Category Archives: Business Associates Agreements

$ 3.5 Million Dollar Fine for Fresenius Medical Care North America (FMCNA) to settle potential violations of the HIPAA Privacy and Security Rules for FIVE different breaches.

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RISKAlert Report Updated: Feb 2, 2018

FMCNA, a German company with US Operations based in  Waltham, Massachusetts, has agreed to pay a hefty $ 3.5 million dollar fine that covers 5 separate HIPAA Violations.

FMCNA is a provider of products and services for people with chronic kidney failure with over 60,000 employees that serves over 170,000 patients. Their facilities include dialysis facilities, outpatient cardiac and vascular labs, and urgent care centers, as well as hospitals and post-acute care providers.

US Dept. of Health and Human Services said the company failed to heed HIPAA’s risk analysis and risk management rules. FMCNA is also required to adopt a Comprehensive Corrective Action Plan. DHHS’ Office of Civil Rights,(OCR) investigation into the data incidents found that FMCNA covered entities failed to conduct an accurate and thorough risk analysis of potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its ePHI.

The breaches spanned three states including Florida, Alabama, and Georgia. Each provider had specific
deficiencies and the Agreement calls out each deficiency by provider. You can read the entire Resolution Agreement at https://www.hhs.gov/sites/default/files/fresenius-racap.pdf.

Fresenius Medical Care’s corporate headquarters is in Bad Homburg, Germany. The North American headquarters is in Waltham, Massachusetts and the Asian-Pacific headquarters is located in Hong Kong.

LESSONS LEARNED:

1. All providers need to have a current Risk Analysis that identifies potential threats,
     analyzed solutions, and provides a concrete plan to fix any deficiencies. The Risk Analysis
     must adjust to new threats, such as Ransomware attacks.

2. Covered entities like FMCNA are responsible for all the providers in their network.

THANKS FOR READING THE RISKAlert Report©

For more information and more great content:
www.riskandsecurityllc.com or www.caroline-hamilton.com

For a no-cost subscription, write to caroline@riskandsecurityllc.com

Last-Minute HIPAA Compliance Tips

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With only 2 weeks (15 days) left to meet the HIPAA Omnibus Rule, let’s say you
have done everything you could possibly do, to be in full compliance with every
part of HIPAA:

1. Finish a current HIPAA Risk Analysis – CHECK

2. Rewrite Business Associate agreements – CHECK

3. Rewrite Policies & Procedures – CHECK

4. Get PHI off the office copiers – CHECK

5. Gather Documentation in one place – CHECK

6. Start HIPAA Security Awareness Program – CHECK

7. Update HR Sanctions Policies – CHECK

8. Finalize Contingency Plans – CHECK

9. Add more encryption – CHECK

10. Implement Plan for Smartphones & Mobile Devices – CHECK

11. Have staff sign new Affirmation Agreements – CHECK

And in spite of your careful preparation, you walk into work on Monday, and the OCR
regulators are sitting in the Lobby, and they’ve been there since 7:00 AM!

No matter what else you have done, or started, and have not done, your insurance policy is to be
able to pull out your most current (in months, not years) HIPAA Risk Analysis and then pull out all
your supporting documentation including:

1. All information, including network diagrams, on where the PHI is on your network, and the
automated network controls you have implemented.

2. A record of every application, every database, etc. that hold PHI, are used to create,
manage, or share PHI, in both electronic and paper form.

2. Rosters going back 3 years of everyone in the organization who’s taken HIPAA training.

3. A copy of the Policies and Procedures, and Security Plans, printed out and labeled in 3-ring
Binders.

4. List of all HIPAA controls that are currently in place and verification documents.

5. Copies of all Business partners agreements and contracts

6. A notarized statement signed by the Board Director, CEO or Administrator formally
stating the organization’s Commitment to HIPAA Security & Privacy & Omnibus Rules.

7. Copies of recent employee surveys validating their stated compliance with all HIPAA
Security, Privacy, and Omnibus Rules.

All of these elements should be printed in their most current versions and put in D-Ring
binders, which you will pull out of a cabinet designed for high security.  Nothing thrills a regulator
or auditor more than getting everything you ask for in a neatly labeled, giant 3-ring binder.
It says “PREPARED” in a way that having files on the network never will.

And, BTW, you HAVE completed all these steps – right?

For More Information, Contact Caroline Hamilton at caroline@riskandsecurityllc.com

What Happens if OCR Shows up – Asking about your HIPAA Compliance?

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With only 2 weeks (15 days) left to meet the HIPAA Omnibus Rule, let’s say you have
done everything you could possibly do, to be in full compliance with every part of HIPAA:

1.  Finish a current HIPAA Risk Analysis – CHECK
2.  Rewrite Business Associate agreements – CHECK
2.  Rewrite Policies & Procedures – CHECK
3.  Get PHI off the office copiers – CHECK
4.  Gather Documentation in one place – CHECK
5.  Start HIPAA Security Awareness Program – CHECK
6.  Update HR Sanctions Policies – CHECK
7.  Finalize Contingency Plans – CHECK
8.  Add more encryption – CHECK
9.  Implement Plan for Smartphones & Mobile  Devices – CHECK
10. Have staff sign new affirmation Agreements – CHECK

And in spite of your careful preparation, you walk into work on Monday, and the regulators from
OCR are sitting in the Lobby, and they’ve been there since 7:00 AM!

