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Cybersecurity: New Area for Mobile Medical App Compliance, Part 1
February 2, 2016 11:41 AM by Silas Gossman

[Editor’s Note: this blog was originally written by Andy Miller]

A two-part series examining regulatory compliance to raise awareness around cybersecurity risks.

Regulatory compliance. While this phrase may strike an ominous tone for many traditional mobile app software companies, it is familiar territory for veterans in the mobile medical app space. It is unlikely the software developers behind the first calorie counting app gave regulatory compliance much thought. Applications, after all, have been a source of convenience, entertainment and education for years. However, as mobile apps have grown more integrated and mobile device sensor technology has become more sophisticated, that calorie counting app may be transformed into a tool for treating obesity, diabetes and sleep disorders. Smart software developers have come to realize that mobile medical apps are a way to future profits as well as a benefit to patients.

That is where the regulatory compliance piece of the puzzle comes in. We are all now familiar with the FDA and their Guidance on Mobile Medical App regulation, issued this past February. In my opinion, the guidance leaves far too many apps essentially unregulated. However, it does corral the applications posing the greatest patient risk and provides app developers with a pathway to obtain clearance before being marketed.

However, simple regulatory compliance is only part of the picture. Providing assurance of mobile medical application security is as essential to delivering a safe and effective product as is functional and performance testing. What good is a mobile medical app if it cannot upload health information to its central server securely? What if the app is compromised, leading to a breach of patient health information? Or even worse, what if an app is subject to hacking, and as a result the patient medical device it connects to can be somehow manipulated? Now we are speaking of actual patient harm.

Some potential cybersecurity risks to medical devices include:

-          Breaches of protected health information

-          Stolen financial information and identity theft

-          Loss of device availability at a time of need

-          Compromised device performance and malfunctions

-          Theft of device intellectual property

My intent is not to scare anyone, but rather, raise awareness. App developers likely rely on clinical and technical experts to ensure they have mitigated risk and met their functional and performance requirements. The question becomes whether or not these developers have analyzed the cybersecurity risks posed by, and to, their applications. The FDA requires that cybersecurity be addressed in 510(k) filings, but like much of the agency’s guidance, the requirement is described at a high level. It is left up to the app developer to essentially self-police based on an analysis of cybersecurity risks – and therein lies the problem.

[Editor’s Note: this blog was originally written by Andy Miller]

A two-part series examining regulatory compliance to raise awareness around cybersecurity risks.

Regulatory compliance. While this phrase may strike an ominous tone for many traditional mobile app software companies, it is familiar territory for veterans in the mobile medical app space. It is unlikely the software developers behind the first calorie counting app gave regulatory compliance much thought. Applications, after all, have been a source of convenience, entertainment and education for years. However, as mobile apps have grown more integrated and mobile device sensor technology has become more sophisticated, that calorie counting app may be transformed into a tool for treating obesity, diabetes and sleep disorders. Smart software developers have come to realize that mobile medical apps are a way to future profits as well as a benefit to patients.

That is where the regulatory compliance piece of the puzzle comes in. We are all now familiar with the FDA and their Guidance on Mobile Medical App regulation, issued this past February. In my opinion, the guidance leaves far too many apps essentially unregulated. However, it does corral the applications posing the greatest patient risk and provides app developers with a pathway to obtain clearance before being marketed.

However, simple regulatory compliance is only part of the picture. Providing assurance of mobile medical application security is as essential to delivering a safe and effective product as is functional and performance testing. What good is a mobile medical app if it cannot upload health information to its central server securely? What if the app is compromised, leading to a breach of patient health information? Or even worse, what if an app is subject to hacking, and as a result the patient medical device it connects to can be somehow manipulated? Now we are speaking of actual patient harm.

Some potential cybersecurity risks to medical devices include:

-          Breaches of protected health information

-          Stolen financial information and identity theft

-          Loss of device availability at a time of need

-          Compromised device performance and malfunctions

-          Theft of device intellectual property

My intent is not to scare anyone, but rather, raise awareness. App developers likely rely on clinical and technical experts to ensure they have mitigated risk and met their functional and performance requirements. The question becomes whether or not these developers have analyzed the cybersecurity risks posed by, and to, their applications. The FDA requires that cybersecurity be addressed in 510(k) filings, but like much of the agency’s guidance, the requirement is described at a high level. It is left up to the app developer to essentially self-police based on an analysis of cybersecurity risks – and therein lies the problem.

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Innovating at the Intersection of IT and Care
January 26, 2016 11:58 AM by Silas Gossman

[Editor’s Note: this blog was originally written by Jonathan Draper]

Breaking down the silos between data sources and departments involves a complex blend of technology and people that, not surprisingly, can result in conflict along the way. However, the ultimate goal remains the same for all: protect the patient. Understanding the concerns of each department and encouraging communication amongst the groups can reduce this tension, allowing for innovation1 to take hold and enhance care throughout an organization.

For example, consider the implementation of mobile platforms across a health system. In the past, IT departments deployed and rolled out the technology–in a way, forcing physicians into it without giving them a say in the matter. As the bring your own device (BYOD)3 trend gained traction, physicians began to demand the ability to have access and leverage mobile technology, similar to their peers in other industries. This was a scary thought for hospital IT departments that had to think about not only their own systems, but also how physician behavior might affect security. It took time for the trend to become a norm; but more importantly, it required the IT team to acknowledge that mobility is a permanent healthcare tool – not just another temporary Band-Aid or fad–while care teams had to prove the value of this access while showing they could manage this power responsibly. These realizations, in conjunction with the benefits (providing improved access to information), give everyone a common goal and common direction to work toward.

