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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.

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.

Hybrid Entities Ripe For HIPAA Enforcement Actions

Posted on February 8, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she’s served as editor in chief of several healthcare B2B sites.

As some readers will know, HIPAA rules allow large organizations to separate out parts of the organization which engage in HIPAA-covered functions from those that do not. When they follow this model, known as a “hybrid entity” under HIPAA, organizations must take care to identify the “components” of its organization which engage in functions covered by HIPAA, notes attorney Matthew Fisher in a recent article.

If they don’t, they may get into big trouble, as signs suggest that the Office for Civil Rights will be taking a closer look at these arrangements going forward, according to attorneys.  In fact, the OCR recently hit the University of Massachusetts Amherst with a $650,000 fine after a store of unsecured electronic protected health information was breached. This action, the first addressing the hybrid entity standard under HIPAA, asserted that UMass had let this data get breached because it hadn’t treated one of its departments as a healthcare component.

UMass’s troubles began in June 2013, when a workstation at the UMass Center for Language, Speech and Hearing was hit with a malware attack. The malware breach led to the disclosure of patient names, addresses, Social Security numbers, dates of birth, health insurance information and diagnoses and procedure codes for about 1,670 individuals. The attack succeeded because UMass didn’t have a firewall in place.

After investigating the matter, OCR found that UMass had failed to name the Center as a healthcare component which needed to meet HIPAA standards, and as a result had never put policies and procedures in place there to enforce HIPAA compliance. What’s more, OCR concluded that – violating HIPAA on yet another level – UMass didn’t conduct an accurate and thorough risk analysis until September 2015, well after the original breach.

In the end, things didn’t go well for the university. Not only did OCR impose a fine, it also demanded that UMass take corrective action.

According to law firm Baker Donelson, this is a clear sign that the OCR is going to begin coming down on hybrid entities that don’t protect their PHI appropriately or erect walls between healthcare components and non-components. “Hybrid designation requires precise documentation and routine updating and review,” the firm writes. “It also requires implementation of appropriate administrative, technical and physical safeguards to prevent non-healthcare components from gaining PHI access.”

And the process of selecting out healthcare components for special treatment should never end completely. The firm advises its clients review the status of components whenever they are added – such as, for example, a walk-in or community clinic – or even when new enterprise-wide systems are implemented.

My instinct is that problems like the one taking place at UMass, in which hybrid institutions struggle to separate components logically and physically, are only likely to get worse as healthcare organizations consolidate into ACOs.

I assume that under these loosely consolidated business models, individual entities will still have to mind their own security. But at the same time, if they hope to share data and coordinate care effectively, extensive network interconnections will be necessary, and mapping who can and can’t look at PHI is already tricky. I don’t know what such partners will do to keep data not only within their network, but out of the hands of non-components, but I’m sure it’ll be no picnic.

Will Misunderstandings Around The HIPAA Conduit Exception Rule Result In Organizations Failing The Phase 2 Audits?

Posted on December 14, 2015 I Written By

The following is a guest blog post by Gene Fry from Scrypt, Inc.
Gene Fry - HIPAA Expert
In January 2013, the HHS defined the ‘conduit exception’ as part of the HIPAA Omnibus Final Rule, which was created to strengthen the privacy and security protections for health information.

The HIPAA conduit exception rule is applicable to providers of conduit services who do not have access to protected health information (PHI) on a routine basis. This means that they do not have to sign a Business Associate Agreement (BAA). However, some providers who do not fall under this definition are still claiming that they are HIPAA compliant. It is crucial that healthcare organizations understand exactly what this rule means, and how it may affect them if selected for an audit, or if a breach should occur.

What is a HIPAA Business Associate Agreement?
There are a number of providers who state they offer HIPAA compliant solutions for transmitting or storing PHI, and yet they are unwilling to sign a BAA.

As stated in the HIPAA Privacy and Security Rules, a business associate is defined as:

“[a] Health Information Organization, E-prescribing Gateway, or other person that provides data transmission services with respect to protected health information to a covered entity and that requires access on a routine basis to such protected health information.”

