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HIPAA

Why HIPAA Risks are Growing Every Day

Posted on June 26, 2013 10:24 am by Caroline Ramsey-Hamilton Comment

If you’re a healthcare employee, you already know alot about the HIPAA Rules. You’ve probably received training on how to protect Health information, and have heard about all the fines being levied against everything from small hospices to the largest hospitals (like Massachusetts General Hospital).
Because HIPAA is a federal law, there are expensive penalties involved in HIPAA mistakes (breaches). Fines have ranged from millions of dollars to $50,000. Here are just a few of the recent fines.

Shasta Regional Medical Center –            $ 275,000, June 2013

Hospice of Northern Idaho                         $ 50,000, January, 2013

BCBS Tennesee –                                 $ 1,500,000 March 2013

State of Alaska –                                   $ 1,700,000, June 2012

Phoenix Cardiac Surgery –                        $ 100,000 April 2012

Mass General Hospital –                         $ 1,000,000 February 2011

There have been dozens of other fines, many in the millions of dollars, and, with the passage of the new HIPAA Omnibus Rule, which takes effect on September 24, 2013, there will be many more.

If you are a healthcare organization, you need to address the risk of a potential HIPAA Fine. And the fines not the worst part, because the “resolution agreement” you sign, forces your organization to file all sorts of quarterly reports, meet with regulators for years to come, and those ongoing activites are even more expensive than the fine!

The Office of Civil Rights (part of the U.S. Dept. of Health and Human Services), is self-funded from these fines, and they use the money from the fines to start even MORE enforcement activities.

The basics you need to have in place to reduce the risk of a HIPAA fine include 1) having a Risk Analysis done in the past 12 months, 2) having HIPAA Training conducted annually for EVERY employee, 3) Updating all your Business Associate agreements, 4) developing a robust security awareness program, just to name a few.

HIPAA compliance-related fines are a risk that should be considered by every healthcare organization, no matter how big or how small, because your bottom line, AND your reputation may depend on it!

 



Why the HIPAA Risk Analysis should be finished by December 31, 2012

Posted on September 4, 2012 1:48 pm by Caroline Ramsey-Hamilton Comment

The federal regulators from the U.S. Department of Health and Human Services are from the Office of Civil Rights.  They think that breaches in patient information protection is a violation of the patient’s civil right!   Regulators commonly assess fees for non-compliance and some are as high as $4 milion dollars.

Because the OCR just came out with new Audit Guidelines this summer (email me and I’ll send you a copy), we all can see that the visits to healthcare organizations are still speeding up, and even more rules are coming this fall as they reconcile the HIPAA Security Rule with the HIPAA Privacy Rule with the Breach Notification Rule.  I call this:  MEGA HIPAA!

Because the current HIPAA rules have been in place for over ten years, and because the new Rules may be much more complex, it makes sense to finish your 2012 HIPAA Risk Analysis for either Security or Privacy, or both, before December 31, 2012.

My experience with federal regulators and auditors leads me to believe that a HIPAA Security Risk Analysis that is finished before the end of this calendar year will go a long way in reassuring regulators that there is, at least, a formal process in place to assess the risks to patient medical information.

A new software program is based on my original free Data Collection Guide,and can be used to complete these important security rules at a fraction of the cost of older, out-of-date risk analysis programs. Or do it on a spreadsheet.

Remember, you can also use it in your Meaningful Use Risk Assessment.  A two-for-one.

My advice:  Take the easy way out.  Finish the Risk Analysis!

 

 



Outlook on Risk & Security Compliance in 2012 – What to Expect.

Posted on January 1, 2012 6:59 pm by Caroline Ramsey-Hamilton Comment

This New Year’s Eve, I thought at times my neighbors were using a rocket launcher and several assault rifles to shoot up the New Year.  Lucky for me,  I spent the awake time to contemplate the outlook for risk, threat and security issues for 2012 and here’s what I see for 2012.

1.  Government-Mandated Compliance Is Here to Stay for the Healthcare Industry.

I remember when the IT departments are many hospitals thought George W. was going to revoke the HIPAA Security Rule.  It never happened, and this year, for the first time, there is a regulatory body in place that is intent on REAL ENFORCEMENT.

