Jon Tomes
In the first enforcement action announced in 2020, the Department of Health and Human Services (“HHS”) has settled with Dr. Stephen A. Porter for $100,000 and entry into a corrective action plan (“CAP”) for alleged HIPAA violations. See https://www.hhs.gov/sites/default/files/porter-ra-cap-508.pdf . The matter arose because the doctor, a gastroenterologist, had his access to his company’s electronic protected health information (“EPHI”) blocked by his electronic medical record company until he paid the company $50,000. Pretty bad when your electronic health record (“EHR”) company engages in a form of ransomware.
The investigation by the HHS Office for Civil Rights (“OCR”) revealed that Dr. Porter had failed to conduct a risk analysis to identify risks to the confidentiality, integrity, and availability of EPHI in violation of 45 C.F.R. § 164.308(a)(1)(i), had not reduced risks to a reasonable and appropriate level, and had not implemented policies and procedures to prevent, detect, contain, and correct security violations. Since at least 2013, the practice had allowed Dr. Porter’s EHR company to create, receive, maintain, or transmit EPHI on behalf of the practice, without entering into a business associate agreement, in violation of 45 C.F.R. § 164.
In my writings, seminars, webinars, teleconferences, and onsite consulting trips, I have always responded to comments by those from small practices that they would be too small for HHS to sanction for a HIPAA violation with one word. Wrong. This case is yet another one (and maybe the smallest practice to date) that proves my point. Yes, maybe HHS will not choose a small practice for an audit, but if there is a breach that must be reported to the so-called “Wall of Shame” of HHS, the resulting investigation will look at the entire state of HIPAA compliance of the affected entity, regardless of size.
And can you trust your EHR company? Really? How do you know? Do you have a compliant business associate agreement in place? Does your EHR company have proof of HIPAA compliance? Is it current?
Alice here: Yes, once again, I am here to try to sell things to keep you and us in business. Surely, after having read Jon’s blog items all these years, and especially today’s blog item, you recognize that you must keep your risk analysis up to date. Make sure that you include malware and ransomware in your initial risk analysis and all updates thereof. If you need help with your risk analysis, either initially or for an update, Jon Tomes has written a Risk Analysis ToolKit to provide the structure and tools to help you complete the requirement under HIPAA. You and your risk analysis team can fill it out and document your decisions as to what is reasonable and appropriate for you to adopt in the way of policies and procedures and be done with it. Or you could send your completed risk analysis to Jon to review and render his professional opinion as the country’s leading HIPAA expert (IMHO) as to whether it is sufficient to keep you from getting that free trip to Leavenworth or that very expensive trip to the bank. If you have Jon’s Compliance Guide to HIPAA and the DHHS Regulations, 6th edition, with the accompanying HIPAA Documents Resources Center CD, also 6th edition, you can find the Risk Analysis ToolKit on the CD. It is also available with a review by Jon at https://www.veteranspress.com/product/hipaa-risk-analysis-toolkit. Also, Jon Tomes presented a webinar recently on “How to Do a HIPAA and HITECH Risk Analysis.” You can buy a recording of it at https://www.complianceiq.com/trainings/LiveWebinar/2255/how-to-do-a-hipaa-and-hitech-risk-analysis. Jon is also writing a Risk Analysis Update ToolKit, which will be available for you in the near future on the Premium Member section of our website. Please stay tuned for our announcement when it is up and running for you there. Also, include in your risk analysis the lack of a business associate agreement if you are considering hiring a business associate or a downstream business associate. Please also note that Jon has audited a number of business associates so that they can demonstrate their reliability by showing prospective customers EMR Legal’s Certificate of HIPAA Compliance.
If you need guidance on how to draft the policies and procedures that your risk analysis or your newly updated risk analysis has shown are reasonable and appropriate for your organization, Jon has also written The Complete HIPAA Policies and Procedures Guide, with the accompanying CD of several dozen HIPAA policies and procedures templates for you to adapt to your situation, including a release of information policy and a right of access policy. That book also contains a chapter by me on how to write in general, but more specifically on how to write a good policy.
Make sure that you train your entire workforce on HIPAA in general and on the HIPAA policies and procedures according to who needs to know what to perform their duties for you. If you need handy HIPAA training in general, consider Jon’s training video and training manual in either of two forms available here: https://www.veteranspress.com/product/basic-hipaa-training-video-dvd-workbook or https://www.veteranspress.com/product/online-hipaa-training-video-certification. Or you could hire Jon to present HIPAA training onsite to your workforce. Just contact him at jon@veteranspress.com or 816-527-3858.
Keep your written documentation of all of these HIPAA compliance efforts where you can find them easily and quickly, after restarting your heart, if HHS shows up demanding your HIPAA compliance documentation. We recommend keeping all of it in Jon’s Your Happy HIPAA Book. Jon included tabs in the three-ring binder for everything that you need to document and a checklist for each tab. I recommend adding the date that you check off each item in each checklist, as one of our clients suggested to us.
If you have had a security incident that you were unsure as to what exactly to do about, or if you are concerned that you may have one, consider reading Jon’s book How to Handle HIPAA and HITECH Act Breaches, Complaints, and Investigations: Everything You Need to Know.
A sample business associate agreement policy and a sample business associate agreement are posted in the Premium Member section of our website at www.veteranspress.com.
As always, thanks for reading Jon’s blog, buying his books and other HIPAA compliance tools, attending our seminars and webinars, and hiring Jon for HIPAA consulting and training. We wish you every success with your HIPAA compliance efforts. Please avoid the coronavirus with or without the HIPAA implications. We need you on the planet just the way you are to do the work that you do. Thank you. Happy St. Patrick’s Day!
