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OCR Mic Drops With 12 Cases – Ep 366 

 July 29, 2022

By  Donna Grindle

OCR investigationsOCR recently announced the resolution of 12 investigations. Eleven were for patient right of access violations and one was a big dollar settlement of a security incident at Oklahoma State University Center for Health Services. Lots to cover and learn in this episode. So, pay attention, folks.

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In this episode:

OCR Mic Drops With 12 Cases – Ep 366

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HIPAA Say What!?!

[08:27] The HIPAA Security Rule 45 CFR 164.306(a)(2) says: Protect against any reasonably anticipated threats or hazards to the security or integrity of such information.

Often people don’t quite understand what “reasonably anticipated threats” means. Basically, it’s security threats, alerts, notices, etc that you may hear or read about in the news or online or even hear on podcasts like ours. Here are two recent examples, one is a CISA joint cybersecurity advisory bulletin and the other is an article published by SecurityWeek.

North Korean State-Sponsored Cyber Actors Use Maui Ransomware to Target the Healthcare and Public Health Sector | CISA – This is a joint bulletin from the FBI, CISA, and the US Treasury Department.

Microsoft: North Korean Hackers Target SMBs With H0lyGh0st Ransomware | SecurityWeek.Com

Microsoft this week sounded the alarm on a North Korean threat actor using the H0lyGh0st ransomware in attacks targeting small and midsize businesses worldwide.

If you are a SMB anywhere in the world or you are in the Healthcare and Public Health Sector, pay attention to these alerts.

If you are an SMB in the Healthcare and Public Health Sector of the US, you should definitely consider North Korean cyberattacks a reasonably anticipated threat and evaluate your protections in place based on the details of these announcements.

405(d) Tip of the Week

[15:19] New 405(d) Awareness Product How to Implement Patching.

If you are not sure where to start? We’ve got you covered! We have created three “How-to” resources-one for small, one for medium, and one for large organizations so that you can start protecting your patients from cyber threats right now!

Small Organizations

Medium Organizations

Large Organizations

For more information and resources visit our website at 405d.hhs.gov!

OCR Mic Drops With 11 Patient Right of Access Cases

[20:36] Eleven Enforcement Actions Uphold Patients’ Rights Under HIPAA – July 15, 2022

Yes, all 11 announced at the same time. They weren’t all resolved on the same day but they definitely seem to save them up to make a big splash to get your attention.

Before we get to those 11, let’s cover the single case with a much bigger settlement amount announced the day before these 11 right of access enforcement actions. Oklahoma State University – Center for Health Services Pays $875,000 to Settle Hacking Breach | HHS.gov

Oklahoma State – Center for Health Services Data Breach

OSU-CHS filed a breach report Jan 5, 2018 saying an “unauthorized third party gained access to a web server that contained electronic protected health information (ePHI)”. There was malware installed “on a web server” that resulted in the disclosure of the ePHI of 279,865 individuals, including their names, Medicaid numbers, healthcare provider names, dates of service, dates of birth, addresses, and treatment information.

Wow, $875k for a web server breach you may think to yourself, or not. The reason we are learning about this case is because they had to come back to the well and make an updated deposit on this one. They found out they messed this up over a year before this one and no one did anything about it.

OSU-CHS initially reported that the breach occurred on November 7, 2017, but later reported that the ePHI was first impermissibly disclosed on March 9, 2016. HHS Press Release

At the time of the 2016 incident, OSU-CHS reported that it was not aware that there was electronic PHI stored on that server.

I have to say I worry about this happening a lot. While looking into a current event you learn that over a year ago this same server was hit before. At the time, someone said it was not a big deal – there was no PHI on there. Well… what had happened was… it appears that no one actually looked, ever, if there was PHI on that server.

While the 2018 case seems to have been managed properly, the incident with notifications to HHS and the patients, turns out there is something in the closet that jumps out once someone starts asking questions.

[29:20]
HIPAA covered entities are vulnerable to cyber-attackers if they fail to understand where ePHI is stored in their information systems. Effective cybersecurity starts with an accurate and thorough risk analysis and implementing all of the Security Rule requirements. OCR Director Lisa J. Pino

The OSU resolution agreement includes a “robust” 2-year CAP.

The CAP includes all the normal parts we expect for a security rule case like this one. But, this is the 2nd or 3rd time we have seen monitoring added to the program.

Designation of Independent Monitor. Within 60 days of the Effective Date, OSU-CHS shall designate an individual or entity, to be a monitor and to review OSU-CHS’s compliance with this CAP. The Monitor must certify in writing that it has expertise in compliance with the HIPAA Security Rule and is able to perform the reviews described below in a professionally independent fashion taking into account any other business relationships or other engagements that may exist. Within the above-referenced time period, OSU-CHS shall submit the name and qualifications of the designated individual or entity to HHS for HHS’ approval. Upon receiving such approval, OSU-CHS shall enter into an agreement with the Monitor for the reviews specified below.