The Dept. of Health & Human Services, Office of Civil Rights,  has expanded HIPAA Security and Privacy Rules to include “Business Associates” including lawyers working in healthcare, and the infamous “3rd Party Providers” who do everything from warehouse data to taking over the IT function of a hospital, and this trend will continue as pressure builds from consumers who’s medical and financial data continues to be compromised.

2.  Workplace Violence Prevention will become an OSHA mandate, if not in 2012, at least by 2015.  Based on the slug-like pace of OSHA, who only recently provided directives for high risk industries, and the pressure from the more than 30 states who have passed their own regulations,  the pressure to stop the number of incidents and to lower their intensities will increase and management will be forced to address it as a major corporate issue.

3.  Pressure on the financial industry to protect consumer information will increase.  Like many other areas, pressure is increasing to prevent the enormous data breaches we saw in 2011, like Tricare, the recent Stratfor hack by Anonymous, Wikileaks and HealthNet breaches.  Consumers are the squeaky wheel and they want the convenience of plastic and internet use, and they will not tolerate breaches, and they are all registered voters!

The FFIEC has already tightened up on both risk assessment standards, as well as
authentication guidelines for all financial institutions.

 

There will be a increase in requirements for risk assessment as an accountability feature to force managers to maintain better security in all areas of their organizations. 

Accountability means that individual managers will be held responsible for the decisions they make regarding other people’s:

1.  Financial Data

2.  Medical Records

3.  Safety from both Violence & Bullying in their workplaces.

Budgets can be cut, and staff can be reduced but consumers are demanding protection of their information, and themselves, and the regulators will make sure they get it in 2012!



HAS 60 MINUTES EXPOSED THE SEC SECRET – No Penalties for Big Banks?

Posted on December 5, 2011 5:06 pm by Caroline Ramsey-Hamilton Comment

On Sunday evening, December 5th,  60 MINUTES aired what I think is a ground-breaking bit of investigative reporting on how the SEC allowed big banks and mortgage companies to violate Sarbanes Oxley (SOX) requirements with total impunity.

Since the American public is still suffering from the mortgage meltdown – they are looking for answers and looking for punishment.  Crime and punishment usually go together in the Justice Department and law enforcement communities.

“You do the Crime – You do the Time”.

So one person is arrested for a victimless crime, like shoplifting a candy bar, but a big company, like Countrywide, or Bank of America, can crash a worldwide economy, lie on federal forms, commit perjury and saw intense financial destruction to millions of people, and they are allowed to keep the fortunes they made through this risky behavior, and, even better, there’s no jail time, no fines commensurate with crime, and no penalty for openly flaunting federal laws!!

WOW – what kind of message does this send?

For me, concerned day after day with helping organizations comply with federal mandates and laws, like SOX, and HIPAA, and OSHA, this makes a parody of compliance enforcement.

Companies spend millions of dollars to comply with these regulations, which are passed to protect the American public from exactly what just happened.  To find that the regulators are the ones who ignored the falsified attestations, forgave the lack of compliance and let these 21st century robber barons keep their ill-gotten gains makes me, and about 200 million other people, sick!

 



Why Bother with a HIPAA Risk Analysis Anyway?

Posted on October 6, 2011 3:30 pm by Caroline Ramsey-Hamilton Comment

People tell me all the time that their management doesn’t want them to do a risk analysis, even if it’s a requirement.  Sometime they say that they have no budget
to fix anything – so why bother?

Even if it’s a requirement, like new workplace violence assessments, or a federal law like the required HIPAA risk analysis, there are people who want to do it in 30 minutes in a spreadsheet, without conferring with other staff members, without bothering to do a walk-through of the facility, without management’s enthusiastic support.

Here is a list of good reasons to do a Risk Analysis for HIPAA, even if you are not sure about whether you need it or not:

1.   It’s a Federal law.   It’s possible that no one will know if you don’t do it, but
      what if you have a MassGeneral-style data breach next week?

2.   It saves the organization BIG BUCKS, by doing the cost benefit analysis so
      the IT department can implement controls that actually increase protection
      AND reduce potential threats at the same time.

