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A Balance of Trust: New Guidelines for Business Associates Under HIPAA

trusted partner seal business associate guidelines

The relationship between a covered entity and business associate requires a delicate balance of trust. This balance of trust works because each is invested in the security and protection of personal health information. As a covered entity, it is important to partner with business associates that have a strong security posture with safeguards and controls in place to prevent HIPAA violations and fines.

As a covered entity, there is a heavy responsibility to know how your trusted business associates are using and protecting ePHI. To help better distribute the responsibility between a covered entity and business associate, an update was made to the Final Rule to outline the responsibilities of a business associate and their liable.

On May 24, 2019, the Department of Health and Human Services Office of Civil Rights released a fact sheet that, “Provides a clear compilation of all provisions through which a business associate can be held directly liable for compliance with certain requirements of the HIPAA Privacy, Security, Breach notification and Enforcement Rules, “HIPAA Rules.””

What changes were made?

In the new fact sheet, there are ten guidelines outlined that business associates can now be held directly liable for if a breach occurs. Below is a summary of the violations:

  1. Failure to provide records and compliance reports, cooperate with investigations and reviews, and permit access to information to determine compliance
  2. Taking retaliatory action against individuals filing a HIPAA complaint
  3. Failure to comply with the Security Rule requirements
  4. Failure to provide breach notification to a covered entity or another business associate
  5. Impermissible use and disclosures of PHI
  6. Failure to disclose a copy of PHI to the covered entity
  7. Failure to make reasonable efforts to limit PHI to minimum necessary
  8. Failure to provide an accounting of disclosures
  9. Failure to enter into business associate agreement with subcontractors that create or receive PHI, and failure to comply with the implementation specifications for such agreements
  10. Failure to take reasonable steps to address a material breach or violation of the subcontractors’ business associate agreement.

What does this mean moving forward?

Because covered entities are responsible for notifying both the Federal Government and those individuals involved in the breach caused by a business associate, it is understandable some anxiety results in trusting others with ePHI. The way a vendor handles ePHI can greatly impact goals for any healthcare organization.

Having a proper HIPAA Security Risk Analysis performed covers basic requirements on how to manage business associates for the covered entity.

More covered entities today are requiring business associates to complete a HIPAA Security Risk Analysis or data security checklist with similar policies, procedures and evidence (e.g. screenshots showing proof of encryption, firewall configuration, data loss prevention and log/alert settings) to be sent for approval prior to signing an agreement and allowing access to ePHI.

These assurances protect the covered entity, the business associate and most importantly the individual’s rights to privacy and security.

How can HIPAA One support the balance of trust?

The complexity of managing multiple business associate agreements and contracts can quickly become unmanageable. However, HIPAA One will be releasing a new tool to help healthcare organizations better manage and track, automate and update these agreements all in one place.

This new Vendor Management System (VMS) is built on HIPAA One’s existing BAA contracting software which was designed to allow healthcare providers better organize contracts and reduce the time, effort, and administrative overhead. Below are the key features of the VMS tool:

  • Automated reminders, tracking, and updates with the option to bulk upload vendor information
  • Straight forward, ready-to-use contract templates (CE-friendly). Edits are easy to perform, and all fields are pre-filled for simpicity
  • Flexible and customizable templates can be grouped by purpose or department. VMS also allows edits to existing legal contracts
  • VMS satisfies security requirement standards by requiring the business associate, vendor or recipient of the contract to upload proof of compliance prior to sending the BAA contract
  • Built-in electronic signatures file the agreements upon signing making it easy to find during audits or contract reviews. All files, communications and actions are logged automatically
  • This tool can integrate with EHR or ERP financial platforms. Additionally, in subsequent HIPAA One Security Risk Analysis, users will have their inquiries pre-filled for questions related to Business Associates

We understand that it takes a lot of trust to partner with business associates and share critical data across the continuum of care. Ensuring each vendor has a standard of security that satisfies requirements is important before allowing a BAA to be signed. If you would like to know more about our Business Associate Agreement tool, or would like to be notified when we release our Vendor Management Solution, please contact us at

HHS SRA Tool Version 3.0 – The Good, Bad and Ugly

Good Bad Ugly Blog Image

Earlier this month, the U.S. Department of Health and Human Services (HHS) and the Office for Civil Rights (OCR) released an updated version of their Security Risk Assessment Tool (SRAT). We have been following the development of this toolkit since its inception in 2011 as the HSR toolkit and reviewed V2.0 in early 2014. Each time a new version is released, HIPAA One gathers with a few trusted industry partners to review the changes and updates so that we may accurately counsel healthcare providers, payers and business associates on the pros and cons of utilizing this free, government-issued application.

