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Washington Debrief: Cybersecurity Information Sharing Grants Available from HHS

August 1, 2016
by Leslie Kriegstein, Vice President of Congressional Affairs, CHIME
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Cybersecurity

Cybersecurity Information Sharing Grants Available from HHS

Key Takeaway: Two grants have been made available by the Department of Health and Human Services (HHS) to improve information sharing on cybersecurity threats within the Healthcare and Public Health (HPH) Sector.

Why it Matters: Two divisions of HHS, the Office of the National Coordinator (ONC) and the Assistant Secretary for Preparedness and Response (ASPR), have announced grant opportunities to further cybersecurity information sharing efforts. HHS hopes these opportunities will facilitate the sharing of cybersecurity threats identified in the HPH Sector with relevant stakeholders in the industry as well as federal partners, including the U.S. Department of Homeland Security (DHS) and the Federal Bureau of Investigation (FBI). The Funding Opportunity Announcements released by ONC and ASPR can be renewed for up to five years and call for an existing ISAO or Information Sharing and Analysis Center (ISAC) to:

  • Provide cybersecurity information and education on cyber threats affecting the (HPH) Sector
  • Expand outreach and educational activities to assure that information about cybersecurity awareness is available to the entire HPH Sector
  • Equip stakeholders to take action in response to cyber threat information
  • Facilitate information sharing widely within the HPH Sector, regardless of the size of the organization

Details are outlined below:

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  • ONC grant:
    • Applications due: August 19
    • Grant amount: $250,000
    • Eligible to apply: Among the types of entities that can apply are public and private non-profits and entities already providing outreach and technical assistance to participating organizations on cyber threats
  • ASPR grant:
    • Applications are due: August 25
    • Grant amount: $150,000
    • Eligible to apply: Nonprofits with a 501(c)(3) status other than higher education institutions

Meaningful Use

CMS Announces Cardiac Bundling Program – Contains IT Requirements

Key Takeaway: CMS has published a proposed regulation on bundling cardiac care.

Why it Matters: CMS’ recently published rule proposes to implement three new Medicare Parts A and B episode payment models targeting care for Medicare fee-for-service beneficiaries receiving services during acute myocardial infarction, coronary artery bypass graft and surgical hip/femur fracture treatment episodes. All related care within 90 days of hospital discharge will be included in the episode of care. This program would apply to care beneficiaries receiving care in acute care hospitals in certain selected geographic areas.

Pursuant to the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), there are two pathways for physicians to be reimbursed beginning in 2019; the Merit-Based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs). CMS has proposed that in order for episode payment models (EPMs) to meet the criteria to be Advanced APMs, EPM participants would have to use Certified Electronic Health Record Technology (CEHRT) and meet financial risk requirements to be in Track 1 of each EPM. CMS has also proposed that those in EPMs who are not using CEHRT would be in Track 2 and thus not qualify for being an Advanced APM. CMS has proposed similar requirements for the Comprehensive Care for Joint Replacement (CJR).

OIG Report Details EHR Downtime

Key Takeaway: The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has published a new report, “Hospitals Largely Reported Addressing Requirements for EHR Contingency Plans,” examining the downtime of electronic health record (EHR) systems.

Why it Matters: Federal agencies and Congress continue to evaluate potential impacts on patient safety resulting from EHR downtime, whether it result from internal hardware disruptions or cyberattacks. Most recently OIG published a report which they described doing because, “Disruptions, such as natural disasters or technical malfunctions, can make electronic health records (EHRs) unavailable to hospital staff. Prior OIG work found, for example, that hospitals experienced substantial challenges responding to the effects of Superstorm Sandy, which included damage to health information systems and curtailed access to patient medical records. More recently, cyberattacks on hospitals have similarly prevented or limited access to EHRs.”

In studying the issue, OIG found that almost all hospitals have written EHR contingency plans and that approximately two-thirds said they addressed the four Health Insurance Portability and Accountability Act (HIPAA) requirements reviewed by the OIG, including: a data back-up plan, a disaster recovery plan, an emergency-mode operations plan and testing and revision procedures.

