recognized voluntary consensus standards, once finalized," he added.Comments can be submitted online through February 2, 2022."We look forward to receiving comments on this draft guidance and to providing final guidance to stakeholders as part of our efforts to promote innovation of safe and effective devices for the benefit of public health," said Patel.THE LARGER TRENDSpeaking a year ago about the promise and potential for medical technology, especially as artificial intelligence and machine learning evolve, Patel made note of FDA's total product life cycle approach to AI-powered software-as-a-medical devices.The goal, he said in October 2020, was that "FDA oversight would provide the level of trust and confidence to the users, at the same time leveraging transparency and pre-market assurance, as well as ongoing monitoring of those products that are learning on the fly. And we are looking to see what we can do to enhance this framework going forward, and understand how the regulatory system can enable that."This past month, meanwhile, the agency published another document. A list of "guiding principles" aimed at helping promote the safe and effective development of medical devices that use AI.The hope is to lay the foundation for what FDA calls Good Machine Learning Practice.

"As the AI/ML medical device field evolves, so too must GMLP best practice and consensus standards," according to the agency.ON THE RECORD"As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into medical devices," said Patel this past week, announcing the draft guidance on device software."The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions that is aligned with current standards and best practices."National Nurses United and the California Nurses Association released a joint statement this past week criticizing Kaiser Permanente's aims to expand advanced hospital services into patients' homes. The unions accused the health system of trying to maximize profits and endangering patients, along with undermining the role of registered nurses in providing care. "Nurses, more than any other healthcare staff, spend the most time with patients," said the unions in the statement. "We reject Kaiser’s assertion that iPads, cameras, monitors, and the occasional visit by likely lesser-skilled and unlicensed personnel are in any way comparable to the skilled, expert nursing care and social emotional support we RNs provide every moment of every shift," they added.

"Nurses have always and will continue to play a critically important and highly valued role at Kaiser Permanente," said Kaiser representatives in response to a request for comment. "The Advanced Care at Home Program does not limit the role of nurses in hospitals." "The Kaiser Permanente Advanced Care at Home is an innovative person centered program rooted in quality, safety and patient satisfaction. Patients enrolled in the program must meet established clinical and safety criteria," the representatives continued. "Regardless of whether the patients are receiving care in the comfort of their own home or in a hospital we hold ourselves to the same high standard of care.

The program empowers multidisciplinary care teams to provide the right care at the right time while meeting our patients where they want to be," they added. WHY IT MATTERS In October, Kaiser – along with the Mayo Clinic and Medically Home – announced that it had launched a coalition aimed at creating a pathway to access at-home hospital-level services. The systems noted the advantages of the model, saying it can be a safe, effective way to provide care to patients where they are. Patient satisfaction levels were high, said representatives in an interview with Healthcare IT News.

Mayo Clinic's Dr. Michael Maniaci also pointed to lower readmission rates and equivalent fall and rates among advanced care at home patients. Kaiser is currently piloting the program at two sites in California but intends to expand it system-wide, the NNU and CNA noted. According to the unions, bringing hospital-level services outside a facility's walls robs patients of the benefits of being physically close to other specialized departments, units and equipment.

"Nurses know that our patients can be fragile and their condition can deteriorate quickly and unexpectedly. We are appalled by the idea that our patients could be stranded at home in case of an emergency or adverse event, with no way to get immediate help or medical intervention and treatment," said the statement. The unions also said they were skeptical of reported patient outcomes given the size of the pilot programs and the studies, and accused Kaiser and other hospital systems of treating the model as a "gold mine."They flagged the danger of shifting care onto laypeople, especially women, and raised concerns about the potential of such initiatives to exacerbate racial disparities. "The industry will accuse registered nurses of opposing this and similar programs because we simply want to 'keep our jobs,'" read the statement.

"That’s exactly right. Hospital nurses do want to keep our jobs because we know our profession serves a critical role in our society. We are highly educated, knowledgeable, and skilled professionals who care for the sickest of the sick with our healing touch. We practice the art and science of nursing and all patients must have equal access to our care," it continued.

THE LARGER TREND Amidst the hypertension medications lasix, Kaiser has shifted more resources and strategy toward expanding beyond a brick-and-mortar health system model. In addition to its investment in Medically Home Group, the health system also launched a "virtual-first" health plan in Washington this past year aimed at centering telehealth as a foundational modality of care. But the system, and other stakeholders wishing to expand virtual services, face potential hurdles in Congress and at federal agencies. When the public health emergency ends, so too will many telehealth regulatory flexibilities – which has advocates concerned.