Before diving into our review of V3.0, it is important to note that HHS in no way states that by using SRAT, healthcare providers are assured compliance with the Security Risk Analysis requirement under HIPAA. Per the Health website: “Disclaimer: The Security Risk Assessment Tool at is provided for informational purposes only. Use of this tool is neither required by nor guarantees compliance with federal, state or local laws.”

This is not to say that SRAT does not have its merits. At HIPAA One, we firmly believe that SRAT can be an effective training tool for compliance professionals as well as a guideline for certified auditors. Despite being a time-consuming process, SRAT does provide step-by-step instructions similar to a bona fide HIPAA Security Risk Analysis. Healthcare professionals should merely be cautioned that without the guidance of a trained auditor, SRAT may or may not hold up in an audit scenario.

The Good

In short, the newly updated Security Risk Assessment Tool (SRAT) has made improvements mainly related to the user experience and follows the HIPAA Audit Protocol and NIST-based methodologies for calculating risk. One update, although mostly a file repository, is the bulk asset upload feature. This has been added along with a multi-location option for larger entities.

ONC/HHS Report Screen

Furthermore, organizations seeking assistance with Business Associate Agreement (BAA) management will find that HHS has added a BAA-type function. However, it is important to note that this does not actually produce a BAA agreement.

Having the ability to enter asset type and status at different stages of the ePHI systems is great but, without having the ability to track or assign these questions, an inexperienced user may not be able to identify where some of the gaps came from.

As users work through the tool, they will find that questions now map back to the HIPAA citations (similar to our software). There are also “tips” added throughout the tool. That being said, the most significant update is the production of a Final Report (arguably the most crucial component in completing a risk analysis.) Much like the rest of the tool, the newly created Final Report has a flag attached as the results of this report are fairly arbitrary with a large margin of error based on how the user responds to the risk calculation.

The Bad

Although SRAT it is a free tool (albeit funded by our taxpayer dollars) and updates have been made to create a better user experience, compared to other software solutions in the market place today, the tool still falls short. We frequently use the term “free like a puppy is free”. Aside from the tool being labor-intensive, mundane and error-prone; each measure results in multiple questions that need to be individually selected by one who knows how to estimate impact and likelihood year-over-year.

SRAT takes a single-user approach which means there is no way to collaborate on the assessment with others in the organization. This approach can result in the need for additional committee meetings to oversee remediation of identified risks. Also, because there is no option to delegate survey questions to employees in different roles, you may have someone in IT trying to answer HR related questions. Lastly, should users desire to go back to a previous section or revise an answer, navigation is difficult. Past sections are merely available through <BACK> and <NEXT>.

Being that SRAT does not save any historical data related to previous assessments, organizations who have completed risk assessments in past years are unable to import their old assessments and simply make updates reflective of the past year. Healthcare providers focused on creating a sustainable and long-lasting HIPAA compliant office, should seek out a tool that allows for year after year imports to decrease the amount of administrative work in completing a risk analysis each year.

The Ugly

When evaluating the accuracy and comprehensive nature of the tool, there are a few glaring issues that we would be remiss not to address. These are the aspects of SRAT that would require either the experience of a certified auditor or compliance professional in training to ensure the assessment is completed accurately.

Some of the issues not remedied by the V3.0 update include:

  • No Calculation of Risk – Without an experienced Auditor who is qualified to answer and assess risk, the average user is required to assign a risk score to each question without guidance or training. For example, the generated gaps from the SRAT do not have a correlation or identify which HIPAA control requirement those policies need to be addressed.
  • No Remediation Planning or Guidance – One critical component to completing a risk analysis is addressing and remediating the deficiencies and findings after the fact. The remediating planning process gives providers a framework for next steps and continued compliance.
  • The Final Report – A component missing from the final report is an executive, high-level overview. Additionally, in the final report there is an inability to see if you have met partial requirements or if there is a policy that needs to be edited or changed. Lastly, there is no prescriptive recommendations for addressing any of the identified risks.
  • No Included Policies and Procedures – SRAT does not include PnP templates nor does it review any current, existing PnP’s. This leaves providers at risk for continuing to use potentially outdated PnP templates and minimizes the possibility for a yearly review of these templates.

