OCR Settlement

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

Posted on September 8, 2013 2:09 pm by Caroline Ramsey-Hamilton Comment

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!

Posted on September 4, 2013 11:39 am by Caroline Ramsey-Hamilton Comment

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.

Photocopier Misuse Triggers $1.2 Million Dollar Fine for Affinity Health

Posted on August 15, 2013 1:39 pm by Caroline Ramsey-Hamilton Comment

A HIPAA fine of $1,215,780 has been assessed against Affinity Health Plan, a not-for-profit managed care plan serving the New York metropolitan area. The Settlement was announced on August 14, 2013 at 11 pm.

This is the first settlement involving a copier. Affinity Health Plan had a copier that they returned to the vendor, and it was re-sold to CBS Evening News, without erasing all the files that the printer had stored for year.

CBS News found that the hard drive of the used copier contained health records of The new copier owner found the files and it was determined that over 344,579 individuals had their Protected Health Information exposed by the Breach, which was initially reported in April of 2010.

Affinity impermissibly disclosed the protected health information of these affected individuals when it returned multiple photocopiers to leasing agents without erasing the data contained on the copier hard drives. In addition, the investigation revealed that Affinity failed to incorporate the electronic protected health information (ePHI) stored on photocopier hard drives in its analysis of risks and vulnerabilities as required by the Security Rule, and failed to implement policies and procedures when returning the photocopiers to its leasing agents.

In addition to the $1,215,780 payment, the settlement includes a corrective action plan requiring Affinity to use its best efforts to retrieve all hard drives that were contained on photocopiers previously leased by the plan that remain in the possession of the leasing agent, and to take certain measures to safeguard all ePHI.

The settlement included violations of both the HIPAA Privacy and HIPAA Security Rule. Increases in audits and, subsequently, fines at other healthcare organizations are expected to increase after the new HIPAA Omnibus Rule goes into effect on September 23, 2013.

To read the entire Department of Health and Human Servies (HHS) Resolution Agreement and Corrective Action Plan can be found on the OCR website at http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/affinity-agreement.html.