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Does Your HIPAA Risk Analysis Tool Protect Your Practice?

Posted on December 15, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Fourth quarter signifies more than a countdown to the holidays, many healthcare organizations are met with the realization that it is time to complete HIPAA risk analysis in order to comply with MACRA – MIPS. Of course, HIPAA risk analyses are nothing new, practices should be conducting  them regularly,  in light of the HIPAA Omnibus Rule which gave teeth to the regulations and made  an annual HIPAA risk analysis a requirement for every healthcare organization.

Recently, I was recently reading a blog post by HIPAA One called “Not All Risk Analysis Tools Created Equal” and it made me think about the requirements for a bona fide risk analysis. I realize that HIPAA One provides a risk analysis solution and therefore, approaches the conversation as a vendor would, however, they are also deeply embedded in the HIPAA risk assessment world and have a unique understanding of what’s happening.

I’ve seen first-hand the principle they describe in the post with many medical practices. Most medical practices are so overwhelmed  with the daily grind of dealing with staff issues, schedules, billing, supplies, etc that it’s hard for them to distinguish between a high quality risk analysis tool and one that was built 3 years ago and hasn’t been updated since then.

In HIPAA One’s blog post they offered a list of what you should look for in a HIPAA risk analysis solution and I think this is a great  starting point for any organization that needs a tool or is evaluating their existing tool:

  1. Industry-Certified Auditors on Staff – Verify the vendor has:
    1. Auditors who are certified professionals, such as CHPS, CISSP, HCISPP, CISA, etc. and
    2. Previous experience responding to AND PASSING government and private-sector audits.
  2. Compliance Gap-Assessment – This assessment determines if your workplace meets each of the HIPAA requirements as selected the Office for Civil Rights’ (OCR) HIPAA Audit Protocol.
  3. Mock-Audit – Put your money where your mouth is. If your workplace maintains HIPAA compliance, prove it with proper supporting documents and examples per the OCR’s HIPAA Audit Protocol.
  4. Risk Analysis –Bona Fide security risk analysis which digs into any non-compliant areas along with a calculation tool that addresses which gaps are low, medium or high risk to the organization using NIST-based methodologies (i.e. at minimum NIST800-30 rev1 and NIST 800-53 rev 4).
  5. Remediation Plan – This documented plan answers the questions: “Who will do what by when” in regards to remediating gaps in compliance.
  6. Final Report – Key deliverable proving compliance with HIPAA security risk analysis.
  7. Ongoing Tracking – Track the resolution of those gaps in compliance by proving due diligence in the event of an audit.
  8. Periodic Re-evaluation – Each year take a new “snapshot” performing steps 2-6 on any changes that happened from the previous year.

The item on this list that I see fall short in many solutions and services on the market today is the remediation plan. It’s amazing how many tools only account for a risk analysis, and do not provide any guidance on creating remediation plans for any risks you find. That’s a big deal and could leave you in trouble if your practice is ever audited and hasn’t remediated any of your security deficiencies .

The good news is that HIPAA risk analysis tools have come a long way over the years. ]  Much like you need to make sure EHR vendors are updating and improving their systems to meet your needs and comply with changes in government regulations, the same is true with HIPAA risk analysis tools. Make sure you take the time needed to ensure the quality of the tools and services you’re using. Ignorance is not bliss when a HIPAA audit occurs.

Note: HIPAA One is a Healthcare Scene sponsor.

Slow Learners Teach Big Lessons – $2 Million State HIPAA Penalty

Posted on December 4, 2017 I Written By

Mike Semel is a noted thought leader, speaker, blogger, and best-selling author of HOW TO AVOID HIPAA HEADACHES . He is the President and Chief Security Officer of Semel Consulting, focused on HIPAA and other compliance requirements; cyber security; and Business Continuity planning. Mike is a Certified Business Continuity Professional through the Disaster Recovery Institute, a Certified HIPAA Professional, Certified Security Compliance Specialist, and Certified Health IT Specialist. He has owned or managed technology companies for over 30 years; served as Chief Information Officer (CIO) for a hospital and a K-12 school district; and managed operations at an online backup company.

Editor’s Note: We’d like to welcome Mike Semel as the latest addition to the Healthcare Scene blog team.  We’ve been working with Mike for quite a while as a guest blogger, so it’s great to have Mike now covering security and privacy with us in a more formal capacity.  Check out all of Mike Semel’s EMR and HIPAA blog posts.

I think it is fair to call people slow learners if they get caught violating HIPAA:

  • after they published 50,000 patient records to the Internet for a 2-year period, so patients Googling themselves found their medical records,
  • and THEN DID IT AGAIN DURING THE INVESTIGATION for the first incident.

Duh.

On November 22, California Attorney General Xavier Becerra announced a $2 million settlement with Cottage Health System and its affiliated hospitals for violating both state and federal privacy laws. The settlement came after two separate data breaches where more than 50,000 patient records were made publicly available online. The state settlement is on top of a $4.125 million class-action settlement with its patients, that Cottage Health’s insurance company is trying to recover, because it said Cottage Health was not truthful on its insurance application.

It’s bad enough that from 2011 until 2013 (after it was notified by a patient that he found his medical records online), Cottage Health had a server with protected health information that was not encrypted, password protected, protected by firewalls, or protected against unauthorized access.

What is truly stunning is that, in 2015, during the federal investigation for the first incident, Cottage Health reported that it made another 4,596 patient records available online.

I have been the Chief Information Officer in a hospital, and know how bad executive and departmental management and oversight would have to be to create an environment where that can happen once, let alone twice.

Based on the complaint provided by the California Attorney General, there are a lot of lessons you can learn from this penalty.

LESSONS

1. It not just the OCR. This HIPAA penalty was issued by a state Attorney General. The federal HITECH Act (2009) gave state AG’s the authority to enforce civil penalties for violations of the HIPAA Privacy and Security Rules. It doesn’t take the federal Office for Civil Rights to go after you. It could be your state Attorney General, who is probably motivated by wanting to impress voters for his campaign to be governor or senator someday.

2. Know your state laws. California’s Confidentiality of Medical Information Act and Unfair Competition Law were also cited in the penalty. Forty-eight states, plus DC and Puerto Rico, have their own laws protecting Personally Identifiable Information. Some, like California, have state laws that protect medical records beyond the scope of HIPAA. State laws have different patient notification requirements than HIPAA’s maximum of 60 days. In California, patients must be notified within just 15 days.

3. Management should pay attention to security and compliance, before it has to sign $6 million in checks, plus legal fees. From the IT department to the executive suite, this penalty is proof that management was not validating the organization’s security and compliance.

Cottage Health isn’t a small, rural hospital with 25 beds, trying its best, with limited resources, to serve a community. According to its 2016 Annual Report, Cottage health generated over $746 million in revenue and had 3,120 employees.  Seventeen of them are Vice Presidents.