In summary

2018 HIPAA SRAT v3.0 tool


  • Bulk asset upload
  • Multiple location option
  • Basic Business Associate Agreement (BAA) utility
  • Questions map to HIPAA citation
  • Guidance through on screen “tips”
  • Simple Final report
  • User guide


  • No specified roles. One person is left to answer questions they may not be qualified to answer, from IT to HR.
  • No auto calculation of risk. Without a certified auditor, answering and assessing risk for each of the questions is arbitrary.
  • Does not provide an actual Business Associate Agreement (BAA).
  • Navigation is difficult. Past sections are only available through <BACK> <NEXT>.
  • Lots of clicks
  • No remediation planning or guidance
  • No review by an auditor to keep impartiality. No ongoing updates
  • No policies and procedures provided or review of the providers policies. Could be older than 3 years
  • No vulnerability scan for free linking back to software
  • Graphs near the end that are not updatable and have a questionable purpose
  • No importing assessments year after year
  • Use of the SRAT tool will not guarantee you will pass an audit

Bottom line, this solution would work for compliance-in-training individuals or those who have the time but no funding to run a stand-alone SRA solution.

If your workplace is considering using the SRAT tool for your 2018 risk analysis, we would encourage you to take a look at our industry-leading automated software before doing so. At HIPAA One our software scales seamlessly based on your role and size of the organization. And with tiered pricing accessible for even single-doc physician practices, HIPAA One is the only choice for a guarantee to pass an audit using a simple, automated and affordable approach to conducting the annual HIPAA assessment.

Cloud Email Phishing Attacks: A Practical Guide

Email Phishing Blog Image Ed

Attention CIOs, CISOs and IT Administrators!

A quick review of the HHS Breaches Over 500 list paints a pretty grim picture of the number of breaches affecting 500 or more individuals. Breaches have been steadily increasing and the culprit is clear: Hacking/IT incidents, namely email phishing attacks. Fraudsters and criminals are exploiting vast databases of compromised user credentials to make payroll. These accounts are publicly available for lookup. Anyone can access these credentials and they are available for as little as $45 for 1000 account/password pair.

According to a recent Proofpoint study, 72% of all cloud users have been targeted at least once for an attack and of those, 44% were successful. That’s right, almost 1-in-2 targeted attacks were successful. This number includes organizations using Multi-Factor Authentication (MFA).

Why are these attacks so successful?

Internet Message Access Protocol (IMAP) is a legacy email protocol which is turned-on by default when email is enabled for users and is not integrated with MFA. It was originally designed to give people a way to connect via electronic mail.

Unfortunately, IMAP is being used by Hackers to test email address and password combinations to see if they can login and bypass MFA. Once they are in, they can use that same login and password to connect via VPN and gain full access into the network allowing them to forge emails and download email attachments.

In today’s Office365, IMAP is turned on by default (for backward compatibility) and unless it is needed, it must be turned off in order for MFA to be effective.

Three Steps to control email phishing attacks and more effectively use MFA

First, turn off IMAP and POP3  in Office365

  1. Launch the Exchange Administrator Console
  2. Open User Mailbox
  3. In each User’s Mailbox, go to Mail Features, scroll-down, and disable IMAP and POP3

Second, turn on Multi-Factor Authentication

  1. Go to Multi-Factor Authentication Controls
  2. Use prompts, guides or just highlight users and turn on MFA for multiple users.

Third, set passwords to never expire and require a longer, easy-to-remember but hard-to guess passphrase. You could also encourage each user to install an encrypted password program i.e. Keepass to secure and store all passwords.

By implementing the above changes, it will help comply with HIPAA Security §164.308(a)(3)(i) (Implement P&P to ensure appropriate ePHI access) and §164.312(a)(2)(i) (Assign unique IDs to support tracking) while blocking hackers from bypassing MFA. Take steps today to turn off your IMAP and POP3 and capitalize on your Office 365 and Exchange investments.

Like our blog? You can watch our webinar for an in depth look at controls you can implent today to avoid an email phishing attack: “Confessions from a HIPAA Auditor: Breaches Surge Due to Email Phishing”  

“In this webinar session, we discuss the most common data breached we see happening in the industry, namely email hacking. We explore the anatomy of an email phishing breach and how to leverage the HIPAA Security Risk Analysis to cover this threat. We also highlight three practical steps you can take to prepare for a data breach and avoid being the next target.”

State Departments Conducting Audits?!?

In recent years, healthcare audits have been a trending topic within the compliance world. Following the Phase II launch of the HHS Office for Civil Rights (OCR) Audit Protocol in March 2016, many members of the healthcare community equate audits with either the federal government or other large accounting firms such as Figliozzi & Company. All too often, providers assume that due to their size, they can fly under the radar. After all, why would OCR audit a single physician practice?!? Unfortunately, as one of our clients recently learned, it is not just the federal government that is checking on gaps in compliance or incentive program participation, state departments are getting in on the action too.