No matter what else you have done, or started, and have not done, your insurance policy is to be
able to pull out your most current (in months, not years) HIPAA Risk Analysis and then pull out all
your supporting documentation including:

1. All information, including network diagrams, on where the PHI is on your network, and the automated
network controls you have implemented.

2.  A record of every application, every database, etc. that hold PHI, are used to create, manage, or
share PHI, in both electronic and paper form.

2.  Rosters going back 3 years of everyone in the organization who’s taken HIPAA training.

3.  A copy of the Policies and Procedures, and Security Plans, printed out and labeled in 3-ring
Binders.

4.  List of all HIPAA controls that are currently in place and verification documents.

5.  Copies of all Business partners agreements and contracts

6.  A notarized statement signed by the Board Director, CEO or Administrator re-stating
the organization’s Commitment to HIPAA Security & Privacy & Omnibus Rules..

7.  Copies of recent employee surveys validating their stated compliance with all HIPAA
Security,  Privacy, and Omnibus rules.

All of these elements should be printed in their most current versions and put in D-Ring
binders, which you will pull out of a cabinet designed for high security.  Nothing thrills a regulator
or auditor more than getting everything you ask for in a neatly labeled, giant 3-ring binder.

It says “PREPARED”  in a way that having files on the network never will.

And, BTW, you HAVE completed all these steps – right?

 

 

 

 

HIPAA COUNTDOWN – 26 DAYS LEFT TO COMPLY WITH HIPAA OMNIBUS RULE!

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The HIPAA Countdown continues, with the HIPAA Omnibus Rule compliance date of September 23rd looming in the distance.

Now that everyone is coming back to work, relaxed from the long weekend (we hope), it’s time to get back to work.

As a HIPAA Risk Analysis expert, I have gotten more than 300 calls and emails in the last 5 days (yes, even on Sunday) about
what NEEDS to be done right now.   Here’s a sample of the questions,

“Should I do a penetration test before Sept 23rd?”
“Should we update our policies before Sept. 23rd?”
“Should I hurry and get the laptops encrypted by Sept 23rd?” 
“We re-wrote our business agreements – what else do I need to do before Sept. 23rd?

To quote Leon Rodriguez, the Director of the Department of Health and Human Services, Office of Civil Rights, which is
the lead federal agency for HIPAA Enforcement, “The Number One Thing you need to do before September 23rd
is to update, or start a new HIPAA Risk Analysis.”  

According to the OCR Guideline on Risk Analysis,  “Conducting a risk analysis is the first step in identifying and
implementing safeguards that comply with and carry out the standards and implementation specifications in the Security
Rule. Therefore, a risk analysis is foundational, and must be understood in detail before OCR can issue meaningful
guidance that specifically addresses safeguards and technologies that will best protect electronic health information.”

This is why the First Area that OCR will address when they visit is:  “Where is your HIPAA Risk Analysis?”

Where is yours?  And has it been updated lately?

And did you know that Leon Rodriguez is on Twitter!  His twitter handle is @OCRLeon.

 

 

 

Countdown for HIPAA — Less than 25 days to Deadline & How to Get A Free HIPAA Risk Analysis Guide

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NEW DEADLINE:  September 23, 2013

The new HIPAA Omnibus rule became law on March 23, 2013.   The main provisions of the Rule, which include new requirements for healthcare organizations, insurance companies, hospitals, clinics, pharmacies, dental practices and many other organizations, also include Business Associates, which means any organization that has access to patient medical records (PHI- Protected Health Information).

So all the data managers, the data storage companies, the lawyers and countless other companies who are part of flow of healthcare and medical data also have to have a completed HIPAA Risk Analysis by September 23, 2013!

For primary healthcare providers, to be in compliance with the HIPAA Omnibus Rule, they have to revise all their policies and procedures, and also rewrite their contracts with business associates, to place responsibility for data protection on the business associates. And business associates have to apply the same policies to their subcontractors too.  So thousands of policies and contracts are being furiously re-written, as I write this!

Completing a  HIPAA Risk Analysis is the best way to prepare for the deadline, and also to pinpoint any area where your organization needs to
improve a control, a policy or their operating procedures.   As a core HIPAA requirement, the Risk Analysis is a kind of summary of where the organization is in relation to all the HIPAA Rules, including HIPAA Privacy, HIPAA Security, NIST SP 800-66, the Office of Civil Rights, and the
Breach Notification Act.

There are great software tools available to help managers do a HIPAA Risk Analysis (like my HIPAA Risk-Pro program), available online at
www.flash-risk.com, or, as another option, many other organizations are hiring HIPAA consultants to come in and do a Risk Analysis for them.