OIG concluded that the growth and evolution of threats to digital health information validates the need for EHR contingency plans. Further, OIG reinforced their prior recommendation that the Office for Civil Rights (OCR) implement a permanent audit program for HIPAA compliance.

Members of Congress, including Representative Ted Lieu (D-CA-33) and Will Hurd (T-TX-23), cited concerns about EHR downtime and specifically questioned potential patient safety implications of ransomware events in a recent letter to the OCR.

Patient Safety

FDA Clarifies Regulation of Wellness Products

Key Takeaway: The Food and Drug Administration (FDA) has published new guidance on “general wellness” products.

Why it Matters: Much to do has been made recently over whether a wellness product must undergo formal approval from the FDA. As companies try to navigate an increasingly complex regulatory landscape, the FDA has been pressured to publish guidance to help better understand when a product is required to be cleared by the agency. To that end, the FDA published guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” and welcomes comments per the notice in the federal register.

According to the FDA, the guidance is intended to, “provide clarity to industry and FDA staff on … compliance policy for low-risk products that promote a healthy lifestyle (general wellness products).” The FDA adds they hope the guidance will improve the “predictability, consistency, and transparency” of the agency’s oversight of these products. For purposes of the guidance, the FDA says “general wellness products" are products which “are intended for only general wellness use as defined in the guidance and present a low risk to the safety of users and other persons.”

Members of Congress have urged the FDA not to impede innovation in health IT through overregulation, thus legislation in both the House and Senate has been introduced to clarify the FDA’s role in the regulation of health IT products. Representative Marsha Blackburn (R-TN-07) initially authored the Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) Act (SOFTWARE Act) in 2013, and given the continued interest in this topic, the proposal was included in the 21st Century Cures Act (H.R. 6), which passed the House last July. Similarly, Senators Michael Benett (D-CO) and Orrin Hatch (R-UT) have introduced the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, which was approved by the Senate Health, Education, Labor and Pensions Committee in April to offer a slightly different perspective on where the FDA should step into regulate health IT products. A comparison of the legislative proposals, the SOFTWARE Act and MEDTECH Act, can be found here.

Interoperability

President Signs Comprehensive Opioid Abuse Bill into Law, Includes Directive to Integrate PDMPs and EHRs

Key Takeaway: On July 22, President Obama signed the Comprehensive Addiction and Recovery Act of 2016 into law, which included a direction for grant recipients to integrate Prescription Drug Monitoring Program (PDMP) Data into electronic health record (EHR) systems.

Why It Matters: The law directs states to encourage the incorporation of the latest technological advances available for the integration of PDMP data directly into the workflow of prescribers, which includes the need for interoperability with EHRs. The states receiving the $10 million in grant funding must report on interoperability with health information technology systems such as electronic health records, health information exchanges, and e-prescribing, and whether or not the state provides automatic, up-to-date or daily information about a patient when a practitioner requests information on a patient.


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Targeting Third Party Risk: Leading CISOs Detail Efforts to Secure the Healthcare Supply Chain

December 18, 2018
by Heather Landi, Associate Editor
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Healthcare information security leaders are faced with the dauting challenge of securing information systems and data at a time when the cyber threat landscape is evolving rapidly and becomingly increasingly complex.

Most patient care organizations’ supply chains are filled with third parties who support the care delivery process and require access to patient information. Properly vetting and monitoring these third parties is a major challenge, and in some cases, insurmountable for many organizations who simply don’t have the expertise or resources, according to healthcare IT security leaders.

Many healthcare chief information security officers (CISOs) have found that effectively assessing the security posture up and down the supply chain is expensive given the complexity of the risks posed by privacy and security concerns, as well as an everchanging regulatory landscape. Currently, the process of managing third-party risk is often inefficient and time-consuming, for both vendors and providers, while still leaving organizations vulnerable to security threats.

During a recent webinar, sponsored by HITRUST, focused on healthcare cybersecurity and managing third party risk, John Houston, vice president, privacy and information security at the 40-hospital UPMC health system in Pittsburgh, outlined a number of factors that have made third-party risk management increasingly challenging and complex.