Earlier in the summer, one of our clients reached out as that they had received a letter from Connecticut’s Department of Social Services. The letter explained that due to ongoing program monitoring efforts, Connecticut’s Department of Social Services would be conducting a review of Connecticut Medicaid Electronic Health Record (EHR) Incentive Program payments made to participating providers. Per the notice, federal regulations governing the Medicaid EHR Incentive Program requires States to conduct post-payment reviews. Much to the shock of our client, they were informed they had been selected for a Program Year 2014 desk review and they had just five business days to submit the requested documentation in a PHI secure manner.

Naturally, receiving such a letter would invoke a certain amount of panic in anyone, especially when considering the Program Year in question was FOUR years ago. As you can imagine, a trail of fears and concerns ran through their minds: “Did we conduct a risk analysis that year?” “What if we are unable to produce all the documentation required for this audit?” “How do we best respond?” To protect our client’s privacy, we will not share the results of the audit, however, all providers should heed this cautionary tale if they have ever participated in past or current government incentive programs.

So, what’s the takeaway from this story? Regardless of whether you performed risk analyses every year for the past six years (per HIPAA Citation 45 CFR 164.316(b)(2)(i)) or not, it is never too late to get your house in order. Auditing bodies respond much better to providers who have performed a risk analysis at least once rather than never.  The majority of settlements and fines site either failure to have completed a risk analysis OR failure to take action on high-risk findings.

At HIPAA One, we are deeply experienced at responding to a vast array of industry audits and resolutions (now we can add State Department audits to that long list!) and frequently step in to hold our clients’ hands through the experience. One of the benefits of being a HIPAA One client is the assurance that we will stand by any HIPAA risk analysis performed using our software so your organization is not shouldering that burden alone. Contact Us today to learn more.

Healthcare Continues to Dominate Breach Related Costs

A new study conducted by the Ponemon Institute on behalf of IBM Security confirmed the fears of so many healthcare information security professionals, no other personal information yields a higher value than compromised patient records.

Across the country, healthcare organizations have a Goliath size security problem. For an eight-straight year, healthcare has the highest breach-related costs of any industry at $408 per lost or stolen record, nearly three times the cross-industry average of $148. Without a commitment to cyber-security, healthcare entities and their valuable databases containing vast amounts of electronic patient health information (ePHI) are sitting ducks for hackers.

We all know that data breaches can cost organizations millions in lost business, reputation management, recovery remediation and year over year that number is exponentially rising. In 2018, the average cost of a data breach globally is roughly $3.86 million, up 10% from 2014. The Ponemon study, 2018 Cost of a Data Breach, is an extensive compilation of data based on interviews with 500 organizations that experienced data breaches.

Along with providing staggering breach stats, the study also referenced a new category of breaches, mega data breaches which refers to the theft or exposure of more than 1 million records. The number of mega data breaches has more than doubled in the past five years from 9 in 2013 to 16 in 2017. As you can imagine, these mega breaches are both extremely costly to resolve and can take up a year to detect and contain. The average cost of a mega data breach involving a “modest” 1 million records is hovering around $40 million.

So, What’s a Provider To Do?!

The findings from this year’s breach report beg the question, how can healthcare providers across the board strengthen their individual security programs and better protect ePHI? For starters, conduct a bona fide HIPAA Security Risk Analysis (SRA.) If your organization has not completed an SRA in the past calendar year, your data is vulnerable, plain and simple. An SRA does more than just help your office collect the largest amount of MIPS/MACRA reimbursement dollars, by identifying gaps in your organization’s compliance and security settings, the SRA is an invaluable tool in securing the safety of your ePHI. There are many SRA tools out in the marketplace today ranging from free spreadsheet templates to expensive consultants, at HIPAA One, we recommend utilizing our simple, automated and affordable software.

Upon completion of your SRA, there are two additional best-practices that can greatly decease the chance of an ePHI breach due to theft, loss, improper disposal and hacking incidents. Stick with us, we’re going to get a little bit “techy” in this next section and take a deeper dive into data classification and encryption:


Despite the fact that all data does not have PHI identifiers, (e.g. name, address, any other numerical or identifying information) it is paramount to identify where the data is located within your organization.  This effort will involve working directly with the architects and programmers of your data system.

A good place for your programmers to start is by reviewing any and all data mapping and data flow diagrams. To gain further insight into what’s already been completed in this area, a thorough review of existing data cryptography or sequence database schema will be conducted. Following data cyptography, a sensitive data analysis is performed – if using external consultants to augment IT staff, there should be no hands-on access needed as long as the data flow diagram and data mapping is available. It is also important to note that these mappings can also be performed through remote workshops.

The work flow outlined above will result in a data inventory (e.g. email, name, home address and system data such as session ID’s, IP addresses, etc.).  Side note, an analysis at this point should identify any EU-citizens needed for the new GDPR mandates. Any application mapping exercise should augment the data classification by determining why a user or application would need to see information that may or may not be required for the intended purpose.  Sometimes applications will bypass database encryption and give a user excessive access to ePHI that is not necessary, opening the chances for unauthorized-access breaches.