3.   A Risk Analysis acts like a security awareness training program if you
      involve the entire hospital or healthcare staff.  Many times they aren’t
      aware of the policies and procedures, and having them answer the
      HIPAA compliance surveys is a great no-cost refresher cost.

4.   You can uncover REAL vulnerabilities and fix them right away.  For example,
      you may not know who’s taking your database home on their unencrypted
      laptop.   You may not know that only 20% of the hospital staff took time to
      take the online training!  This lets your IDENTIFY problems and FIX them.

5.   It instantly makes the security analyst/information security officer the
      SMARTEST person in the room.  You know understand everything about
      protection of medical records in your organization!

6.   Regulators are getting CASH BONUSES for finding problems.  Don’t let
      them vacation in the south of France because they found a vulnerability
      in your IT systems!

Start your risk analysis today – and I will make sure YOU get all the credit!



Using Risk Assessments as a Business Process

Posted on June 21, 2011 1:43 am by Caroline Ramsey-Hamilton Comment

Risk assessments are increasing in utility and popularity – being used for everything from compliance to safety assessments, and used by financial institutions, healthcare organizations, manufacturers, government of the world and think tanks. 

Many regulators require formal risk assessments on everything from gauging political risk in an unstable country, to protecting consumer financial information, to assessing workplace violence potential.  

Here’s a definition of a risk assessment:   A process to determine what controls are necessary to protect sensitive or critical assets both adequately and cost-effectively. Cost effectiveness and Return On Investment (ROI) are required elements of a risk assessment.  

A risk assessment is not a democratic process where the most popular answer wins.  It is not consensus driven.  Instead, it is a business process that manages a security function.   Security is very process centered.  Because security often consists of many different elements which are critically important, such as managing network access,   it makes sense to manage it as a process.

According to the statistics, risk assessments are way up in popularity in 2011.  Maybe
it’s economics – maybe it’s result of the previous economic downturn, but the requirements for risk assessments have never been broader, and there have never been more of them than there are now.  Here’s a partial list:  

The Joint Commission
HIPAA, HITECH, NIST 800-66
FFIEC, BSA-AML,
ISO 27001 and 27000 series; NIST 800-53
Red Flags Identity Theft
NCUA Part 748
FEMA 426, FEMA 428

The exercise of doing a risk assessment affords a level of protection which is related to how many other people actually contribute to the risk assessment results.   Using an online compliance survey as a participatory measure takes the onus of absolute responsibility away from the manager/analyst and distributes it throughout the organization where it belongs.

Obviously people are a critical component of information security.  In a risk assessment, people are also important to include because they are able to report what’s going on in their workplace every day.  How can one analyst know enough to do the entire risk assessment by themselves?  They would have to be everywhere at once – in the morning, late at night, on the weekends, and also be able to channel the work of everyone from the newest tech support person to the director of the data center.   And the inclusion of a variety of individuals adds weight and power to the risk assessment.

The true value of the risk assessment is in the cost benefit analysis, which details what controls need to be implemented, how much they cost and how much they would protect the organization by either prevent threats from occurring or by mitigating the impact of the incident if it occurs. 

While the analysts may be accountable for the reporting or analysis of potential risk, the responsibility for any action that needs to be taken is up at the C level, or with the Board of Directors.  In fact, in the FFIEC IT (Federal Financial Institutions Examination Council Information Technology ) Handbook, they spell out, “The Board is responsible for holding senior management accountable”.  Often we have found that the actual President of a bank or credit union doesn’t always KNOW that he is going to be held responsible – this information is down another level in the organization.

I recommend getting management to sign off on the basic assumptions,  in writing,  in the course of completing the risk assessment – and of course, on the final reports. Areas where senior management can review and approve include: 

  • Calculation of asset values, including the value of the organization in total
  • The potential costs of implementing different controls, singly or in combination.
  • Validating which controls are currently in place and how well they are working.
  • The conclusions from the draft report, and the final report.

The analyst is just the messenger, doing the work of assembling the risk elements and calculating their potential results.  But senior management makes the final decisions on each element.   There’s nothing like a signature on a piece of paper to foster a climate of accountability. 