The Monitor and OSU-CHS must retain every kind of document created for this program, including draft reports between the two of them, and supply them to HHS for inspection and copying. All must be retained for 6 years.

The monitor reviews must address and analyze the compliance with the CAP. They will also assist in conducting assessments to make sure that they are compliant with the requirements of the CAP. Basically, the monitor will do what we do for our clients on a regular basis. But, and here is the big difference in what we do and what this requires, quarterly reports of the Monitor’s reviews must be submitted to the HHS and OSU-CHS detailing the status of the CAP requirements. And, even bigger deal, any “significant violations of the CAP” must be reported immediately by the Monitor to HHS.

Even tougher, is that OSU can’t terminate any Monitor during the engagement period without submitting notice to HHS and explaining why they intend to terminate the engagement “prior to the termination, unless exigent circumstances require immediate termination”.

If they do terminate any Monitor they must replace them within 30 days of the termination with a Monitor that HHS approves just like in the original engagement. If HHS doesn’t like who you hire you will just need to keep trying until you get someone they approve of before you get in a big mess with HHS.

Oh, and all you folks wanting to be a Monitor, make sure you understand this part:

Validation Review. In the event HHS has reason to believe that: (a) the Monitor reviews or reports fail to conform to the requirements of this CAP; or (b) the Monitor report results are inaccurate, HHS may, at its sole discretion, conduct its own review to determine whether the Monitor reviews or reports complied with the requirements of the CAP and/or are inaccurate (“Validation Review”).

Plus, don’t think that the Monitor reports replace any other reports required in a normal CAP. They do not. These are in addition to the implementation reports that must have an attestation signed by an owner or officer each time they are submitted.

Right of Access Mic Drop

[38:37] All but 1 case is a resolution settlement. One is a CMP. Total amount is $646k for these 11. CAPs all look to be 1 year.

It should not take a federal investigation before a HIPAA covered entity provides patients, or their personal representatives, with access to their medical records,” said OCR Director Lisa J. Pino. “Health care organizations should take note that there are now 38 enforcement actions in our Right of Access Initiative and understand that OCR is serious about upholding the law and peoples’ fundamental right to timely access to their medical records.
Entity Amount Issue
ACPM Podiatry, Peoria, IL $100,000 Patient asked for records beginning in 9/2018 many times to appeal insurance denial. 11/18 was written

12/18 We are “too busy” at year end

1/19 per Dr “Until ins pays bill no recs will be released”

4/8/19 filed complaint, OCR tells ACPM to give the patient the records

4/24/19 “We still have your request and we have your number”

Another complaint filed in May 2019

ACPM ignores OCR finally gives incomplete records to patient July 23, 2020 (618 days)

ACPM has not provided a response yet

Associated Retina Specialists NY, NY $22,500 2/18/2021 complaint. OCR notified them of investigation and 3 days later patient got their records almost 5 months after initial ask
Lawrence Bell, Jr., DDS, Baltimore, MD $5,000 10/15/19 complaint

patient requested records 7/15/19 and had not gotten them. CAP requires them to provide them within 15 days of agreement

Coastal ENT Ormond Beach, FL $20,000 Patient requested records 12/15/20 and 1/8/21

Filed complaints 1/27/21 and 4/20/21

Patient got records 5/20/21

Danbury Psychiatric MA $3,500 Request 3/24/20 records not provided on basis of outstanding balance and required a signed request or authorization request

Complaint file 3/27/20 records provided 9/14/20

Erie County Medical Center Buffalo, NY $50,000 12/26/19 complaint filed. Records provided eventually.
Fallbrook Family Health NE $30,000 Patient made 3 written requests and filed a complaint. Got records 6/19/2020 – FFHC said it was because a workforce member misunderstood the right of access.
Hillcrest Nursing and Rehab MA $55,000 3/22/20 mother requested son’s records

7/13/2020 complaint

10/10/20 records provided

MelroseWakefield MA $55,000 6/12/20 request by personal rep for mother’s records

Denied because durable power of attorney wasn’t enough to provide access

7/20/20 complaint filed

10/20/20 records provided

Memorial Hermann SE TX health system $240,000 6/19 – 1/20 patient made 5 requests for recs

8/31/20 complaint filed

3/26/21 records provided

Southwest Surgical Houston, TX $65,000 12/12/20 complaint filed

2/16/21 OCR notification of investigation

3/5/21 records provided

 
Total right of access cases now up to 38 with a total amount levied one way or another of $2,268,650 with a median amount of $44k per case.

Please make sure this is being done right in your offices!

As usual, you can learn a lot from the CAPs OCR hands down to businesses who’ve had privacy and/or security violations. The newest addition to the CAP is this designation of a monitor to review an entity’s compliance with the OCR CAP. Following a normal CAP is hard enough with all of the documentation and reports you have to file within specific time frames with OCR. It’s not going to get any easier, folks.

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