Disclaimer: We understand that turning on global encryption to databases can be unacceptable – and we do not recommend doing this.

As a best practice, only encrypt data inside specific tables and employ best-practices for key generation, management and entry. For example, at deployment, a password is used for decryption of the master encryption key. The master encryption key is provided on a one-time  basis by a singular person (or portions of the password shared between people) who knows the password.  The master password should also be stored in RAM strictly for performance and security purposes. From an electronic media standpoint (e.g. laptops, desktops, thumb drives, smartphones, tablets, etc.), encryption of the entire hard-drive or volume is recommended. Most SSD drives (high-speed hard drives) and computer hardware come equipped with processors to handle the overhead of encryption/decryption as needed on these devices.

Next Steps

We specialize in HIPAA Security Risk Analysis and data security projects.  If your organization has not yet completed an SRA for this calendar year, Contact Us to get started today.


Similar but Different: Gap Assessment vs Risk Analysis

If you’ve heard the terms gap assessment and risk analysis used interchangeably before in privacy or security conversations, you are not alone. At HIPAA One, we have found that there are quite a few misconceptions about these two approaches and how to differentiate between them. So much so that we addressed the topic on a recent webinar with our trusted partners and advisers, Crowe Horwath. Click here for a link to the recorded version. In this post, we’ll define the key characteristics of a gap assessment and risk analysis and debunk a few myths along the way.

High-level overview slide from our webinar with Crowe Horwath 

As the more well known of the two, a HIPAA security risk analysis is a comprehensive assessment of all risks to ePHI (Electronic Protected Health Information) as required by HIPAA for healthcare providers and their business associates. By calculating risk based on threat, vulnerability, likelihood and impact, providers can gauge their compliance with HIPAA’s required administrative, physician and technical safeguards. A risk analysis assesses how ePHI is created, received, maintained and stored within an organization. Every bona fide HIPAA risk analysis will produce a remediation plan which creates a road map for “fixing” any security vulnerabilities as found by the risk analysis. For additional information and guidance on HIPAA risk analyses, visit The U.S. Department of Health & Human Services Office for Civil Rights (OCR) website.

Risk Analysis Pro

A gap assessment (also commonly called a HIPAA Compliance Program Review or Audit) is a method of assessing the differences in performance between an organization’s information systems or software applications to determine if there are any existing vulnerabilities in their network security settings. This high-level review of an organization’s controls can be completed using various controls and frameworks based on the target objectives of the gap assessment. Essentially a gap assessment compares what safeguards an organization has in place vs the reality of how well those safeguards are working.

Question within the HIPAA One software regarding Gap Assessment and the HIPAA OCR Audit Protocol

HIPAA Gap Assessment IN HIPAA One

While a gap assessment is without question an effective tool at locating vulnerabilities, OCR clearly states that that a gap assessment is never a substitute for a bona fide risk analysis as required by the HIPAA Security Rule. Think of a gap assessment as an introduction, not a replacement to a risk analysis. When facing the decision of whether your workplace should focus on a risk analysis or gap assessment, our recommendation is always to comply with HIPAA first and tackle your HIPAA risk analysis. Then, once your risk analysis has been completed and remediation has begun, HIPAA One presents the gap assessment in the final report (below). Bottom line, never put your organization at risk by not complying with HIPAA or completing a risk analysis.

At HIPAA One, we offer industry-leading, automated HIPAA risk analysis software and professional services to help your organization “check the box” on this mandatory requirement and be audit-ready. Click here to learn more and speak with a member of the team to hear about new software feature, Automated Templates which measure compliance controls at a corporate level then validating and updated by the field office staff.

GDPR and Windows 10 Compliance

This is the second post in a 2-part series on GDPR. Guest post written in collaboration with Microsoft.

On April 14, 2016, the European Union (EU) ratified the final version of the General Data Protection Regulation aka GDPR. The new GDPR regulation has been characterized as the most sweeping and impactful change to privacy and data protection regulations in history. GDPR goes into effect on May 25, 2018 with broad reaching implications for EU-based organizations and multinationals around the globe. It is critical to note that GDPR imposes new rules on organizations that offer goods and services to people in the EU or those that collect and analyze data tied to EU residents, no matter where they are located.  This means that US based healthcare covered entities and organizations defined as controllers or processors of an EU citizen’s or resident’s healthcare data will be directly affected by GDPR and must be prepared to meet these regulatory requirements.