At least Cottage Health’s CEO didn’t publicly blame his IT guy, like the former CEO of Equifax did in front of Congress. Maybe he realizes he could have avoided spending $6 million by having better management.

4. Patients are Consumers, who are protected against Negligence & Unfair Business Practices. The $4 million settlement plus the $2 million penalty are proof that management was ignoring the commitment it made to its patients every day in the Cottage Health Notice of Privacy Practices.

Our Pledge
We understand that medical information about you and your health is personal, and we are committed to protecting it.

The Federal Trade Commission forced the closure of a small medical lab because it said the lab violated its prohibition of Unfair Business Practices by not protecting patient information.

There is a lawsuit in Connecticut where the state appeals court certified a Notice of Privacy Practices as a contract with a patient.

Yes, patients (and now their lawyers) really do read those notices. Treat yours with respect because it is a contract, not a brochure.

5. Don’t Assume Your HIPAA Compliance Program is Working. Not having policies, procedures, basic IT security like passwords and firewalls, means that a lot of Cottage Health managers and executives had to be asleep at the switch. Not complying with the HIPAA Security Rule, effective since 2005, which protects electronic data, means that Cottage Health’s compliance program was a mirage. I can imagine their compliance and security staff telling management that they had everything handled. Management believed them. Over 50,000 patients and an Attorney General disagree.

6. Prevent the Triggering Event. This wildfire started with a small spark. An IT engineer configured a server and plugged it into the network. Things as simple as checklists could have prevented the negligent publication of the medical records to the Internet.

The NIST Cybersecurity Framework (NIST CSF) is a 41-page document simple enough for even small organizations to use to improve their data security.

Bring in a qualified independent third party to evaluate your compliance and security against the HIPAA rules and the NIST CSF, and give the report directly to the CEO. Not a good use of the CEO’s time? It’s much better than the CEO’s involvement after an investigation has started.

7. If You Are Being Investigated, Don’t Let the Same Problem Happen Again. Duh.

HIPAA May be the Least of Your Compliance Worries

Posted on November 21, 2017 I Written By

The following is a guest blog post by Mike Semel from Semel Consulting.  Check out all of Mike Semel’s EMR and HIPAA blog posts.

What requirements have you hidden away?

I visited a new healthcare client last week, and asked if anything in particular made them call us for help with their HIPAA compliance. They surprised me by saying that their insurance company had refused to sell them a cyber-liability/data breach insurance policy, after they saw the answers on our client’s application.

When was the last time you heard about an insurance company not selling a policy? That’s like McDonalds looking you over, and then refusing to sell you a Big Mac.

Our client was scared that they would have to risk the full financial burden of a data breach, which, based on the number of medical records they have, could exceed $10 million.

Everyone knows that HIPAA is a compliance requirement. But it isn’t the only one you should focus on. Use my definition of Compliance, which is, simply, having to do things required by OTHERS.

We personally deal with compliance requirements all the time. We stop at traffic lights. We have our car inspected. We fasten our seat belts. We empty our pockets at airport security. We pay our bills on time. At work, we wear an ID badge, show up on time, and park in an approved space. At home, we take our dirty shoes off before walking on the carpet. There are risks associated with NOT doing each of these things.

It can be a big mistake to focus so much on HIPAA that you forget other compliance requirements, including:

  • Other Federal and State Laws
  • Industry Requirements
  • License Requirements
  • Contractual Obligations
  • Insurance Requirements
  • Lawsuits

You should not take the narrow HIPAA approach, like buying a policy manual, using an online ‘We Make HIPAA Easy’ service, or think hiring out a Security Risk Analysis is going to make you compliant.

When we work with our clients, before we get started we help you identify all your compliance requirements.

OTHER FEDERAL REGULATIONS

Depending on the services you offer, you may be required to comply with other federal regulations, like Title 42, governing substance abuse treatment.

The Federal Trade Commission has come down hard on data breaches, including the controversial closure of a small medical lab. The FTC looks at patients as consumers, and considers a data breach to be an Unfair Business Practice because the organization losing the data failed to protect its consumers, and is in violation of its Notice of Privacy Practices.

STATE LAWS

Forty-eight states, plus DC and Puerto Rico, have data breach laws. Most states protect Personally Identifiable Information (PII), including driver’s license and Social Security numbers. Some states cover medical records, no matter who has them, while HIPAA only covers medical records held by certain types of organizations. Some of the state laws change the reporting requirements after a breach of patient records. For example, California requires patient notification within 15 days, instead of the 60-day maximum permitted by HIPAA.

Most states have separate laws requiring confidentiality of mental health, HIV, substance abuse, or STD treatment records. State attorneys general are willing to cross their state lines to protect the confidentiality of their voters.

We work with our clients to identify the states where your patients come from, not only where you are located. We build an Incident Management program that includes each applicable notification and reporting requirement.

INDUSTRY REQUIREMENTS

Industry requirements include PCI-DSS, the data security standards protecting credit card information. PCI stands for the Payment Card Industry. While not a law, if you don’t comply with PCI you can be prevented from accepting credit cards. What would that do to your bottom line and patient satisfaction?

LICENSING

Licensing requirements protecting patient confidentiality go back long before HIPAA, which became law in 1996. In 1977, 19 years before HIPAA, I became an Emergency Medical Technician (EMT). The first class I took was about maintaining confidentiality. After that, I knew that violating a patient’s confidentiality could cost me my license.

Think about your license, your certifications, even the Code of Ethics in your professional association. If I really wanted to get back at someone for violating my confidentiality, my first complaint would be to their licensing board, even before I submitted a complaint to their employer or the federal government. Losing your license may kill your career, and being investigated by your licensing board will certainly get your attention.

When you are justifying the costs related to Security and Compliance, be sure to quantify the effect on your income, lifestyle, and retirement, if you were to lose your license.

CONTRACTS

Many of our clients have signed contracts with other organizations, that include cyber security requirements as a contractual obligation to do business together. These contracts are often reviewed by attorneys, signed by executives, and then filed away. The requirements are not always communicated to the people on the front lines.

In 2012, Omnicell, a drug cart manufacturer, breached the records of 68,000 patients when an employee’s unencrypted laptop was stolen. The health systems – clients of Omnicell –  announced that Omnicell’s contract with them included a requirement that patient data would only be stored on encrypted devices. The loss of the laptop became a breach of contract discussion, not just a simple data breach.

My guess is that the contract was signed, and then just filed away. I don’t think Omnicell’s purchasing department was told it was supposed to order encrypted laptops for its field technicians. I don’t think its IT department knew it had a contractual obligation to install encryption on all laptops, and I doubt the field tech knew he was violating a contract when he transferred patient data to his unencrypted computer. Worse, no one who was aware of the contract requirements was auditing the company’s compliance.

During a recent client visit, I asked if our client had signed any contracts with their clients. She went through a list that included one of the top health systems in the country. I’m not a lawyer, but I asked to see the contract, because I knew the health system had included cyber security requirements as a contractual obligation with our other clients.