So if you are a healthcare organization, or a designated business associate, you can start your HIPAA Risk Analysis on Tuesday, Sept. 3,
and have it completed by the deadline.

The Office of Civil Rights has a big pot of money, collected from fines, and they have hired more investigators to go out and audit all these organizations for HIPAA Compliance.  Recently a small hospice in Idaho was fined $50,000, and a physicians practice in Arizona was fined $100,000, and
many other organizations, including states and health plans, have been fined more than $1,000,000 for a variety of violations, including not
having a current Risk Analysis.

For more information on how to do a HIPAA Risk Analysis, you can write to:  info@riskandsecurityllc.com and get a free HIPAA Risk Analysis Guide, a free Project Plan, and a copy of exactly what the OCR Regulators look for when they conduct a HIPAA audit.

 

Why HIPAA Compliance is Related to Federal Contracts

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Most healthcare organizations take Federal money – whether it’s reimbursement for Medicare services, or if it’s a federal grant for
providing special care or even addiction treatments, or whether they are part of an NIH trial, or receiving grant money for research.

If your organization is part of state government, county government or even city government, your organization probably takes federal money too.

When the hospital, clinic or treatment center gets that Federal check, they have to first sign a contract saying they verify that they are in compliance WITH ALL FEDERAL LAWS, RULES AND GUIDELINES.  In the old days, this may have meant that you didn’t discriminate in your hiring policies, or that you complied with the Americans with Disabilities Act (ADA), or that you complied with federal reporting requirements, like for a GSA Contract, or for billing protocols.

But HIPAA is also a law, and a Federal Rule, and so when you signed that contract, you attested, or ‘represented’ that your organization was in compliance with all the HIPAA laws and rules, too.

I recently talked to a CEO of a large hospital that, as a Level 1 trauma center, received millions of dollars each year from the Federal government – and he wasn’t aware of their HIPAA status!  He didn’t know if a HIPAA risk analysis had been done (it hadn’t), or whether they had amended all their business associate agreements (hadn’t even started), and also had no idea that some of these HIPAA Rules had elements that needed to be formally approved by the Board.

If you’re the HIPAA Compliance Officer, the Privacy Officer, the Information Security Officer, or any functional title that means, the HIPAA Buck stop with you — you need to explain this to your manager or director.  This will get any administrator’s attention, because they don’t want to have to give any of that money back, and they also don’t want to get into a lawsuit over a compliance issue.

So keep talking about that HIPAA Compliance deadline of September 23, 2013, and you’ll get the support you need, and maybe the budget you need to keep all your HIPAA activities in full swing!

 

How to Easily Update your HIPAA Business Associate Agreements Before Sept. 23, 2013

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One of the major changes for every business involved with the new HIPAA Omnibus Rule is that you are required to 
“Review and,  if Necessary, Amend Business Associate Agreements”
Whether your organization is defined as a Hospital, a Physician Practice, a Group Health Plan, a Managed Care organization, a Pharmacy, a Dental Office, or any kind of “Covered Entity” (CE), you have to change your business agreements with all the people who access, create, manage, store, or view your Protected Health Information (PHI).
The new HIPAA Omnibus Rule (45 CFR § 164.314(a) and .504(e)) added new elements that require you to adjust the Business Associate agreements to make sure they agree (in writing) to comply with the HIPAA Security Rule, to make sure they perform their own Risk Analysis to assess how they protect PHI.
Covered entities and business associates must ensure that their existing and future agreements contain the elements required by . In addition to previous requirements, the agreement must require the business associate to:


1.  Comply with the security rule.

2.  Execute business associate agreements with their subcontractors. 

3.  To the extent the business associate carries out an obligation of a covered entity, comply with any HIPAA
      rule applicable to such obligations.

4.  Report breaches of unsecured protected health information to the covered entity (organization).
If you’re not sure how to adjust all these agreement, DHHS-OCR has updated sample business associate language for you
to use at :  http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/contractprov.html.

The HIPAA Omnibus Rule has made accountability more important because it says that the Covered Entity (CE) is

are liable for the misconduct of business associates if the business associate is acting as the agent of the covered entity.

In the same way, business associates should review their agreements with their Covered Entities and also their Sub-Contractors to make sure that the language in their contracts is up to date and makes it clear that the subcontractors are acting as independent contractors and not as the agents of the covered entity or business associate, and that the agreements do not give the covered entity too much control over day-to-day operations of you, their business associate.

As of today, August 19, 2013, both the Healthcare Provider (CEs), and the Business Associates have 34 more Days to modify these agreements modified and up to date, making sure they match the new HIPAA Omnibus Rule if :

(1) the agreement they had in place on January 25, 2013, complied with the HIPAA rules as of that date, and

(2) the agreement does not expire or renew (other than through evergreen clauses) prior to September 23, 2014!

So get out those pencils, and those agreements and start reviewing, amending and modifying those agreements!
SPECIAL TIP:  Here’s a web site with sample Business Associate language to use as a resource:
  http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/contractprov.html