“There has been a fundamental change in IT, and a rapid move to the cloud. At the same time, we all see an increasingly complex cyber threat landscape where the threats are more sophisticated, and the technology solutions are more sophisticated as our business requirements are changing. It’s an increasingly complex landscape,” Houston said.

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He further noted, “As a result, there is a lot of confusion about how we best ensure our information is secure and available, and what is reasonable in terms of trying to achieve that. And finally, we are all worried about risk, and the biggest risk is patient safety. We worry about the cost of litigation and penalties, but first and foremost, we need to think about ensuring that we are able to deliver the best care to our patients.”

The stakes are changing, Houston noted, as federal regulators are investigating and penalizing organizations for failure to monitor third parties’ security practices, and hackers are increasingly targeting medical devices, he said.

“From a CISO perspective, we need to ensure that we are applying proper oversight over all of this. We can’t assume third parties are doing the right thing,” he said.

What’s more, healthcare organizations are increasingly reliant on cloud technology. A year ago, Nuance Communications, a provider of voice and language tools, was knocked offline when the company was hit with the Petya ransomware virus.

“I was around during Y2K, and about 95 percent of all our applications at UPMC, we ran within the data center, on premise. About 95 percent of newly acquired applications were run on on-premise, there was little on the cloud. In that environment, it falls upon the entity to secure data within its possession,” he said.

Contrast that with today’s environment, as Houston noted that “very little of what we acquire today runs on-premise. In some way, shape or form, at least one copy of the data is in the cloud.”

Studies have estimated that by 2023 no more than 25 percent of applications will be run on-premise in an organization’s data center, with about 75 percent run in the cloud, Houston said. “Many copies of our data end up in the cloud, and it’s not just one cloud provider. We get services from a lot of different vendors, all of which are in the cloud. That speaks to the fact we, as CISOs, can no longer directly secure our own information. We are dependent upon third parties to secure our data for us. We can’t simply trust that they are going to adequately secure that information.”

From a healthcare CISO’s perspective, a vendor’s IT and data security practices should be at least as effective as the provider’s security posture, Houston said. “I should expect nothing less. As soon as I expect less, that’s a sign of defeat.”

Across the healthcare industry, ineffective security, compliance and assurance methods drive cost and confusion within organizations and across third parties.

While most healthcare organizations are taking the right steps to monitor and screen vendors and their products and services during the pre-selection and on-boarding phases and are also conducting security risk assessments, it’s still not enough to protect IT systems, data, and, most importantly, patients, said Taylor Lehmann, CISO at Wellforce, the Burlington, Mass.-based health system that includes Tufts Medical Center and Floating Hospital for Children. “We are still seeing breaches, and the breaches are still coming after we do all this screening,” he said.

“We’re not being effective and it’s difficult to be effective with the current paradigm,” Houston added.

From the CISO’s perspective, there are inefficiencies in the third-party supply chain ecosystem. Suppliers are commonly required by their customers to respond to unique questionnaires or other assessment requests relating to their risk management posture. Vendors often must fill out questionnaires with 300-plus questions. What’s more, there’s no assurance or audit of the information the vendor provides, and the process is completely inefficient for suppliers who are audited 100 times annually on the same topics, but just different questions, And, the security assessment often occurs too late in the process.

“We’re creating a lot of waste; we’re taking time away from our organizations and we’re taking time away from suppliers,” he said. “The current way we’re doing supply chain risk management, it doesn’t work, and it doesn’t scale, and there is an opportunity to improve.”

To address these issues, a group of CISOs from a number of healthcare organizations established the Provider Third Party Risk Management (TPRM) Initiative to develop a standardized method to assess the risk management posture of third-party suppliers to healthcare firms. Launched this past August, the founding member organizations for the Provider TPRM Council include Allegheny Health Network, Cleveland Clinic, University of Rochester Medical Center, UPMC, Vanderbilt University Medical Center and Wellforce/Tufts University. Working with HITRUST and PwC, the Council aims to bring uniformity and consistency to the process while also reducing the burden on providers and third parties.