This shift to a collaborative understanding also means that innovators need to be able to deliver features that are tailored to both audiences–the IT department and the physicians. It’s a delicate balance in focusing on the usability features that physicians are looking for, while also making sure that the solution is deployed in a way that adheres to IT department policies. 

For an innovator, having the ability to understand both of these worlds is vital in merging them together and bringing technology trends to a nuanced market. Bringing only a physician’s perspective reduces the likelihood that you understand emerging trends that are proving worthwhile in other tech-focused fields and that will need reshaping to fit a healthcare need. On the other hand, if you’re only looking at things from a technology/IT perspective, you may not realize what the healthcare need is in the first place to build something caregivers are actually willing to adopt!

As innovators seek to balance these worlds, they should take inspiration from four key areas:

 

  1. Industry Issues: Knowing which regulations, buzzwords or pain points keep popping up puts innovators at the forefront of addressing problems on the horizon – before anyone else sees them coming.
  2. Competition: As an extension of industry trends, it is key to know what competitors (including vendors and leading health systems) are offering customers (who could be patients!).
  3. Market Development: Both in healthcare and IT, “hot breakthroughs” should help guide developments to address key pain points and drive efficiency, usability and access to information.
  4. Regulatory: Staying informed on regulatory approaches and issues worldwide can position you as a leader in terms of protecting and investing in patients and their data. Particularly for global technology, it is critical to make sure that you have the appropriate features and follow the expected standards to ensure that your product can be accredited globally.

As mobility has demonstrated, the traditional means of care can benefit greatly by leveraging technology. By working with both IT and caregivers, innovators can make this a reality.

Jonathan Draper is the Director of Product Management, Healthcare at Calgary Scientific. Jonathan directs the product roadmap and works closely with healthcare partners and institutions globally to develop innovative solutions that address clinical needs and meet the technical requirements of healthcare enterprises.

References:
1. Pratt, Nancy. “Navigating the Sea of Innovation: Targeting the Right Audience with the Right Tools.” Mobile Health Matters. October. http://mobilehealthmatters.com/2015/10/13/navigating-the-sea-of-innovation-targeting-the-right-audience-with-the-right-tools/
3. BYOD Definition: http://whatis.techtarget.com/definition/BYOD-bring-your-own-device

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5 Questions to Ask Your Next Risk Adjustment Partner
January 15, 2016 8:10 AM by Silas Gossman

[Editor’s note: this blog was originally written by Steve Whitehurst]

As the availability of healthcare data continues to grow, many new technologies for risk adjustment are entering the market. When thinking about adopting a new risk adjustment solution, plans should conduct a realistic self-evaluation in addition to also considering the support capabilities and workflow expertise of their potential partners.

It’s important to understand your own risk adjustment organization’s readiness in order to determine the best external approach for your needs. In particular, a look at your overall performance, operations, and infrastructure is vital to understand which partners will best fit your team’s characteristics. You should have a full understanding of where your current risk scores are, outstanding opportunities, staffing levels, data acquisition processes, etc. to get a baseline of your overall maturity and sophistication. A reputable partner will have expertise and processes to help with this step. 

Once you have a good understanding of your status quo, it will be easier to consider where outside support is warranted. Most vendors love to pontificate on their solution, so we recommend you probe on their support, industry expertise, and overall workflow adaptability in order to ascertain their overall fit with your operations. Here are a five key areas to explore:      

1.            What are the improvement opportunities that are present in my organization? This involves not only the quantification of risk capture potential, but also an understanding of where in the risk adjustment ecosystem the opportunities exist. This allows for meaningful prioritization of the opportunities.

2.            What is the best method of improvement to address these opportunities? Retrospective review, prospective campaigns, provider education, billing staff education, member outreach, etc. – depending on the type of opportunities that exist, the appropriate method for improvement may vary. This is critical to maximizing the ROI.

3.            Is my organization ready to implement the proposed methods? If not, what are the gaps and how can I close them? The best methods will not work if there aren’t enough coding resources or if the appropriate data isn’t available. Together with the solutions partner, the readiness gaps need to be addressed before moving forward. A vendor with the best interest of the customer will not want to implement a solution without a readiness check.

4.            What is a reasonable timeframe in which we can expect to see results? Organizations can often have unrealistic expectations on how long the newly implemented solution will take to demonstrate performance improvements. Establishing measurable goals with specific timelines will help to attribute tangible ROI of the solution for leadership while maintaining engagement from key stakeholders and users.

5.            What processes will be in place to ensure improvements are continuously sustained? The biggest value of a technology-enabled solution is scalability. But if implemented without sustainable processes, improvement gains will be short-term, or your reliance on partner services will continue to incur costs. It is essential that there is a sustainability strategy aligned with your organizational needs.

Technology is only as good as the user. In a world as complex as risk adjustment, it is even more critical that technology solutions are deployed to fit the specific needs of its stakeholders. When considering a new solution, organizations should ensure that a potential partner’s people and processes, in addition to the technology, are well-aligned with your strategy. 

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Politics, Privacy and Pulling the Trigger
January 11, 2016 2:34 PM by Silas Gossman

By ADVANCE for Health Information Professionals

On Monday, January 4, 2016, President Obama spoke to the nation, as expected, and issued an executive order regarding gun safety and measures he feels will help to curb what he called the “epidemic of gun violence.”

His address was heartfelt, emotional and — predictably — polarizing. Conservatives panned what they perceived to be an overreach and an attack on the Second Amendment, while liberals lauded the president taking action where Congress hadn’t. Both sides conceded that the enhancement on background checks would not have affected or prevented recent mass shootings such as the tragedy in San Bernardino.