The General Data Protection Regulation (GDPR) sets a new bar for privacy rights, security, and compliance, which will be enforced through heavy penalties. Microsoft has made the commitment that all its online services will be GDPR compliant and backed by contract, providing assurance that any of their personal info is protected and in compliance. With Privacy-by-design as a core guiding principle, Microsoft provides a comprehensive set of software services to enable customers to meet their GDPR requirements.  Microsoft recognizes that end-to-end compliance is required and must be implemented as a holistic process across the organization including (and beginning with) the protection of endpoints. Windows 10 enables organizations to begin their GDPR compliance journey.

GDPR Focus: Data Protection and Security – Not Technology

Like the HIPAA regulations, GDPR makes no direct reference to technical or technology requisites. However, GDPR does require organizations to build a holistic & structured approach to data protection and overall security.

More specifically, GDPR states the following:

(Art. 24.1) Taking into account the nature, scope, context and purposes of processing as well as the risks of varying likelihood and severity for the rights and freedoms of natural persons, the controller shall implement appropriate technical and organisational measures to ensure and to be able to demonstrate that processing is performed in accordance with this Regulation. Those measures shall be reviewed and updated where necessary,

(Art. 24.2) Where proportionate in relation to processing activities, the measures referred to in paragraph 1 shall include the implementation of appropriate data protection policies by the controller,

(Art. 28.1) Where processing is to be carried out on behalf of a controller, the controller shall use only processors providing sufficient guarantees to implement appropriate technical and organisational measures in such a manner that processing will meet the requirements of this Regulation and ensure the protection of the rights of the data subject.

Microsoft GDPR Readiness and Assessment Tool

Microsoft Windows 10 enables an organization’s GDPR security and privacy requirements with its cloud-enabled security stack that includes device protection, identity protection & management, information protection, threat detection and protection, and security management and operations. For example, beginning with the Windows 10 Anniversary Edition, Microsoft includes the Windows Information Protection (WIP) component that provides integrated protection against accidental data leaks.

With WIP Windows 10 can:

  • Protect data at rest locally and on removable storage
  • Enable corporate versus end user data to be identified wherever it rests on the device with the ability to wipe that data
  • Provide a common experience across all Windows 10 devices and prevent unauthorized apps from accessing business data and users from leaking data with copy and paste protection
  • Enable seamless integration into the Microsoft cloud platform
Additional Resources

GDPR and the Impact on U.S. Healthcare Providers

A new acronym has begun popping up within the healthcare technology community and is slowly beginning to gain momentum in the way of media coverage and industry articles. If you’ve heard the term GDPR in the past few months and did not understand what it was referring to, know that you’re not alone. In fact, we conducted a recent webinar poll with over 300 registrants and found that 81% of providers did not know what GDPR was referring to, let alone its potential impact on the U.S. healthcare industry.

Defining GDPR

GDPR stands for General Data Protection Regulation, a new set of rules drafted by the European Union (EU) to give citizens more control over their personal data. Think of a “stricter” HIPAA compliance for EU countries. Back in January 2012, the European Commission began working on plans to create data protection reform across the EU so that European countries would have greater controls in place to manage information in the digital age. Additionally, GDPR aims to simplify the regulatory environment for businesses so both European citizens and businesses can benefit from a digital economy. Fast forward six years and now in just a few short weeks GDPR will take effect internationally (May 2018.)

The Stateside Implications

The primary question we are asking ourselves at HIPAA One is how will this framework impact U.S. based healthcare providers? Here’s what we know, U.S. companies do not need to have business operations in one of the 28-member states of the EU to be impacted by GDPR. The new set of rules will require organizations around the world that hold data belonging to individuals who live in the EU to a high level of protection and must be able to account for where every bit of data is stored.

The good news is a large majority of U.S. based healthcare providers will be relatively safe in terms of complying with GDPR. If your organization is not actively marketing your services in the EU or practicing in the EU, a data breach where an EU citizen’s PHI is compromised would most likely be your most realistic brush with GDPR. For instance, a walk-clinic in New York City seeing many international tourists has a much higher chance of being impacted than say a rural clinic treating mostly local residents. Providers in larger cities with more diverse patient groups will need to be extra vigilant regarding their breach notification standards and security posture.

Controller vs. Processor

An important concept for healthcare entities to grasp when thinking about GDPR is controllers vs processors which can be defined similar to the way we view covered entities and business associates. A processor (business associate) processes data on behalf of a data controller (covered entity) and is required to protect the data just as a controller would. Much like the HIPAA regulations, GDPR requires controllers/data processes to ensure a level of security appropriate to the risk by implementing technical and organizational measures to mitigate the risk. One way that controllers or processors can demonstrate such compliance is adopting existing leading practices such as COBIT, ITIL, NIST or ISO standards.

