OCR HIPAA Enforcement Relatively Lite

Andrea Fox of HealthcareNewsIT (https://www.healthcareitnews.com/) reported on November 27, 2024, that OCR HIPAA enforcement is relatively lite.  When OCR (Office of Civil Rights) had identified serious compliance issues including discovery of security flaws, followup was rare according to the HHS inspector general’s (OIG) audit program review. The OIG review reviewed records from January 2016 through December 2020.  The Office of Civil Rights could have initiated follow-up after discovering security flaws, but “rarely initiated these reviews when it identified serious compliance issues,” according to the HHS inspector general’s audit program review.

“While OCR fulfilled its requirement under the HITECH Act to perform periodic HIPAA audits, OCR oversight of its HIPAA audits program likely was not effective at improving cybersecurity protections at entities,” OIG said in its findings. … “However, assessing two administrative security requirements is generally not sufficient to assess the risk within the healthcare sector and to determine the effectiveness of the [electronic protected health information] security protections that should be in place, as required by the [HIPAA] Security Rule,” OIG said.

After evaluating OCR’s program for performing periodic HIPAA audits, OIG recommended expanding the scope to better execute on HITECH Act of 2009 requirements, which extended criminal and civil penalties to business associates of covered entities.

Read the article at this link:

https://www.healthcareitnews.com/news/ocrs-hipaa-audit-program-lacked-mettle-oig-says

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

SoftwareCPR Training Courses:

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

Register Now


 

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.