Risk Assessments have the potential to save corporations and governments millions of dollars by making decision-making based on real analytics, instead of just guesses – plus they are an essential element of compliance.  These are good reasons to evaluate whether it’s time for you to do a Risk Assessment!



Using a Project Plan for your HIPAA Risk Analysis

Posted on June 4, 2011 1:16 am by Caroline Ramsey-Hamilton Comment

When HIPAA first became a law, at the end of 1997, most healthcare organizations were so sure that it would be repealed or rescinded when Bush came into office, that they never quite got around to doing that first risk analysis.

Later, the risk analysis requirement got harder and tougher, when the Office of Civil Rights (OCR) added their guidance document in May 2010, and suggested that in addition to HIPAA Security and HIPAA Privacy, and the HITECH ACT, that organizations should also use NIST Special Publication 800-66 as a reference guide for the risk analysis and the protection of electronic Protected Health Information (ePHI).

The risk analysis has gotten more complicated, by the tightening of requirements, and by the need to include business associates, third party vendors, and an all-hazards threat approach.

Using a detailed project plan as you start the risk analysis is a good way to not only deal with the technical requirements, but also to inform management and stakeholders in the organization what a risk analysis includes, and to outline their potential participation.

There are different roles including IT users who will answer questions related to HIPAA control standards, management who will provide financial data and approve different values, and department managers, who will supervise their own staff and make sure they answer the surveys and cooperate with the analyst in a timely manner.

After the roles have been assigned, the data gathered, the reports approved, the project plan can be used to create the mitigation activites, a corrective action plan, and used to manage and track the new controls that are implemented.

If you’d like to see a HIPAA Project Plan, just email me at chamilton@riskwatch.com

 

 

 

 

 

 

 

 



The Risk Assessment – Live – and Cross-Cultural

Posted on October 25, 2010 8:00 pm by Caroline Ramsey-Hamilton Comment

I just got back from a great trip to the Middle East.  I spoke at a State Department conference (ISAC) Conference in Doha, Qatar and then did a full risk assessment of a large hospital in Abu Dhabi.   Besides that I loved the food, and loved the people, and came home with lots of beautiful earrings and bangles and perfume.

The great insight I got on this trip was that security problems are exactly the same everywhere… they are not based on sex, race, nationality, gender, religion, hair color, height,  politics, or anything else.   Maybe this is why the TV show “The Office” is a worldwide hit.   Organizations work the same way all over the world.  As a person who got her degree in cultural anthropology of all things — I am amazed less at the differences than I am in the similarities between organizations.

This is my 17th country that I have visited to do a security risk assessment and they all come down to these basic steps: 

1.  Identify what you want to assess.   Many times you need to cut down the proposed assessment, it doesn’t need to include things that are 10 miles away.

 2.  Write up a Project Plan to show other people what you’re doing to do – and give management a time line to work with.  (It keeps me focused – a value add).

3.  Find the dollar VALUE for whatever you are assessing, for example — How much is the facility worth?   What’s the value of one patient record – two dollars or two thousand dollars?

4.  Come up with a realistic threat profile that includes the local crime rate, some historical data for crime, cyber crime, natural disasters, fire, etc.

 5.   Ask other people in the organization how they handle security.   I like using our automated surveys because it captures more immediate data from individuals.  You can use a translator if you don’t speak the language and I guarantee you’ll be amazed at the results.  The more people you interview – the more amazing the results will be.

6.   Examine all the existing controls and see how they are being used in other areas of the organization,  are they 100% implemented?   80%?   50?  Even less?

7.  Analyze the results with good math.  This is commonly done by software, but you can also use a regression analysis model with a database program like Access –   don’t guess.    Let the numbers do the talking.

8.   Write up a simple report, illustrated with lots of color graphs and photos, so someone  can just page through the report and understand what the assessment revealed.

The best risk assessment report in the world is a waste unless it comes up with actionable results — the list of what the organization needs to do NEXT.  Some people call them After Action Reports, maybe they are called Corrective Action Reports, maybe they are called a Task List.  The name doesn’t matter, but the results matter.