After a few minutes, she returned with the file folder containing the contract. I found the cyber security section, and read it to her. I asked if her company was meeting the requirements in the contract. She said no. I asked her what the future of her business would look like if they lost the business of one of the country’s leading health systems, because they breached their contract. She replied that her business probably would not survive.

We focused our project around meeting the specific requirements of their contract, not the vague and flexible requirements in HIPAA.

INSURANCE

Cyber Liability (also known as Data Breach) Insurance is a popular line of revenue for insurance companies. Unlike malpractice insurance, which assumes you will make a mistake, cyber insurance may only protect you if you are doing all the things you included on your insurance application. It may pay a claim only if you are doing everything correctly, and still suffer a breach. What you answer on the application may come back to haunt you.

In 2013, Cottage Health’s IT vendor accidently published a file server to the Internet, exposing patient information. Patients Googling themselves got back their medical records. The patients filed a class action suit, so Cottage Health brought in Columbia Casualty, their cyber liability insurance provider, to provide legal representation, and settle the claim.

The lawsuit was settled for $4.1 million, which was paid by Columbia Casualty. Columbia told Cottage Health that, even though it was making the payment, it still reserved its rights and would continue investigating the case.

Columbia Casualty then sued its own client, Cottage Health, to get the $ 4.1 million back. It said it determined that Cottage Health had made misstatements when it answered questions on the original policy application, including that it regularly maintained security patches on its devices. Columbia also said it should be excluded from losses because Cottage Health failed to continuously maintain the level of security stated on its application.

The lawsuit said that it did not matter if Cottage Health was mistaken, or had intentionally lied on the application.

As part of our assessments, we review insurance applications. When we work with our clients, we help you implement consistent programs to maintain the level of security you claim on your application.

LAWSUITS

While you don’t comply with a lawsuit, watching court cases can help you understand your risks and how to protect your organization.

Many people think that a HIPAA Notice of Privacy Practices is just a basic brochure you have to include with new patient paperwork. A patient is suing her doctor for negligence after her information was shared without her authorization. She claimed that the practice did not follow its Notice of Privacy Practices, and the Connecticut Supreme Court upheld that HIPAA can be used as a Standard of Care in a negligence suit.

Walgreen’s lost $1.44 million in a lawsuit after a pharmacist breached a customer’s confidentiality. Walgreens proved its pharmacist had received HIPAA training and had signed a confidentiality agreement. The company said it had done everything possible to prevent the breach. The jury disagreed.

By looking at law suits you can see that attorneys are using compliance requirements as the basis for claims. That can be scarier compared to the likelihood is that the federal government will make the effort to go after you.

LESSONS LEARNED

It’s really easy to focus just on HIPAA and think you are compliant. It’s also a mistake.

HIPAA is vague. It is flexible, giving you a lot of freedom to choose how to comply with the regulation. The ‘HIPAA-in-a-Box’ solutions can give you a false sense of Security and Compliance, because they are so narrowly focused.

The Federal Trade Commission can assess stronger penalties than the OCR, the federal agency that enforces HIPAA. The FTC has put businesses on 20-year monitored compliance programs. When we work with our clients, we help you create written evidence that your security policies and procedures are working.

State laws can change your patient reporting requirements. They also protect confidential information you have for your workforce members. Your Incident Management program can’t just focus on HIPAA.

Industry requirements can be very serious. Can you risk not accepting credit cards? Contact the merchant service that processes your cards to make sure you are complying with PCI-DSS.

Verify the reporting requirements of the entities that license your staff. You may have an obligation to report a breach to them, instead of waiting for someone to file a complaint.

Review the contracts you have in your files for cyber security requirements, and note any in new contracts you are about to sign. Make sure everyone in your organization who must comply with the contract requirements know about them.

You can’t buy insurance instead of doing the right things to protect data. However, if you do things right insurance may save you millions of dollars. You should review your policy application every quarter, and demand evidence from your IT department or vendor that you are in compliance with the policy requirements. Too much work? Would you rather have your insurance company fail to pay a multi-million-dollar claim?

Keep repeating to yourself, “Compliance isn’t just about HIPAA” and uncover the rest of your compliance requirements.

About Mike Semel

Mike Semel is a noted thought leader, speaker, blogger, and best-selling author of HOW TO AVOID HIPAA HEADACHES . He is the President and Chief Security Officer of Semel Consulting, focused on HIPAA and other compliance requirements; cyber security; and Business Continuity planning. Mike is a Certified Business Continuity Professional through the Disaster Recovery Institute, a Certified HIPAA Professional, Certified Security Compliance Specialist, and Certified Health IT Specialist. He has owned or managed technology companies for over 30 years; served as Chief Information Officer (CIO) for a hospital and a K-12 school district; and managed operations at an online backup company.

Top Five Challenges of Healthcare Cloud Deployments and How to Solve Them

Posted on October 2, 2017 I Written By

The following is a guest blog post by Chad Kissinger, Founder of OnRamp.

According to the HIMSS 2016 Survey, 84 percent of providers are currently using a cloud service, showing security and compliance issues are not preventing organizations from deploying cloud environments. Despite growing adoption rates, breaches and security incidents continue to rise. Cloud deployments and ongoing environment management errors are to blame. 

Cloud services offer clear benefits—performance, cost savings, and scalability to name a few—so it’s no wonder healthcare organizations, like yours, are eager to take advantage of all that the cloud has to offer. Unfortunately, vulnerabilities are often introduced to your network when you adopt new technology. Let’s discuss how to identify and overcome common challenges in secure, compliant cloud deployments so you can opportunistically adopt cloud-based solutions while remaining on the right side of the law.

1. Ambiguous Delegation of Responsibilities
When technology is new to an organization, the responsibility of finding and managing that solution is often unclear. You must determine who owns your data. Is it your IT Department? Or perhaps your Security Department? It’s difficult to coordinate different people across departments, and even more difficult to communicate effectively between your organization and your provider. The delegation of responsibilities between you and your business associate will vary based on your service model—i.e. software as a service, infrastructure as a service, etc.

To prevent these issues, audit operational and business processes to determine the people, roles, and responsibilities for your team internally. Repeat the process for those services you will outsource to your cloud provider. Your business associate agreement should note the details of each party’s responsibilities, avoiding ambiguity and gaps in security or compliance. Look for provider credentials verified by third-party entities that demonstrate security levels at the data center level, such as HITRUST CSF and SSAE 16 SOC 2 Type 2 and SOC3.

2.    Lack of Policies, Standards, and Security Practices
If your organization doesn’t have a solid foundation of policies, standards, and security practices, you will likely experience one or more of the security-related issues outlined below. It’s necessary to not only create policies, but also ensure your organization is able to enforce them consistently.