Therefore, any organization or business that handles personal health information is considered to be a business associate and must sign a BAA. As this acts as a contract between a HIPAA covered entity and a business associate, without one, the provider is not accountable for protecting the PHI it is handling or transmitting – meaning that they are not HIPAA compliant.

Phase 2 HIPAA audits are due to begin in early 2016, and the transmission and storage of PHI is likely to be an area that the Office of Civil Rights (OCR) focus on as a result of large numbers of noncompliance being reported in the phase 1 audits conducted in 2012. While the phase 1 audits applied only to covered entities, in this round, business associates will also be subject to audits by OCR. This means that business associates can be held accountable for data breaches, and penalized accordingly for noncompliance.

Every covered entity must have a BAA in place with the organization responsible for PHI managed on their behalf. Without it, like a weak link in the chain, the whole system becomes noncompliant.

When does the exception rule apply?
There are instances where the HIPAA conduit exception rule does apply. For entities that simply transport or transmit PHI (such as the United States Postal Service, couriers, and their electronic equivalents) who do not have routine access to PHI other than infrequently or randomly, and disclosure of the PHI to such entity is not intended, the HIPAA conduit exception rule is likely to apply.

The rule is rather confusing and open to interpretation when it comes to electronic protected health information (ePHI), as occasional, random access by a data transmission entity does not necessarily make the entity a HIPAA business associate. An example of an organization which would not require a BAA would be an ISP, as they review whether ePHI being transmitted over its network is arriving to its intended destination, but do not access or store the data.

Random or infrequent access defined by the HIPAA rules is explained in the preamble to the rules, which explicitly states that the “mere conduit” exception, is intended to include organizations that deal with “any temporary storage of transmitted data incident to such transmission.” It is the ‘temporary storage’ terminology used in the rule that healthcare organizations often misinterpret.

The preamble defines the distinction between transmission (including incidental storage associated with such transmission) and ongoing storage. The difference between those two situations “is the transient versus persistent nature of” the opportunity to access PHI. This means that a data storage company that has access to PHI still qualifies as a business associate, even if the entity does not view the information – or only does so on a random or infrequent basis.

Be wary of providers who refuse to sign a BAA
If a provider is unwilling to sign a BAA, the advice from David Holtzman of the U.S. Health and Human Services Department’s Office for Civil Rights, Privacy Division, is “If they refuse to sign, don’t use the service”.

However, providers are citing the HIPAA conduit exception rule as the reason that a BAA is not required. By stating that they are acting as a ‘simple conduit for information’, they are stipulating that they are excluded from the definition of a business associate. This effectively absolves the provider of signing a BAA, and gets them off the compliance hook, while putting their customers at risk of not being compliant.

An entity that manages the transmission and storage of PHI, such as a HIPAA compliant cloud hosting company, or a HIPAA compliant fax or messaging provider does have more than “random access” to PHI – meaning that they do meet the definition of a HIPAA business associate. Any organization that is transmitting and receiving information that includes PHI falls into the category of business associates – and should be willing to sign a BAA.

Some providers will not sign a BAA because they claim to only offer what they call a “conduit service” – technically making them able to state that they are HIPAA compliant, although this is untrue in many cases. In addition to offering services that relate to the transmission and storage of PHI, they may also include a guarantee that they will disable automatic forwarding of messages to email, disable SMS texting, and will delete all faxes, voicemails and recordings after a short period to get out of signing the BAA.

Providers who offer a range of telecommunications services – some of which are purely conduit – may also refuse to sign a BAA for customers only requiring data transmission services due to the fact that their fax and SMS services are not actually HIPAA compliant. Again, these providers claim that they are HIPAA compliant because they can provide purely conduit services as part of their offering.

How can I ensure compliance when selecting a provider?

  • Never select a provider who is unwilling to sign a BAA.
  • Be wary of providers who refer to the HIPAA conduit exception rule if they will have access to ePHI – even if it is random or infrequent
  • Ask the provider to prove its track record of safeguarding ePHI
  • Check that the provider is able to demonstrate that their staff are trained in HIPAA compliance

When selecting a provider, if they are truly HIPAA compliant, they will sign a business associate agreement because they are required to, and they should demonstrate a willingness to comply. A BAA acts as the a contract between a HIPAA covered entity and a business associate, and without one, the provider is not accountable for protecting the PHI it is handling or transmitting – meaning that they are not HIPAA compliant. Be wary of organizations that hide behind the conduit exception rule, or you may find your organization bears the brunt of OCR audits should a breach occur.