One of the more sweeping, lesser noted aspects of the executive order’s proposal was its enabling mental health providers a simpler way to disclose information to National Instant Criminal Background Check System (NCIS). Billed largely as a way to prevent suicides — which account for about two-thirds of all annual gun deaths in America, according to the CDC — it was noted by Healthcare Informatics that “… the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a final rule, which takes effect next month, removing legal barriers preventing states from reporting relevant information to NICS.”

This idea of removing the legal barriers put in place by HIPAA has actually been a few years in the making, according to Politico’s Morning eHealth report.

“The idea initially came three years ago in the wake of the Newtown, Conn., shootings, but has been languishing. The 1993 Brady law disqualified certain people from buying guns, including individuals involuntarily committed to mental health care and those found incompetent to stand trial or otherwise deemed to be a danger to themselves or others. But HIPAA prohibited providers from sharing the information with the FBI’s National Instant Criminal Background Check System. The rule, which takes effect next month, changes that.”

The complete text of the rule can be found at https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-33181.pdf

The overarching question is whether or not this amendment of HIPAA will prove to be problematic. While the United States government in the 21st century has consistently found itself infringing upon privacy and civil liberties in the name of security — NSA, anyone? — it is, as Healthcare Informatics senior editor, Rajiv Leventhal put it, “ … an issue that can certainly become very fuzzy.”

Leventhal continued, citing a blog post from Mental Health America, which stated, “ … what the rule says is this: (1) a firearms control data center housed in a HIPAA-covered entity can share limited demographic information with the national registry; and (2) a HIPAA-covered entity that is participating in a judicial proceeding to determine that a person cannot lawfully have a firearm (such as ordering an involuntary commitment) can share limited demographic information with the registry.”

Mental Health America’s CEO, Paul Gionfriddo added, “This change will affect a relatively small number of people (maybe in the hundreds, maybe in the thousands). So why does it matter? It has already been determined that it is illegal for the individuals whose names will be added to the list to own or possess firearms. So this might prevent a tragic event without infringing on the rights of anyone who can possess firearms.”

Ultimately, Leventhal agrees in his analysis that this is both a targeted, specific change that will not wrongfully affect the wrong people — and that privacy for those individuals should not supersede public safety. “Indeed, while the patient-provider relationship is one that should certainly be respected, it is more important to potentially save lives by providing these mental health records to the people who need them,” he said.

While the more libertarian-leaning among us may raise an eyebrow at statements like that — and more conspiratorial sorts would note that nothing is explicitly stopping the administration from tweaking or changing HIPAA further to expand this information disclosure to more patients with mental health issues, it’s certainly a topic that has the American people talking and has smart people working around the clock to address.

The president’s executive order takes aim at the gun violence problem. Time will tell if he hits the mark.

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Health IT in 2016: Where are we headed?
January 8, 2016 8:23 AM by Silas Gossman

By Betsy Jones, EBSCO Health

Health IT took some big steps forward in 2015, as more mobile and cloud platforms came online, providing easier access to patient records and clinical support resources. The health data interoperability discussion significantly advanced this year as well, with the Office of the National Coordinator for Health IT unveiling its 10-year interoperability roadmap.

While it might take a decade to achieve the deep health data interoperability the ONC envisions, healthcare already enjoyed some early benefits in 2015, as physicians and caregivers began pulling patient information from wearables, phones and other electronics to provide them with real-time analysis of their patients’ conditions.

With 2016 just around the corner, our trend-spotting physician editors and researchers have come up with five predictions for what they see happening in 2016: 

1. Physician practice consolidation will bring greater access to content:  Hospitals and health systems are buying up more privately owned practices than ever, it seems, to fulfill ACO participation goals. While some in healthcare aren’t sure this consolidation is positive, there is a silver lining: Physicians typically gain access to more sophisticated EHRs, including a subscription to integrated clinical content that enables more accurate, efficient patient care.

2. Evidence-based quality standards will continue to gain traction: Practices are tasked with improving care in order to share in incentives in new payment models. We predict that evidence-based quality measures will gain traction in the healthcare as payers and providers alike look for ways to improve the health of their patients, especially those with chronic diseases.

3. There will be an increase in the amount of Certified Medical Assistants: Meaningful Use Stage 2 states that only credentialed medical assistants are permitted to do order entry for electronic patient records; CMAs will take on entering more documentation and providing physicians with reference information to determine care plans. It’s more critical than ever that the industry include CMAs as part of the clinical team accessing valuable clinical information and decision support tools.

4. Physicians will work to consistently assess and consider patient risk: In order to reduce healthcare costs, physicians will aim to consistently use overall risk prediction and absolute risk estimates for individual patients to guide decision-making. They should forego the practice of chasing and treating for lab test values without considering the overall absolute risk to the patient.

5. Patient-Physician Communication will improve: Now more than ever, patients are expected to take on more responsibility for their care, both in co-pays and care decisions. To facilitate more patient engagement, providers will have to better explain diagnoses—what they know and what they don’t—along with treatment options, to help patients participate in this shared decision-making process. 

As technology continues to be adopted into the world of healthcare, physicians, hospital executives and decision makers will find novel applications of these new software tools to improve care. The already fast-paced world of healthcare will find new efficiencies brought on by technology, enhancing patient care by providing physicians with quick access to the information and resources they need at the point of care.

Betsy Jones is vice president of medical product management and chief content officer, EBSCO Health

 

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NLRB Regulations: Healthcare Organizations Need to Act
January 4, 2016 11:04 AM by Silas Gossman

[Editor’s Note: this blog was originally written by Jim Trivisonno, President of IRI Consultants]

Mounting success along with precedent-setting standards that ease a union’s ability to organize will contribute to a continued focus by unions on organizing hospitals and healthcare providers, further challenging employers. Employers will need to focus efforts to maintain positive employee relations and responsiveness to employee concerns.

