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Solo Practitioner Agrees to $100,000 Settlement for HIPAA Security Rule Violations

On March 3, 2020, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced a $100,000 settlement and corrective action plan with Steven A. Porter, M.D. to resolve potential...more

2020 Health Care Predictions

The Saul Ewing Arnstein & Lehr, LLP Health Care Practice includes attorneys that handle regulatory, compliance, transactional and litigation needs for clients across the entire health care delivery system, including: ...more

OCR Settles Second Case in HIPAA Right of Access Initiative

On December 11, 2019, the Office for Civil Rights (“OCR”), within the U.S. Department of Health and Human Services , announced a settlement with a covered entity, Korunda Medical, LLC (“Korunda”), to resolve alleged...more

Large Multi-State Hospital System Agrees to Pay $2.175M Settlement for HIPAA Violations

On November 27, 2019, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS), announced a $2.175 million settlement and Corrective Action Plan (CAP) with Sentara Hospitals (Sentara) to...more

Texas State Health Agency Agrees to $1.6 Million Civil Monetary Penalty For Numerous HIPAA Violations

On November 7, 2019, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS) imposed a $1.6 million civil money penalty (CMP) against the Texas Health and Human Services Commission (TX...more

Large New York State Health System Agrees To Pay $3 Million For Its Failure to Repeatedly Encrypt Mobile Devices

On November 5, 2019, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS) announced a $3 million settlement with the University of Rochester Medical Center (URMC) to settle potential...more

Multi-Hospital Florida Academic Medical Center Pays $2.15 Million Civil Money Penalty for Violating HIPAA Security and Breach...

On October 23, 2019, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS) announced that it had imposed a $2,154,000 civil money penalty (CMP) against a Miami-based health system for...more

HHS Publishes Proposed Changes to the Stark Law and Anti-Kickback Statute

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), each issued a proposed rule to amend respectively the...more

Dental Practice Agrees to $10,000 Settlement for Disclosing Patient Health Information on Yelp

On October 2, 2019, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS) announced that it had reached a $10,000 monetary settlement with a Dallas-based dental practice to settle...more

Nationwide Dental Practice Ransomware Incident Underscores Heightened Risk for Medical Providers

More than 400 dental offices across the United States were the victim of a recent ransomware attack that prevented dentists from accessing patient records and patient personal data. ...more

Hospital Agrees to $85,000 Fine for Failure to Provide Timely Access to Patient Records Under HIPAA

On September 9, 2019, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced its first enforcement action and settlement under its Right of Access Initiative. Earlier in 2019,...more

New Comprehensive Report Highlights Impact of Healthcare Data Breaches

IBM Security and the Ponemon Institute recently released their 2019 Cost of Data Breach Report (the “Report”). This is the 14th annual report these groups have published.  ...more

OCR Clarifies Direct Liability of Business Associates Under HIPAA

On May 24, 2019, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), released a new fact sheet describing 10 ways in which a “business associate” can be liable under HIPAA. ...more

Hacked Business Associate Agrees to Pay $100,000 as Part of HIPAA Settlement

On May 23, 2019, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), announced that Medical Informatics Engineering, Inc. (MIE) agreed to pay $100,000 to settle alleged HIPAA violations that...more

CMS Issues DRAFT Guidance for Hospital Co-Location Initiatives; Industry is Invited to Submit Comments

As the health care delivery system continues to evolve, on May 3, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a draft guidance document to state survey agency directors entitled, “Guidance for Hospital...more

“Insecure” Diagnostic Imaging Company Server Leads to $3 Million HIPAA Settlement

On May 6, 2019, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced that Touchstone Medical Imaging (TMI) agreed to pay $3,000,000 to settle alleged HIPAA violations arising out of...more

HHS Lowering Cumulative Annual Civil Money Penalties It Will Apply Under HIPAA and HITECH Acts

On April 26, 2019, the U.S. Department of Health and Human Services (“HHS”) published an Enforcement Discretion letter announcing it is meaningfully lowering the cumulative annual civil money penalties (“CMPs”) it will apply...more

Research Study Highlights How Hospitals May Be Vulnerable to Cybersecurity Threats That Impact Diagnostic Tools

Health care providers are heavily reliant on technology in providing clinical services. The findings from a recent research study highlight the significant threat of cyber risks in health care that is in addition to the...more

FDA Further Outlines Plans to Strengthen and Modernize 510(k) Pathway

Agency continues to promote use of "robust performance criteria" and "modern predicate devices" - On January 22, 2019, the U.S. Food and Drug Administration (FDA or the Agency) detailed in a Final Guidance document the...more

HHS Releases Health Industry Cybersecurity Guidance

On December 28, 2018, the U.S. Department of Health and Human Services ("HHS") released a publication, Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients (the "Cybersecurity Guidance"). ...more

OCR Announces Third HIPAA Settlement in Three Weeks; Issues an RFI on Reducing HIPAA Barriers to Care

There were two important HIPAA developments during this past week. First, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that Pagosa Spring Medical Center (“PSMC”), a Colorado...more

Missing BAA Results in $500,000 HIPAA Settlement

On December 4, 2018, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced that Advanced Care Hospitalists (ACH) agreed to pay $500,000 to settle alleged HIPAA violations arising out of ACH...more

“Expensive News”: Medical Practice Enters Into $125,000 HIPAA Settlement For Sharing PHI With a Reporter

On November 26, 2018, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that Allergy Associates of Hartford, P.C. (AAH) agreed to pay $125,000 to settle alleged HIPAA violations...more

FDA Announces Plans to Significantly Change Medical Device 510(k) Clearance Program

On November 26, 2018, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), issued an extensive...more

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