About Gene Fry
Gene joined the Scrypt, Inc. family in October of 2001. He has 25 years of IT experience working in industries such as healthcare and for companies based in the U.S. and in Latin America. Gene is a Certified HIPAA Professional (CHP) through the Management and Strategy Institute. In addition, he is certified as a HIPAA Privacy and Security Compliance Officer by the Identity Management Institute, as an Electronic Health Record Specialist Certification (CEHRS™) through the National Health Career Association and he holds a Gramm-Leach Bliley Act (GLBA) certification from BridgeFront and J.J Kellers.  In his spare time, Gene rides a Harley Davidson as part of the Austin, Texas Chapter.

Healthcare Providers and Patients Deserve Better Security

Posted on June 1, 2015 I Written By

The following is a guest blog post by Anna Drachenberg, Founder and CEO of HIPAA Risk Management.
Anna Drachenberg

Our firm has been helping dentists and other healthcare providers with their HIPAA security compliance for several years. Based on our customers’ experience, many dentists lack healthcare IT partners who are committed to data security and HIPAA compliance.  Unfortunately, this lack of commitment appears to be an epidemic across healthcare IT, and healthcare providers and patients need to demand a change.

In our recent alert, Dentrix Vulnerabilities and Mitigation for HIPAA Compliance, we described two major vulnerabilities we’ve had to assist our clients in mitigating in order to protect their patients’ data and comply with our clients’ HIPAA security policies. Our regulatory and data security experts were concerned, on behalf of our clients, with the way Henry Schein handled these two issues. More concerning, this seems to be a trend with many healthcare IT companies.

From the article, “In October 2012, it was reported to the Community Emergency Response Team (CERT) that all Dentrix G5 software was installed with hard-coded credentials to access the back-end database.” Pretty serious, right? The National Vulnerability Database gave this a severity score of 5.0 and an exploitability score of 10.0.  In the CERT notification you can see that the vulnerability was credited to Justin Shafer, not the vendor, Henry Schein, and there are several months between the time that the exploit was reported (11/22/2012) until Henry Schein released a fix for the issue (2/13/2013). Read the linked article for more details on the fix Henry Schein provided.

In a time when most industries are embracing security and offering “bug bounties,” many in the healthcare IT industry are trying to ignore the problem and hope that their customers are ignoring it, too. Take the recent panic over hackers controlling airplanes. What did United Airlines do? Offer a bug bounty that pays out in airlines miles that can be redeemed for free tickets. Most software and IT companies offer similar bug bounty programs and actively cooperate with independent security professionals. These companies know that every bug that is found before it is exploited can save millions of dollars and improve their product.

I’d like to challenge all of the blog readers today to find a healthcare IT vendor who has the same approach to security. For that matter, do a search on CERT vulnerability database or the National Vulnerability Database for any healthcare software or product you know or general terms like medical, hospital, healthcare. Surprised at the lack of issues reported and fixed? Are we really supposed to believe that the healthcare IT developers are superior to other industries?

Note: The only results in a search I did on 5/30/2015 of the National Vulnerability Database for “Epic” returns vulnerabilities in the Epic Games Unreal Tournament Engine. It is good to know that my video game company cares about my data security.

Everyone who purchases, administers, and uses healthcare IT systems and software deserves vendors who are committed to security. Consider for a moment – the customers of these products are the responsible parties for ensuring the security of the data they put in to these systems. Although the change to business associates under the HIPAA Omnibus Rule puts more liability on some of these vendors, the covered entity is still ultimately responsible and takes the hit to its reputation. Patients, the ones who experience harm when these systems are breached, have to rely on their doctors and other healthcare providers to ensure that the healthcare IT software and products are secure.  I don’t know about you, but I really hope that my physician spent more time in medical school learning about medicine than he did about encryption.