So, to help healthcare organizations better understand where unions are focusing efforts (and in turn put plans in place to combat the issues), IRI in conjunction with the American Society for Healthcare Human Resources Administration (ASHHRA) recently published the 45th Semi-Annual Labor Activity in Health Care Report. The report shows data and analysis of national, regional and state representation and election petitions, as well as articles about relevant and timely labor issues impacting employers and the workplace. A few of the gravest issues are outlined below.

Increased Number of Petitions
From April 14, 2015, when the NLRB’s expedited election rule went into effect, through August 30, 2015, there was a 9.6% increase in the number of petitions filed to represent employees in all industries versus the number of petitions filed during the same period in 2014. The Board conducted 365 representation case (RC) elections in those few months. The vast majority were held in 21 to 30 days while the shortest petition-to-election timeframe was eight days.

On Track for Record Success
In the first six months of 2015, there were 153 representation (RC) elections held in the healthcare sector. Unions were elected as a result of 76% of these. If the rate of organizing continues, unions are on pace to file a record number of RC petitions in the healthcare industry this year.

Watch-Out States
New York, California, Michigan, Pennsylvania, Washington and New Jersey were the most active states for union organizing in healthcare. Unions continue to succeed in RC elections in these states in a disproportionate number.

Face-to-face with these facts, now more than ever, employers need to take proactive steps to prepare their organizations for a union organizing effort. Due to the new election rules that took effect earlier this year, there simply isn’t enough time for an employer to react unless they have already taken steps to think through a comprehensive, detailed prevention strategy and counter campaign.

To read the full report referenced in this blog, you may visit http://iriconsultants.com/news-article/2015-ashhra-report.

 

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Disaster Preparedness – Are We Really Confident?
December 21, 2015 8:46 AM by Silas Gossman

[Editor’s Note: this blog was originally written by Diane Hayes, president and co-founder, InCrowd]

The recent tragic events in Paris, San Bernardino or Colorado Springs lead crisis care teams instinctively to wonder “how would I handle this if it happened at my hospital?”   

The answer is concerning. Fully two-thirds of ER and critical care clinicians in the United States said they didn’t feel their hospitals were prepared to handle the victims of the next terrorist attack or other mass casualty event, according to an instant snapshot taken on November 24, 2015, several days after the Paris terrorist events.  

The microsurvey, compiled by InCrowd, a provider of real-time market intelligence to life sciences and healthcare firms, asked US ER and critical care physicians and ER and critical care nurses from its Crowd of 1.8 million global clinicians about the operational readiness of their respective hospitals.  Respondents rated readiness on a scale of 1 to 5, with 1 and 2 being “I strongly agree” and “I agree” respectively, to their confidence in preparedness, and ranked and rated other key aspects of disaster response.

The findings highlight specific areas of operational readiness where staff harbored concerns:

- Only 32% strongly agreed or agreed that their hospital had adequate staff to mobilize in a similar situation to the attacks that occurred in Paris in November. 

- Only 41% strongly agreed or agreed their hospital was ready to respond to the victims of a similar terrorist attacks. Available beds (only 26% believed they were sufficient) and adequate blood supply (only 32%) were the top concerns.  

- Surgeon availability is paramount during disasters, yet only half of the respondents felt their facility would have enough surgeons on hand during a mass casualty event. Doctors in particular were concerned about this, with only 33% of them in the survey agreeing or strongly agreeing that their hospital had adequate surgical availability for such an event, compared to 56% of nurses agreeing or strongly agreeing. 

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- Additional triage staff and additional staff training top the ranks as the most needed elements for hospital readiness, at 30% and 31% respectively. However many polled were undecided about the readiness of resources and needs. 

- Only 35% strongly agreed or agreed that their facility would have enough mental health staff available during a terrorist event—despite 42% of nurses agreeing or strongly agreeing that patients who are taken to the ER recently were exhibiting higher anxiety.  

The microsurvey included 52 ER physicians and 50 ER nurses who responded in under 2 hours using InCrowd’s real-time platform.

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ACO Success Needs Robust Health IT
December 11, 2015 8:53 AM by Silas Gossman

[Editor’s Note: this blog was originally written by Jonathan Draper]

Coordinated Care Model

In early 2015, the Centers for Medicare and Medicaid Services (CMS) announced that 50% of payments will be made through alternative or value-based payment models by 2018. One way for providers to implement value-based care is through an Accountable Care Organization, or ACO, a coordinated care model initiated by the Affordable Care Act in 2010. ACOs are networks of providers, including primary care, specialty practices, hospitals, pharmacies, imaging and diagnostic centers, that come together to lower costs and deliver better care through care coordination.

The key motivation behind the ACO movement are financial incentives based on ACOs achieving both lower costs and improved quality. Experience with the ACO model has also shown that a key consideration in the success of ACOs is the ability to share and exchange patient health information.

Image Sharing Critical to Patient Care and Profitability
Sharing images, lab results and other patient data among physicians is critical for two reasons. First, it lowers costs by eliminating redundant imaging and testing. Secondly, ACOs allow patients to get care wherever they like so the ability to share information across institutions becomes a central component of coordinating patient care. Patients can use any hospital or specialist, but the primary care provider and his or her ACO is still responsible for the costs associated with those visits. Providers now have a clear incentive for tracking where patients go for care and why. To do this, they need access to an underlying health IT infrastructure that supports patient sharing and exchange.