How to Prepare

With still many unknowns about the true implications of GDPR on the American provider, there are few ways your organization can prepare now to ensure a proper level of readiness.

  • Conduct HIPAA Security and Privacy and Breach Notification Risk Analysis – The HIPAA One SRA and PRA software addresses most of the recommended GDPR controls and checks the box on an important mandatory HIPAA requirement. Double win!
  • Review your current risk governance – An evaluation of your organization’s security posture is a great step in preparing for the growing international cybersecurity climate.
  • Conduct a GDPR Assessment – Our internal research concludes GDPR encompasses approximately 60% of the same standards and regulations as OCR’s HIPAA Audit Protocol (e.g. performing a HIPAA Security Risk Analysis per 45 CFR §164.308(a)(1)(ii)(A)). A complete and comprehensive set of Policies and Procedures can be used to bridge the gap of the remaining 40% of standards covered by GDPR.

Just as we try to do with all cybersecurity and HIPAA related happenings in both the U.S. and aboard, the team at HIPAA One is committed to closely monitoring GDPR requirements and providing our readers with the most up-to-date information we have. As with all aspects of healthcare, sometimes it feels like the only constant is change. By getting your house in order now, your workplace will be well equipped to navigate any changes brought on by GDPR in the months and years to come.

Learn more about how your practice can get started with a bona fide HIPAA risk analysis today.

Cloud Security in Healthcare

Guest Blog by Yiannis Koukouras, TwelveSec in collaboration with HIPAA One

In our culture, something or someone is always trending. Whether it be bell-bottom jeans in the ’70’s, playing Nintendo in the ’80’s or watching stock market go up and down (whenever!), trends are a lenses through which we see the world. Much like trends in fashion or entertainment, our workplaces showcase various trends as well and the healthcare information technology (HIT) community is no different. Currently, organizations migrating their data to cloud based systems is a trend which shows no signs of slowing down anytime soon. The migration of healthcare records from being placed “in the closet down the hall” to the cloud, is becoming commonplace for both single doc practices and large health plans alike. The cloud allows organizations of all sizes to compete effectively in the new digital era and stabilize costs.

As this IT shift occurs, we can’t help but wonder, is Cloud Security truly secure? After all, an organization may transfer their security risks to an external provider, however does that organization understand the responsibility for safeguarding the data cannot be transferred? For example, under HIPAA/HITECH it is the responsibility of the data-owner to report the breach and assume costs even if the breach occurred by the Business Associate (45 CFR §§ 164.400-414.)

Is Your Cloud Provider Really Secure?

Currently the marketplace is saturated in cloud service providers. Public providers like Amazon Web Services (AWS), Microsoft Azure or Google cloud, dominate the landscape and offer cloud services at very competitive prices. Despite their brand recognition and reputation, do we have any assurances AWS or Microsoft Azure are secure? Is the feeling of security with these companies real or a convenient illusion?

The truth is these public providers are by-design very secure, however, they are also delicate and susceptible to common, simple and unintentional configuration errors that can lead to data leakage and/or data loss. Like safety belts in automobiles are statistically-proven to save lives, it is up to the driver and passengers to fasten before embarking on the next drive.   Within the last two years, over 1.5 million private medical records have become publicly available through Amazon Web Services due to mis-configurations on the security settings of the latter. The exposed data, impacted organizations like Kansas’ State Self Insurance Fund, CSAC Excess Insurance Authority, and the Salt Lake County Database.

Cloud Security Impacts Everyone

The common misconception is only small organizations pay little regard on Cloud Security. However, recently two stories became publicly known regarding military data exposed on the Internet. The first included “dozens of terabytes” of social media posts identifying and profiling persons of interest for the U.S. Intelligence, while the other one, included a classified toolkit for potentially accessing U.S. military intelligence networks. Both examples were found on an open Amazon-hosted data silo, due to misconfigured access rights.

A large number of other data leakage stories have also made headlines recently including major international players like Accenture, Verizon and Viacom. All of these stories have the same underlying theme, the affected companies where all placed in the awkward position of having to comment on misconfigured cloud accounts. These data breaches revealed that every cloud deployed solution is not bullet-proof and can only be as safe as their privileged users / administrators (the weakest link of this chain) allow them to be.

In an attempt to address cases like the aforementioned misconfigurations, in the 4th quarter of 2017 Amazon announced new security features and safeguards. These new features, which include data encryption and user warnings when data is publicly accessible, are a step in the right direction. However, due to the fact that cloud services become more and more complex with new features added every day, no one can solely rely upon these new features to secure their cloud infrastructure.

