March 2021 Bulletin: HIPAA Safe Harbor For Cybersecurity Act- HR7898 – HHS Incentives For Cybersecurity Efforts By Your Practice
March 25, 2021
Dear OMIC Insureds:
In the last 2 months alone, cyberattacks against healthcare entities increased 45 percent. For example, in 2020 there were 642 cybersecurity breaches, involving 500 or more records, compared to 519 breaches in 2019, and 368 breaches in 2018.
As a positive incentive for healthcare providers to increase investment in cybersecurity for the benefit of regulatory compliance, and, ultimately, patient safety, the HIPAA Safe Harbor for Cybersecurity Act was signed into law in January, 2021. The HIPAA Safe Harbor bill amends the HITECH ACT, requiring the Department of Health and Human Services to provide incentives for best-practice cybersecurity measures to meet HIPAA requirements. The Senate unanimously passed the legislation without amendment on December 19, 2020.
This legislation directs HHS to consider a covered entity’s or business associate’s use of industry-standard security practices within the previous 12 months when investigating and undertaking HIPAA enforcement actions, or for other regulatory purposes. The legislation directs HHS to consider:
- easing of fines related to security incidents, and
- early, favorable termination of an audit, if it’s determined the impacted entity has indeed met industry-standard best practice security requirements.
- Of note, these changes to the HITECH Act do not give HHS the authority to increase fines or the extent of an audit when an entity is found to be out of compliance with the recognized security standards.
To comply with the new bill, “recognized security practices” need to be instituted by your practice for not less than 12 months prior to a HHS investigation or HIPAA enforcement action or other regulatory purposes. We recommend you begin implementing these protocols now so your practice will qualify for these safe harbor considerations.
Use these resources for specific guidance on standards, best practices, methodologies, procedures, and processes:
- The National Institute of Standards and Technology Act (NIST Act) NIST-cyberframework
- The Cybersecurity Act of 2015 Cybersecurity Act- Health Industry Cybersecurity Practices HICP
- Other statutory authorities that require specific programs and processes, such as state requirements. state data breach notification laws
- Practices determined by the covered entity or business associate, consistent with the HIPAA Security rule
In addition, HHS provides safe harbor under the Anti-kickback safe harbor statute. This final rule amends the safe harbors to the Federal anti-kickback statute by adding new safe harbors and modifying existing safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute.
View a risk management presentation on this topic on our website (OMIC /CyberNET page)
Sail Into the New HIPAA Safe Harbor
If you have questions, contact us for confidential risk management advice at riskmanagement@omic.com. Or call us at 1-800-562-6642, enter 4 for Risk Management.
Sincerely,
Hans K. Bruhn, MHS, OMIC Risk Manager
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Yag Capsulotomy
Version 03/5/2021
INFORMED CONSENT FOR YAG LASER CAPSULOTOMY AFTER CATARACT SURGERY
What is Yag laser capsulotomy?
Yag capsulotomy is a laser treatment used to improve vision after cataract surgery, and is usually performed as an outpatient.
A common occurrence after cataract surgery is clouding of the part of the natural lens covering (the capsule) that remains after surgery. This membrane may become cloudy and cause blurred vision, and sometimes patients will see streaks or haloes around lights. This can occur several months or even years after surgery. This problem can worsen with time.
YAG laser treatment can be done without anesthetic or ocular incision. The laser is applied to the clouded posterior capsule and creates a small opening that allows light to pass though and create clearer vision. After the laser treatment, there is no interruption in physical activities and no patch is needed.
Benefits
Yag capsulotomy is performed to open the clouded part of the membrane and improve vision.
Risks
The most common complication of Yag laser capsulotomy is short-term increased pressure inside the eye, which may require drops to lower the pressure. Additionally, some patients may develop new floaters after this procedure.
Less common risks include:
- • Detachment of the nerve layer at the back of the eye (retinal detachment)
- • Swelling of the center of the retina (macular edema)
- • Damage to or displacement of the intraocular lens
- • Migration of vitreous gel to position in front of intraocular lens
Alternatives
The alternative is to do nothing. The membrane may continue to thicken over time and cause a worsening of your vision. You may elect to have the Yag capsulotomy at a later date.
Patient Statement:
- • I have read this informed consent form, or someone has read it to me.
- • I understand the information in this informed consent form.
- • I have been informed about the possible benefits, complications, risks, and alternatives to Yag capsulotomy.
- • I have been given the opportunity to ask questions and received satisfactory answers.
- • I understand that no guarantee of a particular outcome was given.
- • By signing below I am making an informed decision to undergo Yag laser capsulotomy. I received (or have been offered) a copy of this consent.
I HEREBY GIVE MY INFORMED CONSENT FOR DR. ____________________
TO PERFORM YAG LASER CAPSULOTOMY IN MY _____________ EYE. (state right or left)
_______________________________________
Signature of patient (or person authorized to sign for patient)
_______________
Date
_______________________________________
Printed name