It’s time for all of us in the healthcare industry to demand that our vendors have the same level of commitment to security as the healthcare providers who are their customers. It’s time for all of us as patients to demand that these vendors improve the security of the products used by our healthcare providers.

One last note. In our alert, we link to Dentrix’s notice on the type of “encryption” they offer on one of their products. From Dentrix’s article:

“Henry Schein introduced cryptographic technology in Dentrix version G5 to supplement a practice’s employee policies, physical safeguards and data security. Available only in Dentrix G5, we previously referred to this feature as encryption. Based on further review, we believe that referring to it as a data masking technique using cryptographic technology would be more appropriate. Regardless of what you call it…”

To your clients, it matters what the federal government “calls” it, and they don’t call it encryption.

About Anna Drachenberg
Anna Drachenberg has more than 20 years in the software development and healthcare regulatory fields, having held management positions at Pacificare Secure Horizons, Apex Learning and the Food and Drug Administration. Anna co-founded HRM Services, Inc., (hipaarisk.com) a data security and compliance company for healthcare. HRM offers online risk management software for HIPAA compliance and provides consulting services for covered entities and business associates. HRM has clients nationwide and also partners with IT providers, medical associations and insurance companies.

There’s More to HIPAA Compliance Than Encryption

Posted on March 24, 2015 I Written By

The following is a guest blog post by Asaf Cidon, CEO and Co-Founder of Sookasa.
Asaf Cidon
The news that home care provider Amedisys had a HIPAA breach involving more than 100 lost laptops—even though they contained encrypted PHI—might have served as a wake-up call to many healthcare providers.  Most know by now that they need to encrypt their files to comply with HIPAA and prevent a breach. While it’s heartening to see increased focus on encryption, it’s not enough to simply encrypt data. To ensure compliance and real security, it’s critical to also manage and monitor access to protected health information.

Here’s what you should look for from any cloud-based solution to help you remain compliant.

  1. Centralized, administrative dashboard: The underlying goal of HIPAA compliance is to ensure that ­­organizations have meaningful control over their sensitive information. In that sense, a centralized dashboard is essential to provide a way for the practice to get a lens into the activities of the entire organization. HIPAA also stipulates that providers be able to get Emergency Access to necessary electronic protected health information in urgent situations, and a centralized, administrative dashboard that’s available on the web can provide just that.
  1. Audit trails: A healthcare organization should be able to track every encrypted file across the entire organization. That means logging every modification, copy, access, or share operation made to encrypted files—and associating each with a particular user.
  1. Integrity control: HIPAA rules mandate that providers be able to ensure that ePHI security hasn’t been compromised. Often, that’s an element of the audit trails. But it also means that providers should be able to preserve a complete history of confidential files to help track and recover any changes made to those files over time. This is where encryption can play a helpful role too: Encryption can render it impossible to modify files without access to the private encryption keys.
  1. Device loss / theft protection: The Amedisys situation illustrates the real risk posed by lost and stolen devices. Amedisys took the important first step of encrypting sensitive files. But it isn’t the only one to take. When a device is lost or stolen, it might seem like there’s little to be done. But steps can and should be taken to decrease the impact a breach in progress. Certain cloud security solutions provide a device block feature, which administrators can use to remotely wipe the keys associated with certain devices and users so that the sensitive information can no longer be accessed. Automatic logoff also helps, because terminating a session after a period of inactivity can help prevent unauthorized access.
  1. Employee termination help: Procedures should be implemented to prevent terminated employees from accessing ePHI. But the ability to physically block a user from accessing information takes it a step further. Technical tools such as a button that revokes or changes access permission in real-time can make a big impact.

Of course encryption is still fundamental to HIPAA compliance. In fact, it should be at the center of any sound security policy—but it’s not the only step to be taken. The right solution for your practice will integrate each of these security measures to help ensure HIPAA compliance—and overall cyber security.

About Asaf Cidon
Asaf Cidon is CEO and co-founder of cloud security company Sookasa, which encrypts, audits and controls access to files on Dropbox and connected devices, and complies with HIPAA and other regulations. Cidon holds a Ph.D. from Stanford University, where he specialized in mobile and cloud computing.