Tip of the Iceberg

Due to the fact these cases were discovered on large public cloud providers, like AWS, Microsoft Azure and Google cloud, one can easily assume that any organization regardless of size is at risk. As IT professionals, we can only speculate about the cloud security vulnerabilities of private cloud environments as not many cases have been analyzed in the international literature. In private cloud systems, functionality is prioritized over security. Irrelevant but interdependent configurations are to be sorted out in limited amount of time, using different and possibly incompatible software vendors. These characteristics showcase just some of the potential misconfiguration threats for the confidentiality of your data in private cloud storages.

It is important to remember that all the aforementioned risks, are placed on healthcare providers while they try to remain HIPAA compliant and does not take into any account the usual risks imposed for all online content. Negligent user activity or becoming a target of cyber-criminals remain a valid risk that requires urgent mitigation.

Cloud Security in Healthcare

Whether public or private, all cloud systems should be tested in order to identify vulnerabilities in an effort to become “cyber-proof.” Any exposure of sensitive data heavily impacts the image and reputation of healthcare providers. Cloud security testing is truly a necessity and should be implemented from the very first day your organization begins saving sensitive data on a cloud system. After weighing the cost of a data exposure, the value of investment in external IT security services absolutely increases.

At TwelveSec and HIPAA One, our group of certified consultants can offer your organization a thorough assessment of your cloud systems’ security posture. By identifying gaps and vulnerabilities that may harm your enterprise and customer data, we are able to work together to secure your systems and address the following:

  • Assess the security of your cloud infrastructure,
  • Review your cloud security policies and
  • Test your cloud Applications against unauthorized usage.

As a team at HIPAA One, we understand through first hand experience Platform-as-a-Service security concerns.  Contact us today for a free application security consultation to find the most effective way to assure the risks of unauthorized access to your organization’s data are minimized.

Missed your SRA in 2017? Here’s How to Avoid a MIPS Penalty

First, do your HIPAA Security Risk Analysis immediately to reduce chances of a breach while maintaining compliance with all Federal reimbursement programs. With just mere days left before the March 31st MIPS submission deadline, if you have not already pulled together the necessary documentation for the previous calendar year, it is the time to do so! For all those last “minute’ers,” we have some guidance to assist in your efforts.

One of the most important concepts to understand about the 2017 MIPS program is the grace that is being extended by CMS.  In fact, 2017 is being considered a “transitional year” meaning providers do not need to have all three measurements in place to avoid penalties and gain incentives – GOOD NEWS! As a reminder, these measurements include: Quality Measures, Advancing Care Information (security risk analysis required) and Improvement Activities.

“Some key information on the process of submission is included in the Data submission fact sheet  and a Merit-based Incentive Payment System (MIPS) data submission video.” – CMS Division of Health Information Technology

Additionally, if the provider is in an Alternative Payment Model (APM) group, CMS broke down the groups below:

For Shared Savings Program Participants

“ACOs in the Shared Savings Program submit quality measures to the CMS Web Interface on behalf of their participating providers and MIPS eligible clinicians.  The Shared Savings Program measures and corresponding benchmarks will also be used to determine the MIPS quality performance category score for all MIPS eligible clinicians in each ACO. Therefore as long as your ACO submits all of the required Shared Savings Program Web Interface measures, then you do not need to report the MIPS quality performance category separately.”

For Next Generation ACO Model Participants

“ACOs in the Next Generation ACO Model submit quality measures to the CMS Web Interface on behalf of their participating clinicians.  The Next Generation ACO measures and corresponding benchmarks will also be used to determine the MIPS quality performance category score for all MIPS eligible clinicians in each ACO.”

For All Other MIPS APMs

“Under the Quality Payment Program, the APM Entity group in these APMs will not be required to report  quality in the first MIPS performance period.  This does not change any CMS requirements to report quality measures as part of your participation in the APM.”

A few important FYI’s related to penalties:
  • To Avoid the 4% Penalty – Providers must submit something, at least one item from one of the measurements listed above
  • To Avoid the Penalty and ATTEMPT to Earn a Positive Payment Adjustment – Providers can participate partially and CMS determines payment based on what is submitted
  • To Avoid the Penalty and RECEIVE a positive payment adjustment – Providers will need to participate for the full year and complete all measurements
  • If No Participation or Action is Taken – A 4% penalty will be applied

In the event your workplace did not conduct a HIPAA security risk analysis in 2017, you can still avoid the 4% penalty by submitting something from the other measurement categories (Quality or Improvement Activities.)

Finally, there is no time like the present to complete a bona fide HIPAA Security Risk Analysis! Checking this box will immediately reduce your changes of a breach while maintaining compliance with all Federal reimbursement programs. Get started today!