  • Shadow IT. According to a recent HyTrust Cloud Survey of 51 organizations, 40% of cloud services are commissioned without IT input.
  • Cloud Portability and Mobility. Mitigating risks among many endpoints, from wearables to smart beds, becomes more difficult as you add more end points.
  • Privileged User Access. Divide your user access by work role and limit access to mitigate malicious insider attacks.
  • Ongoing Staff Education and Training. Your team needs to be properly trained in best practices and understand the role that they play in cybersecurity.

Proper security and compliance also involves the processes that safeguard your data and the documentation that proves your efforts. Such processes include auditing operational and business processes, managing people, roles and identities, ensuring proper protection of data and information, assessing the security provisions for cloud applications, and data decommissioning.

Communicate your security and compliance policies to your cloud provider to ensure their end of the operations falls in line with your overall plan.

3. Protecting Data and Meeting HIPAA Controls
The HIPAA Privacy Rule, the HIPAA Security Rule, and HITECH all aim to secure your electronic protected health information (ePHI) and establish the national standards. Your concern is maintaining the confidentiality, availability, and integrity of sensitive data. In practice, this includes:

  • Technology
  • Safeguards (Physical & Administrative)
  • Process
  • People
  • Business Associates & Support
  • Auditable Compliance

Network solution experts recognize HIPAA compliant data must be secure, but also needs to be readily available to users and retain integrity across platforms. Using experienced cloud solution providers will bridge the gap between HIPAA requirements, patient administration, and the benefit of technology to treat healthcare clients and facilitate care.

Seek the right technology and implement controls that are both “required and addressed” within HIPAA’s regulations. When it comes to security, you can never be too prepared. Here are some of the measures you’ll want to implement:

  • Data encryption in transit and at rest
  • Firewalls
  • Multi-factor Authentication
  • Cloud Encryption Key Management
  • Audit logs showing access to ePHI
  • Vulnerability scanning, intrusion detection/prevention
  • Hardware and OS patching
  • Security Audits
  • Contingency Planning—regular data backup and disaster recovery plan

The number one mistake organizations make in protected data in a cloud deployment is insufficient encryption, followed by key management. Encryption must be FIPS 140-2 compliant.

4.    Ensuring Data Availability, Reliability, and Integrity
The key to service reliability and uptime is in your data backups and disaster recovery (DR) efforts. Data backup is not the same as disaster recovery—this is a common misconception. Data backup is part of business continuity planning, but requires much more. There’s a gap between how organizations perceive their track records and the reality of their DR capabilities. The “CloudEndure Survey of 2016” notes that 90% of respondents claim they meet their availability, but only 38% meet their goals consistently, and 22% of the organizations surveyed don’t measure service availability at all. Keep in mind that downtime can result from your cloud provider—and this is out of your control. For instance, the AWS outage earlier this year caused a ruckus after many cloud-based programs stopped functioning.

5.    Ability to Convey Auditable Compliance (Transparency)
Investors, customers, and regulators cannot easily discern that your cloud environment is compliant because it’s not as visible as other solutions, like on-premise hosting. You will have to work closely with your cloud provider to identify how to document your technology, policies, and procedures in order to document your efforts and prove auditable compliance.

Putting It All Together
The cloud provides significant advantages, but transitioning into the cloud requires a thorough roadmap with checkpoints for security and compliance along the way. Remember that technology is just the first step in a secure cloud deployment—proper security and compliance also involves the processes that protect your sensitive data and the documentation that proves your compliance efforts. You’ll want to identify resources from IT, security and operations to participate in your cloud deployment process, and choose a cloud provider that’s certified and knowledgeable in the nuances of healthcare cloud deployments.

For more information download the white paper “HOW TO DEPLOY A SECURE, COMPLIANT CLOUD FOR HEALTHCARE.”

About OnRamp

OnRamp is a HITRUST-certified data center services company that specializes in high security and compliant hybrid hosting and is a proud sponsor of Healthcare Scene. Our solutions help organizations meet compliance standards including, HIPAA, PCI, SOX, FISMA and FERPA. As an SSAE 16 SOC 2 Type 2 and SOC 3, PCI-DSS certified, and HIPAA compliant company, OnRamp operates multiple enterprise-class data centers to deploy cloud computing, colocation, and managed services. Visit www.onr.com or call 888.667.2660 to learn more.

Business Associates are NOT Responsible for Clients’ HIPAA Compliance, BUT They Still Might Be At-Risk

Posted on August 25, 2017 I Written By

The following is a guest blog post by Mike Semel from Semel Consulting.

“Am I responsible for my client’s HIPAA compliance?”

“What if I tell my client to fix their compliance gaps, and they don’t? Am I liable?”

“I told a client to replace the free cable Internet router with a real firewall to protect his medical practice, but the doctor just won’t spend the money. Can I get in trouble?”

“We are a cloud service provider. Can we be blamed for what our clients do when using our platform?”

 “I went to a conference and a speaker said that Business Associates were going to be held responsible for their clients’ compliance. Is this true???”

I hear questions like these all the time from HIPAA Business Associates.

The answers are No, No, No, No, and No.

“A business associate is not liable, or required to monitor the activities of covered entities under HIPAA, but a BA has similar responsibilities as a covered entity with respect to any of its downstream subcontractors that are also BA’s,” said Deven McGraw, Deputy Director for Health Information Privacy, US Department of Health and Human Services Office for Civil Rights (OCR), Acting Chief Privacy Officer for the Office of the National Coordinator for Health Information Technology. on August 17, 2017.

So, while you aren’t responsible for your clients’ HIPAA compliance, what they do (or don’t do) still might cost you a lot, if you aren’t careful.

In my book, How to Avoid HIPAA Headaches, there are stories about HIPAA Covered Entities that suffered when their Business Associates failed to protect PHI. North Memorial Health Care paid $ 1.55 million in HIPAA penalties based on an investigation into the loss of an unencrypted laptop by one of its Business Associates, Accretive Health.

Cottage Health, a California healthcare provider, is being sued by its insurance company to get $ 4.1 million back from a settlement after Cottage Health’s IT vendor, a Business Associate,  accidently published patient records to the Internet.

Your marketing activities; what you and your salespeople say to prospects and clients; and your written Terms & Conditions; may all create liability and financial risks for you. These must be avoided.

Semel Consulting works with a lot of Business Associates.

Many are IT companies, because I spent over 30 years owning my own IT companies. I’ve been the Chief Information Officer for a hospital and a K-12 school district, and the Chief Operating Officer for a cloud backup company. I now lead a consulting company that helps clients address their risks related to regulatory compliance, cyber security, and disaster preparedness. I speak at conferences, do webinars, and work with IT companies that refer their clients to us.

I look at the world through risk glasses. What risks do our clients have? How can I eliminate them, minimize them, or share them? When we work with our healthcare and technology industry clients, we help you identify your risks, and quantify them, so you know what resources you should reasonably allocate to protect your finances and reputation.

Under HIPAA, compliance responsibility runs one way – downhill.