HIPAA Compliance and Windows Server 2003

Posted on February 12, 2015 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.

Last year, Microsoft stopped updating Windows XP and so we wrote about how Windows XP would no longer be HIPAA compliant. If you’re still using Windows XP to access PHI, you’re a braver person that I. That’s just asking for a HIPAA violation.

It turns out that Windows Server 2003 is 5 months away from Microsoft stopping to update it as well. This could be an issue for many practices who have a local EHR install on Windows Server 2003. I’d be surprised if an EHR vendor or practice management vendor was running a SaaS EHR on Windows Server 2003 still, but I guess it’s possible.

However, Microsoft just recently announced another critical vulnerability in Windows Server 2003 that uses active directory. Here are the details:

Microsoft just patched a 15-year-old bug that in some cases allows attackers to take complete control of PCs running all supported versions of Windows. The critical vulnerability will remain unpatched in Windows Server 2003, leaving that version wide open for the remaining five months Microsoft pledged to continue supporting it.

There are a lot more technical details at the link above. However, I find it really interesting that Microsoft has chosen not to fix this issue in Windows Server 2003. The article above says “This Windows vulnerability isn’t as simple as most to fix because it affects the design of core Windows functions rather than implementations of that design.” I assume this is why they’re not planning to do an update.

This lack of an update to a critical vulnerability has me asking if that means that Windows Server 2003 is not HIPAA compliant anymore. I think the answer is yes. Unsupported systems or systems with known vulnerabilities are an issue under HIPAA as I understand it. Hard to say how many healthcare organizations are still using Windows Server 2003, but this vulnerability should give them a good reason to upgrade ASAP.

Beware: Don’t Buy In to Myths about Data Security and HIPAA Compliance

Posted on January 22, 2015 I Written By

The following is a guest blog post by Mark Fulford, Partner in LBMC’s Security & Risk Services practice group.
Mark Fulford
Myths abound when it comes to data security and compliance. This is not surprising—HIPAA covers a lot of ground and many organizations are left to decide on their own how to best implement a compliant data security solution. A critical first step in putting a compliant data security solution in place is separating fact from fiction.  Here are four common misassumptions you’ll want to be aware of:

Myth #1: If we’ve never had a data security incident before, we must be doing OK on compliance with the HIPAA Security Rule.

It’s easy to fall into this trap. Not having had an incident is a good start, but HIPAA requires you to take a more proactive stance. Too often, no one is dedicated to monitoring electronic protected health information (ePHI) as prescribed by HIPAA. Data must be monitored—that is, someone must be actively reviewing data records and security logs to be on the lookout for suspicious activity.

Your current IT framework most likely includes a firewall and antivirus/antimalware software, and all systems have event logs. These tools collect data that too often go unchecked. Simply assigning someone to review the data you already have will greatly improve your compliance with HIPAA monitoring requirements, and more importantly, you may discover events and incidents that require your attention.

Going beyond your technology infrastructure, your facility security, hardcopy processing, workstation locations, portable media, mobile device usage and business associate agreements all need to be assessed to make sure they are compliant with HIPAA privacy and security regulations. And don’t forget about your employees. HIPAA dictates that your staff is trained (with regularly scheduled reminders) on how to handle PHI appropriately.

Myth #2: Implementing a HIPAA security compliance solution will involve a big technology spend.

This is not necessarily the case.  An organization’s investment in data security solutions can vary, widely depending on its size, budget and the nature of its transactions. The Office for Civil Rights (OCR) takes these variables into account—certainly, a private practice will have fewer resources to divert to security compliance than a major corporation. As long as you’ve justified each decision you’ve made about your own approach to compliance with each of the standards, the OCR will take your position into account if you are audited.

Most likely, you already have a number of appropriate technical security tools in place necessary to meet compliance. The added expense will more likely be associated with administering your data security compliance strategy.

Myth #3: We’ve read the HIPAA guidelines and we’ve put a compliance strategy in place. We must be OK on compliance.

Perhaps your organization is following the letter of the law. Policies and procedures are in place, and your staff is well-trained on how to handle patient data appropriately. By all appearances, you are making a good faith effort to be compliant.