The healthcare industry, as a whole, will benefit from a common set of information security requirements with a standardized assessment and reporting process, Lehmann noted.

In the past four months, the governing members have been expanded to include Nuance, The Mayo Clinic, Multicare, Indiana University Health, Children’s Health Dallas, Phoenix Children’s Hospital, and Banner Health.

The Provider TPRM initiative is increasing membership and gaining momentum as security leaders from both healthcare providers and their suppliers embrace the unified approach, Lehmann said.

One of the goals for the Council is to address the inefficiencies found in the third-party supply chain ecosystem. By reducing the multiple audits and questionnaires, the financial savings will allow business partners to invest in substantive risk reduction efforts and not redundant assessments, the Council leaders say.

“By reducing wasted effort and duplication, suppliers will find their products and services will be acquired more quickly by healthcare providers. This will also reduce the complexity of contracts and provide third parties with better visibility regarding the requirements to do business with providers,” said Omar Khawaja, VP and CISO of Allegheny Health Network and Highmark Health. Khawaja’s organization is a founding participant and governing member of the Provider TPRM initiative.

As part of this initiative, going forward, provider organizations that join the effort will require third-party vendors to become HITRUST CSF Certified within the next two years, by September 2020. The HITRUST CSF Certification will serve as the standard for third parties providing services where they require access to patient or sensitive information and be accepted by all the Council’s organizations. HITRUST CSF is an industry privacy and security framework that is continuously evolving with the changing cyber landscape.

 “After September 1, 2020, third parties without certification cannot do business with participants,” Khawaja said.

Houston added, “We recognize that there are limitations in our current processes, and what we’re putting in place is at least as good or better than what we’re already doing. This will lead to faster onboarding, less waste, better transparency, and simpler compliance.”

By choosing to adopt a single comprehensive assessment and certification program, healthcare organizations represented by the council are prioritizing the safety, care, and privacy of their patients by providing clarity and adopting best practices that their vendors can also adopt, while providing vendors the expectation of what it takes to do business with their organizations.

“It provides transparency,” Houston said “It sends a message to suppliers that we’re an open book about what it takes to do business. That’s powerful.”

Moving forward, the Provider TPRM initiative will focus on adding business associates to the effort to increase membership and impact, Lehmann said. “The simple fact is, many of us are pushing this through our supply chain and there are organizations that may not have a process or low maturity process. But, through the efforts of council members, more suppliers will show up, which is means safer products are possible to purchase.”

Further, the program will likely develop additional requirements on vendors such as breach response and monitoring security threats and alerts observed as third-party vendors.

The Council also plans to focus on certification programs for smaller vendors. “A lot of innovation in healthcare is coming from smaller companies, and we understand there is a gap between what those companies can do with respect to cyber. We’re not lowering our standards, but we want to be thoughtful and create a certification program for those areas. We want to do business and we need a vehicle to bring them in in a safe and secure way,” Lehmann said.

“We want to build a community of health providers working together, business associates working together, to share information,” Lehmann said. “We want to better inform ourselves and align other programs, like cyber insurance, to enable more effective planning throughout the supply chain. The things we learn through these relationships can translate to other aspects of our organizations.”


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Florida Provider Pays $500K to Settle Potential HIPAA Violations

December 12, 2018
by Heather Landi, Associate Editor
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Florida-based Advanced Care Hospitalists PL (ACH) has agreed to pay $500,000 to the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) to settle potential HIPAA compliance failures, including sharing protected health information with an unknown vendor without a business associate agreement.

ACH provides contracted internal medicine physicians to hospitals and nursing homes in west central Florida. ACH provided services to more than 20,000 patients annually and employed between 39 and 46 individuals during the relevant timeframe, according to OCR officials.

Between November 2011 and June 2012, ACH engaged the services of an individual that claimed to be a representative of a company named Doctor’s First Choice Billings, Inc. (First Choice). The individual provided medical billing services to ACH using First Choice’s name and website, but allegedly without the knowledge or permission of First Choice’s owner, according to OCR officials in a press release published last week.