Imagine a patient on top of a hill. Their doctor is below the patient. You are the doctor’s IT support company, below the doctor, and any vendors or subcontractors you work with are below you.

The doctor commits to the patient that he or she will secure the patient’s Protected Health Information (PHI) in all forms – verbal, written, or electronic. This is explained in the Notice of Privacy Practices (NPP) that the doctor gives to patients.

Under HIPAA, the doctor is allowed to hire vendors to help them do things they don’t want to do for themselves. Vendors can provide a wide variety of services, like IT support; paper shredding; consulting; malpractice defense; accounting; etc. The patient is not required to approve Business Associates, and does not have to know that outsourcing is happening. This flexibility is also explained in the patient’s Notice of Privacy Practices.

As a vendor that comes in contact with PHI, or the systems that house it, you are a HIPAA Business Associate. This requires you to sign Business Associate Agreements and, since 2013, when the HIPAA Omnibus Final Rule went into effect, it also means that you must implement a complete HIPAA compliance program and be liable for any breaches you cause.

IT companies may decide to resell cloud services, online backup solutions, or store servers in a secure data center. Since the HIPAA Omnibus Final Rule went into effect, a Business Associate’s vendors (known as subcontractors) must also sign Business Associate Agreements with their customers, and implement complete HIPAA compliance programs.

Because compliance responsibility runs downhill, the doctor is responsible to the patient that his Business Associates will protect the patient’s confidential information. The Business Associates assures the doctor that they, and their subcontractors, will protect the patient’s confidential information. Subcontractors must commit to Business Associates that they will protect the information. A series of two-party agreements are required down the line from the doctor to the subcontractors.

It doesn’t work the other way. Subcontractors are not responsible for Business Associates, and Business Associates are not responsible for Covered Entities, like doctors.

HIPAA compliance responsibility, and legal and financial liability, are different.

A HIPAA Covered Entity is responsible for selecting compliant vendors. Business Associates are responsible for selecting compliant subcontractors. Subcontractors must work with compliant subcontractors.

Because Covered Entities are not liable for their Business Associates, and Business Associates are not liable for their Subcontractors, they are not required to monitor their activities. But, you still need to be sure your vendors aren’t creating risks. The Office for Civil Rights (OCR) says that:

… if a covered entity finds out about a material breach or violation of the contract by the business associate, it must take reasonable steps to cure the breach or end the violation, and, if unsuccessful, terminate the contract with the business associate. If termination is not feasible (e.g., where there are no other viable business alternatives for the covered entity), the covered entity must report the problem to the Department of Health and Human Services Office for Civil Rights. See 45 CFR 164.504(e)(1).

With respect to business associates, a covered entity is considered to be out of compliance with the Privacy Rule if it fails to take the steps described above. If a covered entity is out of compliance with the Privacy Rule because of its failure to take these steps, further disclosures of protected health information to the business associate are not permitted.

In its Cloud Service Provider (CSP) HIPAA Guidance released in 2016, the OCR said:

A covered entity (or business associate) that engages a CSP should understand the cloud computing environment or solution offered by a particular CSP so that the covered entity (or business associate) can appropriately conduct its own risk analysis and establish risk management policies, as well as enter into appropriate BAAs.  See 45 CFR §§ 164.308(a)(1)(ii)(A); 164.308(a)(1)(ii)(B); and 164.502. 

Both covered entities and business associates must conduct risk analyses to identify and assess potential threats and vulnerabilities to the confidentiality, integrity, and availability of all ePHI they create, receive, maintain, or transmit.  For example, while a covered entity or business associate may use cloud-based services of any configuration (public, hybrid, private, etc.),[3] provided it enters into a BAA with the CSP, the type of cloud configuration to be used may affect the risk analysis and risk management plans of all parties and the resultant provisions of the BAA.

How can a Business Associate be affected by a client’s compliance failure?  Here are some scenario’s.

(FYI, I am not a lawyer and this is not legal advice. These ideas came out of meetings I had with my attorney to review our contracts and our marketing. Talk to your lawyer to make sure you are protected!)

  1. IT companies should never tell your client, “We’ll be responsible for your IT so you can focus on your medical practice.”

Sound familiar? This is what many IT Managed Service Providers tell their prospects and clients.

Then the client has a data breach because they were too cheap to buy a firewall, they refused to let you implement secure passwords because it would inconvenience their staff, or they lost an unencrypted thumb drive even though you had set up a secure file sharing platform.

Someone files a HIPAA complaint, the OCR conducts an investigation, and your client pays a big fine. Then they sue you, saying you told them IT was your responsibility. Maybe they misunderstood what you included in your Managed Services. Maybe you did not clearly explain what responsibility you were accepting, and what IT responsibility was still theirs. Either way, you could spend a lot on legal fees, and even lose a lawsuit if a jury believes you made the client believe you were taking over their compliance responsibility.

  1. You must clearly identify what is, and what is not, included in your services.

Your client pays you a monthly fee for your services. Then they have a breach. They may expect that all the tasks you perform, and the many hours of extra labor you incur, are included in their monthly fee. They get mad when you say you will be charging them for additional services, even though they have just hired a lawyer at $ 500 per hour to advise them. Without written guidelines, you may not be able to get paid.

  1. You must be sure you get paid if your client drags you into something that is not your fault.

Imagine you were the IT company that set up an e-mail server for a recent presidential candidate. As unlikely as this may sound, this becomes a political issue. You just did what the client requested, but now you must hire attorneys to advise you. You must hire a public relations firm to deal with the media inquiries and protect your name in the marketplace. You must send your techs and engineers – your major source of a lot of income – to Washington for days to testify in front of Congress, after they spent more unbillable time preparing their testimony.

Who pays? How do you keep from losing your client? How do you protect your reputation?

HOW TO PROTECT YOUR FINANCES AND YOUR REPUTATION

  • Make sure you and your salespeople are careful to not overpromise your services. Make sure you and your sales team tell your prospects and clients that they are always ultimately responsible for their own security and compliance.
  • Make sure your contracts and Terms and Conditions properly protect you by identifying what services are/aren’t covered, and when you can bill for additional services. Don’t forget to include your management time when sending bills. Use a competent lawyer familiar with your needs to write your agreements and advise you on any agreements presented to you by others.
  • State in your Terms & Conditions that you will be responsible for your own company’s compliance (you are anyway) but that you are not responsible for your clients’ compliance.
  • Include terms that require your client to pay for ALL costs related to a compliance violation, government action, investigation, lawsuit, or other activity brought against them, that requires your involvement. Use a competent lawyer familiar with your needs to write your agreements and advise you on any agreements presented to you by others.
  • My attorney said we should include “change in government regulations” in our Force Majeure clause to allow us to modify our contract or our pricing before a contract expires. The 2013 HIPAA Omnibus Rule created a lot of expensive responsibilities for Business Associates. You don’t want to get stuck in an existing contract or price model if your costs suddenly increase because of a new law or rule.
  • Get good Professional Liability or Errors & Omissions insurance to protect you if you make a mistake, are sued, or dragged into a client’s investigation. Make sure you understand the terms of the policy and how it covers you. Make sure it includes legal representation. Ask for a custom policy if you need special coverage.
  • Make a negative a positive by promoting that you offer the specialized services clients will need in case they are ever audited, investigated, or sued.