As they seek to share and access patient with disparate organizations and systems in order to stay in step with their patients, ACOs have become more aware of barriers to data exchange. A 2015 survey by the Workgroup for Electronic Data Interchange found that most ACOs do not have tools for either sending or receiving complete patient health data in a simple and timely manner.1

Some ACOs are made up of participating groups that each their own electronic health record, for example. For these ACOs, sharing data and images to manage and coordinate care among isn’t just nice to have, it’s essential to their ultimate profitability. Images play a critical role in this information exchange. First, by sharing them ACOs save the cost of redundant imaging. Also images are critical to patient care, particularly in emergency situations. Sharing both images and other patient information is the key to ACO profitability.

References:
1. [http://www.amga.org/wcm/AboutAMGA/News/2015/20150917.aspx

 

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Customer Perspective: Five Questions with Essilor
December 9, 2015 11:36 AM by Silas Gossman

[Editor’s Note: this blog was originally posted on Trend Micro]

Essilor is the world leader for corrective lenses with offices in over 100 countries. In line with their mission to “improve lives by improving sight,” the company develops a wide range of lenses to correct and protect eyesight, from design to manufacturing.

With 55,000 employees, 22 manufacturing plants and 400 laboratories globally, the IT infrastructure landscape comprised eight data centers worldwide. Essilor aimed to modernize its data centers and transition from a physical to a virtual environment in order to reduce cost, increase efficiency and boost performance. After the transition, 80% of Essilor’s landscape is now virtualized on VMware, deploying approximately 5,000 virtual machines (VM) globally.

Tanweer Surve, director IT infrastructure shared services, Essilor, discussed with Trend Micro his company’s business challenges, evaluation process, benefits achieved and lessons learned.

Trend Micro (TM): Transitioning to a virtualized environment, what were your main challenges from a business perspective?

Tanweer Surve, EssilorTanweer Surve (TS): During our transition, a critical area we initially overlooked was “virtualization-aware security,” or a solution that can protect our data centers during the entire move to the cloud. Additionally, traditional security products are typically very resource intensive—they don’t fit the virtual and cloud world. We also needed to ensure the solution we picked met our compliance requirements, such as HIPAA and PCI. Because we were virtualizing mission critical workloads and also considering the cloud for hybrid deployments, the evaluation of risk management and compliance management was a top priority for us.

TM: What did your evaluation process for security solutions look like?

TS: When looking for solutions, we wanted a product that integrated seamlessly with our vCenter and enhanced our virtualization investments. The product needed to be easy to use and truly flexible to meet our goal. We were looking for a seamless, automated deployment process that had minimal impacts on our VMs. Once installed, we needed a proactive system that would flag potential concerns and protect the entire system as a whole—physical, virtual, and cloud.

TM: Can you tell us about the benefits you achieved?

TS: After weighing multiple options, we selected Trend Micro’s Deep Security platform. The investment was completely justified and resulted in excellent, measureable ROI. We saw substantial productivity and performance gains, with a significant reduction in potential risk. The IT team also highly valued the single platform and centralized dashboard, which resulted in a considerable reduction in administrative overhead, including reporting to help with PCI and HIPAA compliance.

TM: Many organizations are thinking of starting the journey to the cloud or have just started it. Do you have any lessons learned or recommendations to share?

TS: Often times, IT departments rely on traditional end-point security solutions to secure their virtual environments. However, I highly recommend not trying to integrate a legacy solution with a modern data center. Instead, invest in a virtualization-aware security solution to secure virtualized endpoints and servers in the data center and/or cloud. Security designed for virtual and cloud is more scalable, efficient and easier to manage than legacy approaches. Finally, make sure you have a clear vision and strategy for your transition process from beginning to end – and don’t neglect security.

 

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Telehealth and Accountable Care in 2016
November 30, 2015 8:22 AM by Silas Gossman

[Editor’s Note: This blog was originally written by Nathaniel Lacktman]

Accountable Care Organizations (ACOs) can share costs of telehealth and remote patient monitoring services among their hospitals, providers/suppliers and other ACO participants, according to federal regulations under the Medicare Shared Savings Program (MSSP) fraud and abuse waivers. In protecting these arrangements, CMS and OIG recognize how telehealth technologies and innovative care processes can help reduce costs for the Medicare program. If 2015 was the year that brought telehealth to the consumer market, 2016 may be the year of telehealth and ACOs.

The MSSP ACOs are a key component of the Medicare delivery system reform initiative designed to reduce fragmented or unnecessary care and excessive costs for healthcare services furnished to Medicare fee-for-service beneficiaries. ACO financial rewards are predicated on the ability to control costs and improve quality. One way ACOs can use telehealth to accomplish those goals includes leveraging post-discharge care to minimize the likelihood of an avoidable hospital readmission. Another approach is to direct patients to the appropriate level of triage care (e.g., urgent care center or physician office) instead of using the ED as the primary venue for unassigned patients. Some studies1 indicate up to a quarter of all ED visits are for non-emergent care, resulting in over $4 Billion of otherwise avoidable health costs. Using telehealth as an available outlet patients can use before heading to the ED is a powerful component of ACO cost- and care-management.

The mention of telehealth services among the waivers in the regulations2 confirms CMS’ and OIG’s belief that “coordinating care, such as through the use of telehealth, remote patient monitoring and other enabling technologies” is an activity reasonably related to the purposes of the Medicare Shared Savings Program and therefore is eligible for protection under one or more of the fraud and abuse waivers. One example CMS and OIG gave was a hypertensive patient using home telehealth monitoring of blood pressure. Since ACOs have already made substantial commitments to improving quality and reducing costs in a comprehensive, integrated way, they are among the most obvious beneficiaries to harness the power of telemedicine. With these new waiver provisions, CMS and OIG appear to be encouraging that ACOs strongly consider and incorporate telemedicine into their overall operations and services.