A local hospital contacted ACH on February 11, 2014 and notified the organization that patient information was viewable on the First Choice website, including names, dates of birth and social security numbers. In response, ACH was able to identify at least 400 affected individuals and asked First Choice to remove the protected health information from its website. ACH filed a breach notification report with OCR on April 11, 2014, stating that 400 individuals were affected; however, after further investigation, ACH filed a supplemental breach report stating that an additional 8,855 patients could have been affected.

According to OCR’s investigation, ACH never entered into a business associate agreement with the individual providing medical billing services to ACH, as required by the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules, and failed to adopt any policy requiring business associate agreements until April 2014. 

“Although ACH had been in operation since 2005, it had not conducted a risk analysis or implemented security measures or any other written HIPAA policies or procedures before 2014. The HIPAA Rules require entities to perform an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of an entity’s electronic protected health information,” OCR officials stated in a press release.

In a statement, OCR Director Roger Severino said, “This case is especially troubling because the practice allowed the names and social security numbers of thousands of its patients to be exposed on the internet after it failed to follow basic security requirements under HIPAA.”

In addition to the monetary settlement, ACH will undertake a robust corrective action plan that includes the adoption of business associate agreements, a complete enterprise-wide risk analysis, and comprehensive policies and procedures to comply with the HIPAA Rules. 

In a separate case announced this week, a Colorado-based hospital, Pagosa Springs Medical Center, will pay OCR $111,400 to settle potential HIPAA violations after the hospital failed to terminate a former employee’s access to electronic protected health information (PHI).

Pagosa Springs Medical Center (PSMC) is a critical access hospital, that at the time of OCR’s investigation, provided more than 17,000 hospital and clinic visits annually and employs more than 175 individuals.

The settlement resolves a complaint alleging that a former PSMC employee continued to have remote access to PSMC’s web-based scheduling calendar, which contained patients’ electronic protected health information (ePHI), after separation of employment, according to OCR.

OCR’s investigation revealed that PSMC impermissibly disclosed the ePHI of 557 individuals to its former employee and to the web-based scheduling calendar vendor without a HIPAA required business associate agreement in place. 

The hospital also agreed to adopt a substantial corrective action plan as part of the settlement, and, as part of that plan, PSMC has agreed to update its security management and business associate agreement, policies and procedures, and train its workforce members regarding the same.

“It’s common sense that former employees should immediately lose access to protected patient information upon their separation from employment,” Severino said in a statement. “This case underscores the need for covered entities to always be aware of who has access to their ePHI and who doesn’t.”

Covered entities that do not have or follow procedures to terminate information access privileges upon employee separation risk a HIPAA enforcement action. Covered entities must also evaluate relationships with vendors to ensure that business associate agreements are in place with all business associates before disclosing protected health information. 

 

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Eye Center in California Switches EHR Vendor Following Ransomware Incident

December 11, 2018
by Rajiv Leventhal, Managing Editor
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Redwood Eye Center, an ophthalmology practice in Vallejo, Calif., has notified more than 16,000 patients that its EHR (electronic health record) hosting vendor experienced a ransomware attack in September.

In the notification to the impacted patients, the center’s officials explained that the third-party vendor that hosts and stores Redwood’s electronic patient records, Illinois-based IT Lighthouse, experienced a data security incident which affected records pertaining to Redwood patients. Officials also said that IT Lighthouse hired a computer forensics company to help them after the ransomware attack, and Redwood worked with the vendor to restore access to our patient information.

Redwood’s investigation determined that the incident may have involved patient information, including patient names, addresses, dates of birth, health insurance information, and medical treatment information.

Notably, Redwood will be changing its EMR hosting vendor, according to its officials. Per the notice, “Redwood has taken affirmative steps to prevent a similar situation from arising in the future. These steps include changing medical records hosting vendors and enhancing the security of patient information.”

Ransomware attacks in the healthcare sector continue to be a problem, but at the same time, they have diminished substantially compared to the same time period last year, as cyber attackers move on to more profitable activities, such as cryptojacking, according to a recent report from cybersecurity firm Cryptonite.

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