If you do this right, you will protect your business and leverage compliance to increase your profits. When you focus on compliance, you can get clients willing to pay higher prices because you understand their compliance requirements. I know. I have generated millions of dollars in revenue using compliance as a differentiator.

About Mike Semel

Mike Semel is a noted thought leader, speaker, blogger, and best-selling author. He is the President and Chief Security Officer of Semel Consulting, focused on HIPAA (and other regulatory) compliance; cyber security; and Business Continuity planning. Mike is a Certified Business Continuity Professional through the Disaster Recovery Institute, a Certified HIPAA Professional, Certified Security Compliance Specialist, and Certified Health IT Specialist. He has owned or managed technology companies for over 30 years; served as Chief Information Officer (CIO) for a hospital and a K-12 school district; and managed operations at an online backup company.

A Programmatic Approach to Print Security

Posted on July 17, 2017 I Written By

The following is a guest blog post by Sean Hughes, EVP Managed Document Services at CynergisTek.

Print devices are a necessary tool to support our workflows but at the same time represent an increasing threat to the security of our environment.

Most organizations today have a variety of devices; printers, copiers, scanners, thermal printers and even fax machines that make up their “print fleet”. This complex fleet often represents a wide variety of manufacturers, makes and models of devices critical to supporting the business of healthcare.

Healthcare organizations continue to print a tremendous amount of paper as evidenced by an estimated 11% increase in print despite the introduction of the EHR and other new systems (ERPs, CRMs, etc.). More paper generally means more devices, and more devices means more risk, resulting in increased security and privacy concerns.

Look inside most healthcare organizations today and even those with a Managed Print Services program (MPS) probably have a very disjointed management responsibility of their inventory. Printers are most often the responsibility of IT, copiers run through supply chain with the manufacturer providing support, and fax machines may even be part of Telecommunications. Those organizations that have an MPS provider probably don’t have all devices managed under that program – what about devices in research or off-site locations, or what if you have an academic medical facility or are part of a university?

These devices do have a couple of things in common that are of concern – they are somehow connected to your network and they hold or process PHI.

This fact and the associated risk requires an organization to look at how these devices are being managed and whether the responsibility for security and privacy are being met. Are they part of your overall security program, does your third party manage that for you, do you even know where they all are and what risks are in your fleet today?  If multiple organizations manage, do they follow consistent security practices?

Not being able to answer these questions is a source of concern and probably means that the risk is real. So how do we resolve this?

We need to take a programmatic approach to print and print security to ensure we are addressing the whole. Let’s lay out some steps to accomplish this.

  • Know your environment – the first thing we must do is identify ALL print devices in our organization. This includes printers, scanners, copiers, thermals, and fax machines, whether they are facility owned, third-party managed, networked or local, or sitting in a storage room.
  • Assess your risk – perform a comprehensive security risk assessment of the entire fleet and develop a remediation plan. This is not a one-time event but rather needs to be part of your overall security plan.
  • Assign singular ownership of assets – either through an internal program or a third-party program, the healthcare organization should fold all print-related devices into a single program for accountability and management.
  • Workflow optimization – you probably have millions of dollars of software in your organization that is the source of the output of these devices. Even more was spent securing the environment these applications are housed in, and accessed from, to make sure the data is secure and privacy is maintained. The data in those systems is at its lowest price point, most optimal from a workflow efficiency standpoint, and most secure — yet every time we hit print we multiply the cost, decrease the operational efficiency and increase the risk to that data.
  • Decrease risk – while it is great that we identify all the devices, assess and document risk and develop a mitigation/remediation plan, the goal should be to put controls in place to stem the proliferation of devices and ultimately to begin the process of decreasing the unnecessary devices thereby eliminating the risk associated to those devices.

The concept of trying to reduce the number of printers from a cost perspective is not new to healthcare. However, many have achieved mixed results, even those that have used an MPS partner. The reason that happens is generally because they are focused on the wrong things.

The best way to accomplish a cost-effective print program is to understand what is driving the need or want for printers, and that is volume. You don’t need a print device if you don’t need to print. I know it sounds like I am talking about the nirvana that is the paperless environment but I am not. This is simply understanding what and where is unnecessary to print and eliminating it, thereby eliminating the underlying need for the associated device, and with it the inherent security risk as well as the privacy concern of the printed page. Refocusing on volume helps us to solve many problems simultaneously.

Putting a program in place that provides this visibility, and using that data to make the decisions on device reduction can significantly reduce your current risk. Couple this with security and privacy as part of your acquisition determination, and you can make intelligent decisions that ensure you only add those devices you need, and when you do add a device it meets your security and privacy requirements. More often than not the first line of defense in IT is better management of the environment.

Cybersecurity, MACRA, MIPS, HIPAA, and PCMH Training Workshops

Posted on May 3, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

I’ve been partnered with 4MedApproved for a long time offering healthcare IT training courses to my users. If you subscribe to a Healthcare Scene email list, then you’ve probably seen some emails offering a great discount on their training courses. 4Med really tries hard to listen to the community and create courses that are valuable to the healthcare IT professional.

They just sent me their list of upcoming courses and I was really impressed with the wide variety of courses that they’re offering between now and the end of July. Here’s a look a the courses they’re offering:

The good news is that by using any of the links above you’ll get a discount off of each of the courses for being a Healthcare Scene reader. Each of the above sessions is available as a live online training where you can ask the trainer questions. Also, if you miss one of the live sessions, then the recording will be made available to you after the event.

Also, for many of the courses, CEU are available to those who need them.

You can see on the list above that some of the most popular courses are around MACRA and healthcare security. Both are hugely important topics and there’s a lot of information to cover for both topics. If you’re dealing with either of them (which is most of you), these courses are a great resource for you to get up to speed on the latest.

5 Lessons In One Big HIPAA Penalty

Posted on February 2, 2017 I Written By

The following is a guest blog post by Mike Semel, President and Chief Compliance Officer at Semel Consulting.

The federal Office for Civil Rights just announced a $ 3.2 million penalty against Children’s Medical Center of Dallas.

5 Lessons Learned from this HIPAA Penalty

  1. Don’t ignore HIPAA
  2. Cooperate with the enforcers
  3. Fix the problems you identify
  4. Encrypt your data
  5. Not everyone in your workforce should be able to access Protected Health Information

If you think complying with HIPAA isn’t important, is expensive, and annoying, do you realize you could be making a $3.2 million decision? In this one penalty there are lots of hidden and not-so-hidden messages.