The fraud waivers and their reference to telehealth come at a perfect time for ACOs. CMS’ report on ACO quality and financial performance results in 20143 revealed that, while ACOs saved the Medicare program nearly $600 million and notably improved quality, only 27% of the 353 ACOs participating in the MSSP received any shared savings incentive payments from the government. That means, while CMS concluded ACOs did a good job in 20144, most ACOs did not perform well enough to reach their quality and cost savings benchmarks. Despite making significant investments in infrastructure and operations to create an ACO (whether Pioneer or MSSP), the majority of ACOs still need to move the needle further in order to enjoy the financial incentives of these programs.

Increasing the quality of ACO performance by increasing quality will only become more important as CMS expands its Medicare alternative payment models. CMS intends for 30% of Medicare payments to be made in alternative payment models by the end of 2016.5 That number increases to 50% by the end of 2018. Additionally, CMS seeks to have 85% of Medicare fee-for-service payments in certain value-based purchasing categories by 2016 and up to 90% by 2018. The low rate of incentive payments may come as no surprise to some, as a recent study6 revealed only 20% of ACOs currently use telehealth or telemedicine technologies in their operations. Are the 20% of telemedicine-using ACOs among the 27% who received incentive monies? That question has not been studied, but we are aware of ACOs that use telemedicine and that received incentive monies in 2014.

ACOs and telehealth providers continue to create new solutions and changes to outdated regulatory barriers to growth and innovation. ACOs that capitalize on these opportunities, and use telemedicine and remote monitoring technology, may see an improvement in their financial incentive payments at the end of the year.

Nathaniel Lacktman is a partner with the law firm of Foley & Lardner and heads its telemedicine and virtual care practice, working with hospitals, health systems, and start-ups to build telemedicine arrangements across the United States and Internationally. His practice emphasizes strategic counseling, creative business modeling, and fresh approaches to realize clients' ambitious and innovative goals. He may be reached at nlacktman@foley.com and 813.225.4127.

References:
1. http://www.rand.org/pubs/external_publications/EP20100123.html
2. https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-27599.pdf
3. https://www.healthcarelawtoday.com/2015/09/09/2014-medicare-aco-results-released-cms-asserts-success-but-few-acos-receive-payments/
4. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-08-25.html
5. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-08-25.html
6. https://www.ehidc.org/articles/418-2015-aco-survey-results-webinar 
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Bringing the Internet of Things to Healthcare
November 30, 2015 8:20 AM by Silas Gossman

[Editor’s Note: this blog was originally written by y Terry Edwards]

According to a recent report, Internet of Things (IoT) deployments in healthcare are predicted to reach $117 billion in the next five years, introducing the industry to a new level of technology that will shift the way patient care is delivered. We’re already starting to see early signs that the Internet of Things is coming to life in healthcare. Through telehealth, chronically ill patients can use monitors that automatically send vital signs to their physician via the cloud, triggering a phone call or in-person visit to the patient’s home. And this is just the beginning. While I don’t anticipate the Internet of Things to create a world where in-person interactions with clinicians aren’t needed in healthcare, I do see it as an opportunity to streamline care processes and improve coordination to deliver better patient care. 

For example, in the near future, providers may use RFID technology to do more than track medical devices and supplies, but to actually help determine a course of action. At PerfectServe, we use conditional availability to understand how to route calls, texts and other messages to clinicians based workflow. For example, we may have a situation where a surgeon is on call, but ends up going into the operating room to perform a procedure and needs to leave his smartphone outside. With RFID, we have the potential to reroute urgent calls and texts automatically as soon as he walks into a sterile environment—sending urgent messages to the next person in line based upon his practice workflow. This enables urgent messages to be triaged faster and more efficiently, and without unnecessary interruption or delay.

Wearables, too, will have a big role to play in the IoT. Right now, we are beginning to use consumer wearables to take health and fitness tracking into our own hands. As these wearables become more sophisticated (e.g., tracking body temperature, heart rate, oxygen levels, glucose and other key metrics), we’ll need to find easier ways for health practitioners to harness this enormous amount of patient data. The IoT helps make this possible by sharing data via the cloud, and triggering processes – like scheduling a visit to test for diabetes, or adjusting a prescription for cholesterol – that can help improve patients’ health. 

Stakeholders across the healthcare industry are seeing the value this will bring to patient care, as well as to the financial stability of the industry. Many clinicians see the IoT as a way to streamline their workflow, so that they can spend more of their time caring for patients. CFOs and other financial leaders understand that deploying the Internet of Things can help improve throughput and even help providers address inefficiencies within the system. Patients will also be pushing for practical and convenient use of these technologies as a way to make health a more automatic part of their daily lives.

While the IoT holds a lot of promise for healthcare, these changes won’t be without their challenges. Security will be a perennial concern, as will liability. Who will be responsible if a device malfunctions or a process fails to trigger automatically? The FDA will have to make some big decisions about how best to regulate technologies that may be coming very close to providing direct patient care.

Ultimately, the IoT gives the healthcare industry a whole new spin, and we’re just scratching the surface of where things will go with time. What other healthcare technologies or practices do you see as the IoT initiatives of the future? 

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Attaining Benefits of Aligned ACO Incentives
November 20, 2015 8:13 AM by Silas Gossman

[Editor’s Note: this blog was originally written by Steve Whitehurst]

One of the most promising aspects of ACOs is incentive alignment. Providers, payers and patients benefit through the ACO model, wherein quality of care is coordinated and improved while costs are managed — a paradigm that ultimately benefits everyone.

Unlike traditional fee-for-service systems, payers work closely with ACOs to set performance metrics; these are intended to drive the “triple aim” of cost reductions, increases in quality of care and improved patient satisfaction. Physicians are financially incentivized to meet the agreed-upon metrics, particularly with regard to managing patient populations with chronic conditions.