But a large part of HIPAA compliance addresses how the confidentiality, integrity, and availability of ePHI is monitored in the IT department. If no one on the team has been assigned to monitor transactions and flag anomalies, all of your hard work at the front of the office could be for naught.

While a ‘check the box’ approach to HIPAA compliance might help if you get audited, unless it includes the ongoing monitoring of your system, your patient data may actually be exposed.

Myth #4: The OCR won’t waste their time auditing the ‘little guys.’ After all, doesn’t the agency have bigger fish to fry?

This is simply not true. Healthcare organizations of all sizes are eligible for an audit. Consider this cautionary tale: as a result of a reported incident, a dermatologist in Massachusetts was slapped with a $150,000 fine when an employee’s thumb drive was stolen from a car.

Fines for non-compliance can be steep, regardless of an organization’s size. If you haven’t done so already, now might be a good time to conduct a risk assessment and make appropriate adjustments. The OCR won’t grant you concessions just because you’re small, but they will take into consideration a good faith effort to comply.

Data Security and HIPAA Compliance: Make No Assumptions

As a provider, you are probably aware that the audits are starting soon, but perhaps you aren’t quite sure what that means for you. Arm yourself with facts. Consult with outside sources if necessary, but be aware that the OCR is setting the bar higher for healthcare organizations of all sizes. You might want to consider doing this, too. Your business—and your patients—are counting on it.

About Mark Fulford
Mark Fulford is a Partner in LBMC’s Security & Risk Services practice group.  He has over 20 years of experience in information systems management, IT auditing, and security.  Marks focuses on risk assessments and information systems auditing engagements including SOC reporting in the healthcare sector.  He is a Certified Information Systems Auditor (CISA) and Certified Information Systems Security Professional (CISSP).   LBMC is a top 50 Accounting & Consulting firm based in Brentwood, Tennessee.

Top 4 HIT Challenges and Opportunities for Healthcare Organizations in 2015 – Breakaway Thinking

Posted on January 15, 2015 I Written By

The following is a guest blog post by Mitchell Woll, Instructional Designer at The Breakaway Group (A Xerox Company). Check out all of the blog posts in the Breakaway Thinking series.
Mitchell Woll - The Breakaway Group
Healthcare organizations face numerous challenges in 2015: ICD-10 implementation, HIPAA compliance, new Meaningful Use objectives, and the Office of the National Coordinator’s (ONC) interoperability road map.  To adapt successfully, organizations must take advantage of numerous opportunities to prepare.

Healthcare leaders must thoroughly assess, prioritize, prepare, and execute in each area:

  1. Meaningful Use Stage 2 objectives require increased patient engagement and reporting for a full year before earning incentives.
  2. The ONC’s interoperability road map demands a new framework to achieve successful information flow between healthcare systems over the next ten years.
  3. There are 10 months left in which to prepare for the October 1 ICD-10 deadline.
  4. HIPAA compliance will be audited.

1. Meaningful Use
For those who have already implemented an EHR, Meaningful Use Stage 2 focuses new efforts on patient access to personal health data and emphasizes the exchange of health information between patient and providers. Stage 2 also imposes financial penalties for failure to meet requirements.

CMS’s latest deadline for Stage 2 extends through 2016, so healthcare organizations have additional time to fulfill Stage 2 requirements. Stage 3 requirements begin in 2017, so healthcare organizations should take the extra time to build interoperability and foster an internal culture of collaboration between providers and patients. For Stage 3, Medicare incentives will not apply in 2017 and EHR penalties will rise to 3 percent.

CMS has also proposed a 2015 EHR certification, which requests interoperability enhancement to support transitions of care.  Complying with this certification is voluntary, but provides the opportunity to become certified for Medicare and Medicaid EHR incentive programs at the same time.

Meaningful Use Stage 2 and the ONC roadmap require that 2015 efforts concentrate on interoperability. Healthcare organizations should prepare for health information exchange by focusing efforts on building patient portals and integrating communications by automating phone, text, and e-mail messages. After setting up successful exchange methods, healthcare organizations should train staff how to use patient portals. The delay in Stage 2 means providers have more time to become comfortable using the technology to correspond with patients. Hospitals should also educate patients about these resources, describing the benefits of collaboration between providers and patients. Positive collaboration and successful data exchange helps achieve desired health outcomes faster.