The report should cover the basics of what you did, what areas you reviewed, who you talked to (or got answers from with a survey), and what you recommend should be done, based exactly on the risk assessment.  In banking and financial companies, the regulators already get the last risk assessment and ask the organization to show “where in the risk assessment did it say you should add a stronger firewall?  add a better camera system to the Emergency Department?  do background checks when you hire new people?

These are just examples,  any improved control could be used – but you will need to show the regulator exactly WHERE in the risk assessment it said you should do this or that.     In the follow up Blog – I’ll talk about how to present your findings to your management.



All about the HIPAA Risk Analysis — from the Department of Health & Human Services Office of Civil Rights (OCR).

Posted on May 16, 2010 8:24 pm by Caroline Ramsey-Hamilton Comment

An amazing development in HIPAA compliance took place on May 7th.  What a great surprise for a Risk Analysis/Risk Assessment Person!  The Department of Health and Human Services, Office of Civil Rights finally came out with their draft guideline for the HIPAA Risk Analysis on May 7th!

While hospitals and health plans, business associates, technical service providers and physicians have struggled to understand the original HIPAA risk analysis requirement, the Health & Human Services Department finally published the draft guidance to help healthcare providers understand what is expected of them in doing a risk analysis of their protected patient health information (ePHI).

This is a critical part of the HIPAA Security Rule, but there was never any ‘official’ guidance of exactly what was expected and how they should accomplish the risk analysis. 

Why the Office of Civil Rights?  Because the new HITECH Act (February 2010) directed that OCR oversee health information privacy including the enforcement of the HIPAA requirement.   And the guidance is long overdue.  I have had dozens of conversations with individuals at hospital and, discussing what a risk analysis is, what are the basic elements, and I am THRILLED to report that the OCR agrees with my methodology.

 The draft guideline on risk analysis also takes the same track that the financial institutions have given as guidance to banks and credit unions.  That is risk analysis is a foundational document that should be used (and referenced) as the organization evaluates and implements appropriate controls.

OCR refers to the risk analysis, not as a one-time drill, but instead, as an ongoing process to help organizations evaluate their risk focusing on the confidentiality, integrity and availability of protected health information.  The Risk Analysis Report, creates the blueprint that an organization will follow as they improve their compliance – for example, deciding what data should be authenticated in particular situations, deciding, when, if or how to use data.

A risk analysis is also the basis for an understanding by organizations of the technologies they will need to secure protected health information, OCR said in the draft guidance May 7. 

To quote directly:  “We begin the series with the risk analysis requirement in § 164.308(a)(1)(ii)(A).  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.”

Among the basic elements of a risk analysis, OCR said, organizations must identify data collections, document threats to information that could create a potential for inappropriate disclosure and assess current security measures the organization uses to protect patient information. This was great to read because it follows the elements I have built our solutions around.

Those elements, which were reinforced by the draft guideline include the following five elements of risk analysis (and risk assessment).

1.     Identify and characterize the assets that need protection,  including the databases, the applications, etc.

2.    Analyzing the relevant threat data – focusing on what could adversely affect the assets (ePHI) in this case.

3.    Modeling the potential losses that could result from the threat actually materializing.

4.    Finding the existing vulnerabilities in the current security situation that would increase the odds of the loss actually occurring.

5.   Developing appropriate controls to reduce potential loss, reduce existing vulnerabilities and make sure the controls are cost effective.

 The OCR also referenced the NIST 800-66 to show sample questions that need to be part of the risk analysis.  Luckily – we totally agree with them and have included the NIST 800-66 Guidance in every HIPAA Risk Analysis software solution.

 Here’s another short excerpt from the OCR:

 “Risk Analysis Requirements under the Security Rule

 The Security Management Process standard in the Security Rule requires organizations to “[i]mplement policies and procedures to prevent, detect, contain, and correct security violations.” (45 C.F.R. § 164.308(a)(1).)  

Risk analysis is one of four required implementation specifications that provide instructions to implement the Security Management Process standard.  Section 164.308(a)(1)(ii)(A) states:

RISK ANALYSIS (Required).

Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the [organization].