A major challenge to the ACO model, however, is how to achieve these goals without adding to the administrative burden for physicians. Chronic illness management requires clinical and administrative tools for documenting and tracking the treatment and coordination activities. There are a lot of care management solutions in the market that are designed for use by physicians at the point of care — but full compliance of such solutions requires navigation out of the EHR and into other systems. The logins and back-and-forth generate extra work that busy clinicians are often not able to accomplish.

The hurdles don’t stop there. Many performance targets for quality of care and cost reductions are dependent on data related to chronic illness management — yet the most relevant data for these cases is found in physician documentation, lab results, patient-reported entries from personal health records, admission/discharge papers and other unstructured data sources. These sources are difficult to access and track, which often results in inaccurate or unrealistic measurements and targets.

As ACOs and payers are finding, alignment itself isn’t enough. Practical and attainable improvement opportunities in care management must be easily identified, tracked and pursued. Fully realizing these objectives requires technology that is just now emerging.

In the current system, physicians see patients and the billing staff applies appropriate diagnosis and procedure codes on claims. These codes heavily impact how the data is interpreted when setting the performance metrics for population management. However, evidence of chronic illnesses documented in clinical notes never enter these workflows, which means they are not factored into the relevant metrics.

Many payers believe the answer to the situation is to code better — but most provider offices code in a way that is useable primarily for billing purposes. Only a small subset of providers are willing to spend the additional time and effort required to translate clinical documentation into information that payers can use. Payers and providers are not effectively aligned in the language they speak.

Fortunately a new wave of solutions is becoming available to not only provide better measurement of patients with chronic illnesses, but also ease the burden on coding workflows. First, sophisticated healthcare-specific natural language processing (NLP) technology is being used to capture and extract insights from unstructured data. That information is then added to data repositories for analysis. This process allows population management metrics to be more accurately measured, which better reflects the health status of the membership and enables better establishment of performance benchmarks. It also allows targeted care plans to be created and implemented for specific populations.

Next, workflows are being integrated in the electronic medical record that encourage physician participation and circumvent the problem found in existing physician engagement tools. By highlighting indications related to chronic illness in the EMR, physicians are able to not only complete clinical documentation faster, but also contribute to population management in a more streamlined manner. This improved workflow results in better tracking and execution of care management activities.

Accurate performance management is a necessity in order to support the core principle of the ACO model: pay for performance. Capturing complete data at the point of care is essential, as is being able to easily share the findings of that data with other risk-sharing entities. By using the technologies now available, ACOs can not only understand their gaps in care, but also realize the full potential of their incentives to improve population-based care while maintaining a positive financial outcome.

Steve Whitehurst is chief executive officer of San Mateo, California-based Health Fidelity.

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Navigating the Sea of Innovation
November 12, 2015 7:55 AM by Silas Gossman

[Editor’s Note: This blog was originally written by Nancy Pratt, COO, AirStrip]

We are currently at a crossroads in the healthcare industry. Executives are working overtime to try to figure out how to connect and integrate data to best support clinical practice and patient care management. With health systems concerned about balancing both needs, they now need to figure out how to leverage data to get the best value out of their investment. Improvement and innovation in technology are slowly but surely enhancing the industry, but health systems are constantly being assaulted with software companies trying to sell them something. Thus, healthcare executives are left with the eternal question: Which pieces fit together best to create value and improve patient care?

One of the biggest challenges in making these types of decisions is the relative lack of individuals who understand not only clinical practice, but also operations and IT. This is a unique set of skills, and few cross all three boundaries. As a result, health systems often try to put people with different combinations of this skill set in a room together to make vital decisions.

These challenges, combined with the surplus of technology options, make it extremely difficult for health systems to overcome the solution/application overload. For healthcare IT innovators to succeed in this type of environment, they should consider the following:

Understand the problems: Executives are more willing to listen to the potential benefits of a software solution if it is directed at problems they are actively looking to address. For example, if a health system is interested in implementing a mobile strategy and they know they need to get mobile applications, they’re going to look at companies offering mobile solutions across the board. It is vital for companies to know what health systems are looking for and what problems they’re trying to solve – each department is still trying to solve their own daily problems, but there are higher level issues that health systems are trying to address as well. If you’re not addressing what they need, the solution isn’t going to make an impact.

Know the day-to-day: When creating technology, it is important to know and target whoever is using it – the needs of a physician or nurse will affect how they use a solution or tool. For example, nurses often go on “road trips” within the hospital, transporting patients from one unit to another, which often means long periods of time with other floor nurses watching their patients. Monitors located in hallways alerting nurses to patients who need help aren’t beneficial if the nurse is on a different floor without access, or busy caring for another patient at the bedside. Forcing nurses to run and check another alarm is a disservice to both patients. Being able to understand the day-to-day of care teams is vital to solving the problems they face.

Simplify workflow: A compelling workflow solution is vital. If you sell a software solution at a corporate C-suite level and it doesn’t help improve the workflow of care teams, you won’t get the adoption you’re looking for among employees. One of most important qualifications for successful adoption is workflow improvement. Without this, the technology is bound to fail.

With any healthcare industry innovation, it is vital to keep the focus on solving these issues first, before tackling anything else. Doing so will lay the groundwork for success. 

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Benefits of Aligned ACO Incentives Require Better Measurement
November 6, 2015 3:11 PM by Silas Gossman

[Editor’s Note: this blog was originally written by Steve Whitehurst]

 One of the most promising aspects of ACOs is incentive alignment. Providers, payers and patients benefit through the ACO model, wherein quality of care is coordinated and improved while costs are managed — a paradigm that ultimately benefits everyone.