1. A $ 3.2 million penalty for losing two unencrypted devices, 3 years apart.

LESSON LEARNED: Don’t ignore HIPAA.

If Children’s Medical Center was paying attention to HIPAA as it should have, it wouldn’t be out $3.2 million that should be used to treat children’s medical problems. Remember that you protecting your patients’ medical information is their Civil Right and part of their medical care.

2. This is a Civil Money Penalty, not a Case Resolution.

What’s the difference? A Civil Money Penalty is a fine. It could mean that the entity did not comply with the investigation; (as in this case) did not respond to an invitation to a hearing; or did not follow corrective requirements from a case resolution. Most HIPAA penalties are Case Resolutions, where the entity cooperates with the enforcement agency, and which usually results in a lower dollar penalty than a Civil Money Penalty.

LESSON LEARNED: Cooperate with the enforcers. No one likes the idea of a federal data breach investigation, but you could save a lot of money by cooperating and asking for leniency. Then you need to follow the requirements outlined in your Corrective Action Plan.

3. They knew they had security risks in 2007 and never addressed them until 2013, after a SECOND breach.

Children’s Medical Center had identified its risks and knew it needed to encrypt its data as far back as 2007, but had a breach of unencrypted data in 2010 and another in 2013.

LESSON LEARNED: Don’t be a SLOW LEARNER. HIPAA requires that you conduct a Security Risk Analysis AND mitigate your risks. Self-managed risk analyses can miss critical items that will result in a breach. Paying for a risk analysis and filing away the report without fixing the problems can turn into a $ 3.2 million violation. How would you explain that to your management, board of directors, your patients, and the media, if you knew about a risk and never did anything to address it? How will your management and board feel about you when they watch $3.2 million be spent on a fine?

4. There is no better way to protect data than by encrypting it.

HIPAA gives you some leeway by not requiring you to encrypt all of your devices, as long as the alternative methods to secure the data are as reliable as encryption. There’s no such thing.

If an unencrypted device is lost or stolen, you just proved that your alternative security measures weren’t effective. It amazes me how much protected data we find floating around client networks. Our clients swear that their protected data is all in their patient care system; that users are given server shares and always use them; that scanned images are directly uploaded into applications; and that they have such good physical security controls that they do not need to encrypt desktop computers and servers.

LESSON LEARNED: You must locate ALL of your data that needs to be protected, and encrypt it using an acceptable method with a tracking system. We use professional tools to scan networks looking for protected data.

5. Not everyone in your workforce needs access to Protected Health Information.

We also look at paper records storage and their movement. This week we warned a client that we thought too many workforce members had access to the rooms that store patient records. The Children’s Medical Center penalty says they secured their laptops but “provided access to the area to workforce not authorized to access ePHI.”

LESSON LEARNED: Is your Protected Health Information (on paper and in electronic form) protected against unauthorized physical access by your workforce members not authorized to access PHI?

You can plan your new career after your current organization gets hit with a preventable $ 3.2 million penalty, just like Children’s Medical Center. Or, you can take HIPAA seriously, and properly manage your risks.

Your choice.

About Mike Semel
mike-semel-hipaa-consulting
Mike Semel is the President and Chief Compliance Officer for Semel Consulting. He has owned IT businesses for over 30 years, has served as the Chief Information Officer for a hospital and a K-12 school district, and as the Chief Operating Officer for a cloud backup company. Mike is recognized as a HIPAA thought leader throughout the healthcare and IT industries, and has spoken at conferences including NASA’s Occupational Health conference, the New York State Cybersecurity conference, and many IT conferences. He has written HIPAA certification classes and consults with healthcare organizations, cloud services, Managed Service Providers, and other business associates to help build strong cybersecurity and compliance programs. Mike can be reached at 888-997-3635 x 101 or mike@semelconsulting.com.

Don’t Worry About HIPAA – When Your License Is At-Risk!

Posted on October 24, 2016 I Written By

The following is a guest blog post by Mike Semel, President and Chief Compliance Officer at Semel Consulting.
medical-license-revoked
Not long ago I was at an ambulance service for a HIPAA project when one of their paramedics asked what the odds were that his employer would get a HIPAA fine if he talked about one of his patients. I replied that the odds of a HIPAA penalty were very slim compared to him losing his state-issued paramedic license, that would cost him his job and his career. He could also be sued. He had never thought of these risks.

Doctors, dentists, lawyers, accountants, psychologists, nurses, EMT’s, paramedics, social workers, mental health counselors, and pharmacists, are just some of the professions that have to abide by confidentiality requirements to keep their licenses.

License and ethical requirements have required patient and client confidentiality long before HIPAA and other confidentiality laws went into effect.  HIPAA became effective in 2003, 26 years after I became a New York State certified Emergency Medical Technician (EMT). Way back in 1977, the very first EMT class I took talked about my responsibility to keep patient information confidential, or I would risk losing my certification.

While licensed professionals may not talk about an individual patient or client, weak cybersecurity controls could cause a breach of ALL of their patient and client information – instantly.
health-data-encryption
Most certified and licensed professionals will agree that they are careful not to talk about patients and clients, but how well do they secure their data? Are their laptops encrypted? Are security patches and updates current? Do they have a business-class firewall protecting their network? Do they have IT security professionals managing their technology?
psychologist-loses-license-prostitute-takes-laptop
Lawyers have been sanctioned for breaching confidentiality. Therapists have lost their licenses. In one well-publicized case a psychologist lost his license when a prostitute stole his laptop. In rare cases a confidentiality breach will result in a jail sentence, along with the loss of a license.

Cyber Security Ethics Requirements
Lawyers are bound by ethical rules that apply to confidentiality and competence. The competence requirements typically restrict lawyers from taking cases in unfamiliar areas of the law. However, The American Bar Association has published model guidance that attorneys not competent in the area of cyber security must hire professionals to help them secure their data.

The State Bar of North Dakota adopted technology amendments to its ethics rules in early 2016. The State Bar of Wisconsin has published a guide entitled Cybersecurity and SCR Rules of Professional Conduct. In 2014, The New York State Bar Association adopted Social Media Ethics Guidelines. Lawyers violating these ethical requirements can be sanctioned or disbarred.

A State Bar of Arizona ethics opinion said “an attorney must either have the competence to evaluate the nature of the potential threat to the client’s electronic files and to evaluate and deploy appropriate computer hardware and software to accomplish that end, or if the attorney lacks or cannot reasonably obtain that competence, to retain an expert consultant who does have such competence.”

Some licensed professionals argue that their ethical and industry requirements mean they don’t have to comply with other requirements. Ethical obligations do not trump federal and state laws. Lawyers defending health care providers in malpractice cases are HIPAA Business Associates. Doctors that have to comply with HIPAA also must adhere to state data breach laws. Psychiatric counselors, substance abuse therapists, pharmacists, and HIV treatment providers have to comply with multiple federal and state confidentiality laws in addition to their license requirements.