2. Interoperability
The three-year goal of the ONC’s 10-year roadmap is for providers and patients to be able to send, receive, find, and use basic health information. The six and ten-year goals then build on the initial objectives, improving interoperability into the future.

Congress has also shown initiative on promoting interoperability asking the ONC to investigate information blocking by EHRs. Most of the ONC’s roadmap for the next three years is similar to Meaningful Use Stage 2 goals.

Sixty-four percent of Americans do not use patient portals, so for 2015 healthcare organizations should focus on creating them, refining their workflows, and encouraging patients to use them. Additionally, 35 percent of patients said they are unaware of patient portals, while 31 percent said their physician has never mentioned them. Fifty-six percent of patients ages 55-64, and 46 percent of patients 65 and older, said they would access medical information more if it were available online. Hospitals need their own staff to use and promote patient portals in order to conquer the challenges of interoperability and Stage 2.

3. HIPAA Compliance
In 2015, the Office of the Inspector General (OIG) will audit EHR use, looking closely at HIPAA security, incentive payments, possible fraud, and contingency plan requirements. Also during the HIPAA compliance audit, the Office of Civil Rights (OCR) will confirm whether hospitals’ policies and procedures meet updated security criteria.  Healthcare organizations should take this opportunity to verify compliance with 2013 HIPAA standards to prepare for upcoming audits. Many helpful resources exist, including HIPAA compliance toolkits, available from several publishers. These kits include advice on privacy and security models. Healthcare organizations and leaders can also take advantage of online education, or hire consultants to help review and implement the necessary measures. It’s important that action be taken now to educate staff about personal health information security and how to remain HIPAA compliant.

4. ICD-10 Deadline
The new ICD-10 deadline comes as no surprise now that it was delayed several times. In July 2014, the US Department of Health and Human Services (HHS) implemented the most recent delay and set a new date of Oct. 1, 2015, giving hospitals a 10-month window to prepare for the eventual ICD-10 rollout. Because healthcare organizations are more adaptable than ever, they can use their practiced flexibility and experience to meet these demands successfully.

As Health Information and Management Systems Society (HIMSS) suggests, communication, education and testing must be part of an ICD-10 implementation plan. Informing internal staff and external partners of the transition is a crucial first step. ICD-10 should be tested internally and externally to verify the system works with the new codes before the transition. Healthcare organizations should outline and develop an ICD-10 training program by selecting a training team and assessing the populations who need ICD-10 education. They should perform a gap analysis to understand the training needed and utilize role-based training to educate the proper populations. Finally, organizations should establish the training delivery method, whether online, in the classroom, one-on-one, or some combination of these to teach different topics or levels of proficiency. In my experience at The Breakaway Group, I’ve seen that the most effective and efficient education is role-based, readily-accessible, and offers learners hands-on experience performing tasks essential to their role. This type of targeted education ensures learners are proficient before the implementation. As with any go-live event, healthcare organizations must prepare and deliver the new environment, providing support throughout the event and beyond.

Facing 2015
These challenges require the same preparation, willingness, and audacity needed for prior HIT successes, including EHR implementation and meeting Meaningful Use Stage 1 requirements. ICD-10, HIPAA compliance, Stage 2, and interoperability all have the element of education in common. Healthcare organizations and leaders should apply the same tenacity and discipline to inform, educate, and prepare clinicians for upcoming obligations.

Targeted role-based education will best ensure proficiency and avoid comprehensive, costly, and time-consuming system training. Through role-based education, healthcare organizations gain more knowledgeable personnel who are up to speed on new applications. These organizations probably already have at least a foundation for 2015 expectations, and they should continue to recall the strategies used for prior go-live events. What was successful? It’s important to plan to replicate successful strategies, alleviating processes that caused problems.  This is great opportunity to capitalize efforts for organizational improvements. Healthcare leaders must let the necessity of 2015 government requirements inspire invention and innovation, ultimately strengthening their organizations.

Xerox is a sponsor of the Breakaway Thinking series of blog posts.