Unlike traditional fee-for-service systems, payers work closely with ACOs to set performance metrics; these are intended to drive the “triple aim” of cost reductions, increases in quality of care and improved patient satisfaction. Physicians are financially incentivized to meet the agreed-upon metrics, particularly with regard to managing patient populations with chronic conditions.

A major challenge to the ACO model, however, is how to achieve these goals without adding to the administrative burden for physicians. Chronic illness management requires clinical and administrative tools for documenting and tracking the treatment and coordination activities. There are a lot of care management solutions in the market that are designed for use by physicians at the point of care — but full compliance of such solutions requires navigation out of the EHR and into other systems. The logins and back-and-forth generate extra work that busy clinicians are often not able to accomplish.

The hurdles don’t stop there. Many performance targets for quality of care and cost reductions are dependent on data related to chronic illness management — yet the most relevant data for these cases is found in physician documentation, lab results, patient-reported entries from personal health records, admission/discharge papers and other unstructured data sources. These sources are difficult to access and track, which often results in inaccurate or unrealistic measurements and targets.

As ACOs and payers are finding, alignment itself isn’t enough. Practical and attainable improvement opportunities in care management must be easily identified, tracked and pursued. Fully realizing these objectives requires technology that is just now emerging.

In the current system, physicians see patients and the billing staff applies appropriate diagnosis and procedure codes on claims. These codes heavily impact how the data is interpreted when setting the performance metrics for population management. However, evidence of chronic illnesses documented in clinical notes never enter these workflows, which means they are not factored into the relevant metrics.

Many payers believe the answer to the situation is to code better — but most provider offices code in a way that is useable primarily for billing purposes. Only a small subset of providers are willing to spend the additional time and effort required to translate clinical documentation into information that payers can use. Payers and providers are not effectively aligned in the language they speak.

Fortunately a new wave of solutions is becoming available to not only provide better measurement of patients with chronic illnesses, but also ease the burden on coding workflows. First, sophisticated healthcare-specific natural language processing (NLP) technology is being used to capture and extract insights from unstructured data. That information is then added to data repositories for analysis. This process allows population management metrics to be more accurately measured, which better reflects the health status of the membership and enables better establishment of performance benchmarks. It also allows targeted care plans to be created and implemented for specific populations.

Next, workflows are being integrated in the electronic medical record that encourage physician participation and circumvent the problem found in existing physician engagement tools. By highlighting indications related to chronic illness in the EMR, physicians are able to not only complete clinical documentation faster, but also contribute to population management in a more streamlined manner. This improved workflow results in better tracking and execution of care management activities.

Accurate performance management is a necessity in order to support the core principle of the ACO model: pay for performance. Capturing complete data at the point of care is essential, as is being able to easily share the findings of that data with other risk-sharing entities. By using the technologies now available, ACOs can not only understand their gaps in care, but also realize the full potential of their incentives to improve population-based care while maintaining a positive financial outcome.


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Same-Sex Marriage: Critical Next Steps for Healthcare Employers
November 2, 2015 7:56 AM by Silas Gossman

[Editor’s Note: this blog was originally written by Annette A. Idalski and Joan M. McCallum]

Debate will continue in the political sphere about the U.S. Supreme Court's groundbreaking June 2015 decision recognizing same-sex marriage, but healthcare employers need to set aside opinions and get to work revising their policies to comply with the law.

The court's decision in Obergefell v. Hodges found that same-sex couples have a constitutional right to marriage. All states must allow same-sex couples to marry and must recognize such marriages performed in other states.

Here are some of the areas where healthcare employers must adjust their policies and train employees.

Patient Privacy
Same-sex spouses now have the same rights to patient information and access to their spouse and their spouse’s children that always were accorded to opposite-sex spouses.

Previously, there was confusion on this issue. The Department of Health and Human Services (HHS) had issued guidance on HIPAA disclosure that said same-sex spouses should be treated the same as opposite-sex spouses in privacy matters. However, the HIPAA guidance did not override contradictory provisions of state law in those states that did not recognize same-sex marriages.

Employers in those states that did not recognize same-sex marriage must now change their patient privacy policies and HIPAA forms to conform with the law.

Family and Medical Leave
Same-sex married couples are covered by the Family and Medical Leave Act (FMLA) and are entitled to up to 12 weeks of unpaid leave to care for a spouse.

Discrimination and Harassment
The Supreme Court's decision didn't address discrimination, but a recent directive by the Equal Employment Opportunity Commission (EEOC) holds that sexual orientation can be the basis for a discrimination complaint.

Title VII of the Civil Rights Act of 1964 does not prohibit discrimination on the basis of sexual orientation, and it's likely the issue will play out in the courts. In the meantime, the EEOC has signaled that it may litigate these cases. Employers should be proactive and forbid sexual orientation discrimination and harassment.

Health Insurance 
Same-sex spouses are now entitled to health insurance and other benefits if they are offered to opposite-sex spouses. Employers should plan for the financial impact.

Surrogate Decision Makers
A patient’s spouse usually is recognized as the primary person authorized to make healthcare treatment decisions. Previously, same-sex spouses often were denied this right. Staff should be trained on the fact that same-sex spouses can now make healthcare decisions.

Birth and Death Certificates
Birth and death certificates must not exclude same-sex spouses. Obviously, this creates the possibility of confusion. California has addressed this by no longer referring to a "mother" and "father" in birth certificates; rather, it refers only to "parents."

More changes likely will follow in the months ahead and healthcare providers should begin making changes to their protocols and employee handbooks.

Annette A. Idalski is chair of the Employment and Labor Group in the Atlanta office of Chamberlain Hrdlicka.

Joan M. McCallum is an attorney in the Labor and Employment Group in the Atlanta office of Chamberlain Hrdlicka.
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