There are some exemptions from confidentiality laws and license requirements when it comes to reporting child abuse, notifying law enforcement when a patient becomes a threat, and in some court proceedings.

While the odds of a federal penalty for a confidentiality breach are pretty slim, it is much more likely that someone will complain to your licensing board and kill your career. Don’t take the chance after all you have gone through to earn your license.

About Mike Semel
mike-semel-ambulance
Mike Semel is the President and Chief Compliance Officer for Semel Consulting. He has owned IT businesses for over 30 years, has served as the Chief Information Officer for a hospital and a K-12 school district, and as the Chief Operating Officer for a cloud backup company. Mike is recognized as a HIPAA thought leader throughout the healthcare and IT industries, and has spoken at conferences including NASA’s Occupational Health conference, the New York State Cybersecurity conference, and many IT conferences. He has written HIPAA certification classes and consults with healthcare organizations, cloud services, Managed Service Providers, and other business associates to help build strong cybersecurity and compliance programs. Mike can be reached at 888-997-3635 x 101 or mike@semelconsulting.com.

States Strengthen Data Breach Laws & Regulations

Posted on October 18, 2016 I Written By

The following is a guest blog post by Mike Semel, President and Chief Compliance Officer at Semel Consulting.

If your cyber security and compliance program is focused on just one regulation, like HIPAA or banking laws, many steps you are taking are probably wrong.

Since 2015 a number of states have amended their data breach laws which can affect ALL BUSINESSES, even those out of state, that store information about their residents. The changes address issues identified in breach investigations, and public displeasure with the increasing number of data breaches that can result in identity theft.

Forty-seven states, plus DC, Puerto Rico, Guam, and the US Virgin Islands, protect personally identifiable information, that includes a person’s name plus their Driver’s License number, Social Security Number, and the access information for bank and credit card accounts.

Many organizations mistakenly focus only on the data in their main business application, like an Electronic Health Record system or other database they use for patients or clients. They ignore the fact that e-mails, reports, letters, spreadsheets, scanned images, and other loose documents contain data that is also protected by laws and regulations. These documents can be anywhere – on servers, local PC’s, portable laptops, tablets, mobile phones, thumb drives, CDs and DVDs, or somewhere up in the Cloud.

Some businesses also mistakenly believe that moving data to the cloud means that they do not have to have a secure office network. This is a fallacy because your cloud can be accessed by hackers if they can compromise the local devices you use to get to the cloud. In most cases there is local data even though the main business applications are in the cloud. Local computers should have business-class operating systems, with encryption, endpoint protection software, current security patches and updates, and strong physical security. Local networks need business-class firewalls with active intrusion prevention.

States are strengthening their breach laws to make up for weaknesses in HIPAA and other federal regulations. Between a state and federal law, whichever requirement is better for the consumer is what those storing data on that state’s residents (including out of state companies) must follow.

Some states have added to the types of information protected by their data breach reporting laws. Many states give their residents the right to sue organizations for not providing adequate cyber security protection. Many states have instituted faster reporting requirements than federal laws, meaning that incident management plans that are based on federal requirements may mean you will miss a shorter state reporting deadline.

In 2014, California began requiring mandatory free identity theft prevention services even when harm cannot be proven. This year Connecticut adopted a similar standard. Tennessee eliminated the encryption safe harbor, meaning that the loss of encrypted data must be reported. Nebraska eliminated the encryption safe harbor if the encryption keys might have been compromised. Illinois is adding medical records to its list of protected information.

Massachusetts requires every business to implement a comprehensive data protection program including a written plan. Texas requires that all businesses that have medical information (not just health care providers and health plans) implement a staff training program.

REGULATIONS

Laws are not the only regulations that can affect businesses.

The New York State Department of Financial Services has proposed that “any Person operating under or required to operate under a license, registration, charter, certificate, permit, accreditation or similar authorization under the banking law, the insurance law or the financial services law” comply with new cyber security regulations. This includes banks, insurance companies, investment houses, charities, and even covers organizations like car dealers and mortgage companies who handle consumer financial information.

The new rule will require:

  • A risk analysis
  • An annual penetration test and quarterly vulnerability assessments
  • Implementation of a cyber event detection system
  • appointing a Chief Information Security Officer (and maintaining compliance responsibility if outsourcing the function)
  • System logging and event management
  • A comprehensive security program including policies, procedures, and evidence of compliance

Any organization connected to the Texas Department of Health & Human Services must agree to its Data Use Agreement, which requires that a suspected breach of some of its information be reported within ONE HOUR of discovery.

MEDICAL RECORDS

People often assume that their medical records are protected by HIPAA wherever they are, and are surprised to find out this is not the case. HIPAA only covers organizations that bill electronically for health care services, validate coverage, or act as health plans (which also includes companies that self-fund their health plans).

  • Doctors that only accept cash do not have to comply with HIPAA.
  • Companies like fitness centers and massage therapists collect your medical information but are not covered by HIPAA because they do not bill health plans.
  • Health information in employment records are exempt from HIPAA, like letters from doctors excusing an employee after an injury or illness.
  • Workers Compensation records are exempt from HIPAA.

Some states protect medical information with every entity that may store it. This means that every business must protect medical information it stores, and must report it if it is lost, stolen, or accessed by an unauthorized person.

  • Arkansas
  • California
  • Connecticut
  • Florida
  • Illinois (beginning January 1, 2017)
  • Massachusetts
  • Missouri
  • Montana
  • Nevada
  • New Hampshire
  • North Dakota
  • Oregon
  • Puerto Rico
  • Rhode Island
  • Texas
  • Virginia
  • Wyoming

Most organizations are not aware that they are governed by so many laws and regulations. They don’t realize that information about their employees and other workforce members are covered. Charities don’t realize the risks they have protecting donor information, or the impact on donations a breach can cause when it becomes public.

We have worked with many healthcare and financial organizations, as well as charities and general businesses, to build cyber security programs that comply with federal and state laws, industry regulations, contractual obligations, and insurance policy requirements. We have been certified in our compliance with the federal NIST Cyber Security Framework (CSF) and have helped others adopt this security framework, that is gaining rapid acceptance.

About Mike Semel
mike-semel-hipaa-consulting
Mike Semel is the President and Chief Compliance Officer for Semel Consulting. He has owned IT businesses for over 30 years, has served as the Chief Information Officer for a hospital and a K-12 school district, and as the Chief Operating Officer for a cloud backup company. Mike is recognized as a HIPAA thought leader throughout the healthcare and IT industries, and has spoken at conferences including NASA’s Occupational Health conference, the New York State Cybersecurity conference, and many IT conferences. He has written HIPAA certification classes and consults with healthcare organizations, cloud services, Managed Service Providers, and other business associates to help build strong cybersecurity and compliance programs. Mike can be reached at 888-997-3635 x 101 or mike@semelconsulting.com.