ON THE RECORD "Registered nurses are demanding that the hospital industry, the public, and private and government payers such as the Centers for Medicare and Medicaid Services abandon these plans to send home patients who should be admitted to hospitals," said the unions' statement. "As a country, we need to invest in the proven health care infrastructure and RN workforce we know we need – and that our current hypertension medications lasix painfully reconfirms we must have – to care for the nation’s patients," it continued. Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichEmail.

Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication.As part of the HIMSS Healthcare Cybersecurity Forum virtual event December 6-7, Aimee Cardwell, the chief information security officer for the UnitedHealth Group at Optum Technology, will dig into the subject of ransomware in an educational session entitled "Ransomware. Today's Threat Landscape." Optum Technology is UnitedHealth Group's IT and services subsidiary.Ransomware continues to expose the vulnerabilities in the global network from the government to infrastructure to hospitals. In this session, Cardwell will discuss the current threat landscape and the ransomware to watch out for.In a sneak-peek of the session, Healthcare IT News interviewed Cardwell to get her to explain the cybersecurity landscape and some of the best defenses against ransomware.Q. What is the current threat landscape for healthcare organizations?.

A. We see three major categories of threat. First, ransomware. According to the Wall Street Journal, ransomware has become the most lucrative form of malware globally, generating $350 million in 2020, while causing over $20 billion in damages and downtime over the same period.The healthcare industry makes up 11.6% of all ransomware attacks.

As an example, Ireland's Health Service Executive is responsible for healthcare and social services across Ireland. They were attacked with ransomware that caused a shutdown of all IT systems. Eight weeks after the attack, services were still only 90% recovered.Second, zero-day vulnerabilities. These refer to a vulnerability in a system or device that has been discovered but is not yet patched.

You may recall hearing about PrintNightmare, which took advantage of a zero-day vulnerability in Microsoft's print spooler, allowing a user on the network to gain elevated access on any system with print capability.And third, supply chain attacks. These involve tampering with the digital infrastructure of a company's software to install undetectable malware to bring harm to organizations further down the supply chain network. You may remember reading about Kaseya, a software provider that provides remote management monitoring, which was the victim of an attack by the REvil ransomware group over the Independence Day weekend this year.The attacker used a previously unknown zero-day attack against the Kaseya platform. By targeting Kaseya's software, the hackers opened the door to infect more computers in companies that use Kaseya's products.

Kaseya was interesting because it was a supply chain attack that used a zero-day vulnerability to install ransomware, so it used all three major categories in one threat.Q. What particular ransomware should healthcare CISOs and CIOs be watching for, and why?. A. We don't look for one specific type of ransomware.

Instead, we are vigilant in the prevention of all kinds of attacks and intrusion. Ransomware is a continual evolving risk, and while attacks by organizations like REvil may get more attention than others, they all present an existential risk to the delivery of care.The impact of a particular variant of ransomware is more dependent upon your controls than the actual ransomware. Your impact can be reduced if you have network segmentation, if you implement zero trust techniques and if you use multifactor authentication. In addition to those strategies, a robust monitoring program can help you catch intrusions early and reduce impact.The goal is prevention, but prevention has its limits.

The next step is impact reduction. To reduce impact, look at all critical systems and applications, both internal and external, and determine how long it would take to recover the application if any were impacted by ransomware.How much would it cost to shorten that time?. Would it be worth it?. Rapid recovery, and having your data encrypted at rest and in transit, are the best ways to reduce impact, and thwart ransomware attacks.Q.

What are some of the best defenses against today's ransomware?. A. To ensure we are protected, we rely on some fundamental techniques to reduce our vulnerability to ransomware:Email filtering. More than 90% of the email that comes to our servers is discarded because it is spam, junk or contains malicious content.Stronger passwords.

Windows Hello allows a computer to recognize an employee using face or fingerprint, improving user experience while reducing the likelihood of brute force password attack.Multi-factor authentication. Stolen or reused passwords, as in the Colonial Pipeline attack, take advantage of poorly configured remote access solutions that do not use multifactor authentication.Software and operating system patching. An automated, AI-driven approach for vulnerability management enables the application of patches and fixes more rapidly.User education. The end user is often the weakest link when it comes to cybersecurity, and that is what attackers are counting on.

End user security and awareness training is an inexpensive and effective way to reduce incidents.Aimee Cardwell will explain more in the session "Ransomware. Today's Threat Landscape." It's scheduled to air from 12:25-12:45 p.m. ET on Monday December 6.Twitter. @SiwickiHealthITEmail the writer.

Bsiwicki@himss.orgHealthcare IT News is a HIMSS Media publication..