OCR went on to cite NIST 800-66:  “The following questions adapted from NIST Special Publication (SP) 800-66  are examples  organizations could consider as part of a risk analysis. These sample questions are not prescriptive and merely identify issues an organization may wish to consider in implementing the Security Rule:    Have you identified the e-PHI within your organization? This includes e-PHI that you create, receive, maintain or transmit.    What are the external sources of e-PHI?

The publication of this first draft guideline gives healthcare organizations and other affected organizations a hint about which direction the OCR enforcement is going to go.  As I mentioned previously, the regulators are likely to follow the example of financial audits and ask for the current copy of the organization’s risk analysis and use that as the blueprint to measure how well the organization used the risk analysis to prescribe and dictate all other actions which were taken to protection the organization’s protected health information.

In the words of the OCR –

“In Summary, Risk analysis is the first step in an organization’s Security Rule compliance efforts. Risk analysis is an ongoing process that should provide the organization with a detailed understanding of the risks to the confidentiality, integrity, and availability of e-PHI.

For a complete copy of the 8 page OCR guideline, please send an email to chamilton@riskwatch.com.

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Want to see MY Medical Records?? No Problem.

Posted on February 15, 2010 6:25 pm by Caroline Ramsey-Hamilton Comment

The fury and passion devoted to protecting medical records is totally incomprehensible to me. 

Who wouldn’t want their med records to be immediately available in case of  an emergency?   I have a twinge ( as opposed to a tweet) every time I go to my doc’s office and see his color-coded manila folder filing system.  It is a nightmare, but it doesn’t seem to bother the nurses.  

I understand that if someone had AIDS, they might not want their boss to know about it. But how many people reading this have AIDS (3/100 ths of a percent), based on U.S. Census Data (309 million Americans) and number of Americans afflicted (1 million). So could not be the only reason. 

I understand why not to disclosure STD’s.   What else?  I thought about my medical record and how bare and boring it is.   I’ll be happy to tell you all about it.  Here are the highlights:

     Had Scarlet Fever when I was about 11 years old.  I was lucky – no side effects, but my sister lost her hearing in one ear.

     Broke my right ankle in ballet class when I came down on the wrong angle after a SPECTACULAR tour jete!  I’m proud of that one.

     Got kicked by a pony near my left ankle when I was in my 40s.  Didn’t break anything, but insurance company put MY ANKLE on the list of NON-COVERED areas. LOL

    One dog bite from a German Shepard when I was college.  It was an accident.
    We were playing grab-it with a toy…

     Used to get bronchitis fairly regularly when I smoked, which was over twenty-five years ago.

     Had tubes tied after 2nd son.

     Had an eye lift – cosmetic surgery – Hurrah….

Pretty scintillating stuff!   You can see why I don’t worry about anyone getting their hands on my medical records.    I don’t even care about any of this – why would anyone else?  

I got another view of the medical record problem when my sister was diagnosed with a brain tumor.  HER medical records were enormous and included things I had never seen before like 3-D rotating images of her brain so doctor could turn it around and view it from any angle.  Her records were so complex that we literally had to take a set of CD’s to office visits.  Didn’t make any difference, she died four months later.

The cost of converting my boring records is something else I wanted to check out.  For a small doctors office with 3 doctors – installing a full document management system would cost about $100,000 with an annual maintenance fee of $30-50,000.  Quite an initial investment for a small office.

Here are some fun stats on paper records, from a Coopers Lybrand survey on the time and money spent on paper in today’s typical organization:

• Of all the pages that get handled each day in the average office, 90 percent are merely shuffled. 

.   The average document gets copied 9 times. 

• Companies spend $20 in labor to file a document, $20 in labor to find a misfiled document, and $220 in labor to reproduce a lost document.

.  7.5 percent of all documents get lost, 3 percent of the remainder get misfiled.  

• Professionals spend 5-5 percent of their time reading information, and up to 50 percent of their time looking for it.  

• There are over 4 trillion paper documents in the U.S. alone – growing at a rate of 22 percent per year. 

The famous Google Health project will digitize your medical records and put it in their repository for free, BUT you have to get them from your doctor in digital form first. 

And to see how mainstream this concept is going – there’s now an App for that! Yes, if you have an iphone you can get Health Cloud for free!  

But now that I have published my medical records on Twitter, or at least, my summary of my medical record – the whole world can have access!




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