Archives: Medical Privacy

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Risk Management Strategies to Reduce Risk Associated with Telehealth

The use of technology to provide healthcare has existed for decades; however, recent advances in technology and changes in reimbursement have increased the prevalence of telehealth for diagnosing and treating patients. Telehealth is an emerging and promising method of providing healthcare in areas where healthcare may be limited or unavailable. Telehealth provides quality, cost-effective healthcare … Continue Reading

‘Apparent Inconsistency’ in HITECH Language Leads HHS OCR to Significantly Decrease Yearly Fines

On April 26, 2019, the U.S. Department of Health & Human Services (HHS) issued an announcement that the annual penalty cap for three of the four tiers of HIPAA violations would be reduced significantly to match what HHS called a “better reading” of inconsistent language found in the Health Information Technology for Economic and Clinical … Continue Reading

Deeper Dive: The Landscape of Healthcare Data Breaches

Healthcare was the industry most affected by data breaches in 2018. We worked on nearly 200 healthcare matters involving multispecialty academic medical centers, hospital systems, small and large physician practices, small and large health insurers, and biotech and pharmaceutical companies. In 2018, health information alone was just behind Social Security numbers (which can also be … Continue Reading

Best Cybersecurity Practices for Healthcare Organizations – Insider-Caused Data Loss

This article is part of a series of blog posts exploring the recommendations and guidance Health & Human Services (HHS) provides to healthcare organizations in its Cybersecurity Best Practices report. For previous articles in the series, click here. While any security incident may cause an entity heartburn, when the incident is traced back to an … Continue Reading

Physician Hospitalist Group Settles with OCR and Enters Into a Resolution Agreement for Failure to Have HIPAA Policies and Business Associate Agreement in Place

On Dec. 5, 2018, the Office for Civil Rights (OCR) of the U. S. Department of Health and Human Services (HHS) announced that Advanced Care Hospitalists PL (ACH) had entered into a $500,000 settlement and resolution agreement (RA) resulting from OCR’s investigation of ACH’s breach notification on April 11, 2014, and subsequent supplemental notification. On … Continue Reading

FDA Regional Incident Preparedness and Response Playbook Provides Guidance to the Healthcare Industry for Large-scale, Multi-patient Medical Device Cybersecurity Incidents

Earlier this month, the Mitre Corporation, on behalf of the Food and Drug Administration (FDA), released the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook (the Playbook) as part of the FDA’s ongoing efforts to protect patients from cybersecurity vulnerabilities associated with the use of medical devices. The Playbook highlights high-profile cybersecurity attacks, including … Continue Reading

11th Circuit Issues Opinion Vacating Order That Required LabMD to Overhaul Its Data Security Program

On June 6, the 11th Circuit issued its long-awaited decision on LabMD Inc. v. Federal Trade Commission, vacating as unenforceable the Federal Trade Commission’s (FTC’s) cease and desist order that required LabMD to create and implement a variety of protective measures with respect to data security. Notably, however, the decision did not address the most … Continue Reading

Small Health Care Providers: Do you really know what your IT services vendor is providing to secure your systems?

A small health care provider such as a physician office or clinic often will contract with an IT services vendor to meet overall IT needs to operate the business. A small health care provider may not have the resources and expertise to understand the technical support that an IT services vendor provides, and it relies … Continue Reading

Massachusetts AG Settlement Bars Geofencing Near Medical Facilities

On April 4, 2017, the Massachusetts Attorney General’s office announced that it had settled with a digital advertiser following allegations the company was using geolocation technology to target ads to women visiting reproductive health facilities. Although the company denied that it geofenced clinics in Massachusetts, the AG indicated that such targeting would violate the Massachusetts … Continue Reading

OCR Issues Alert Regarding Phishing Email Disguised as Official OCR Audit Communication

11/30/2016 Update: Today OCR issued another alert relating to the phishing email campaign and has shared that the phishing email originates from the email address OSOCRAudit@hhs-gov.us and directs individuals to a URL at http://www.hhs-gov.us. This is a subtle difference from the official email address for OCR’s HIPAA audit program, OSOCRAudit@hhs.gov. Covered entities and business associates … Continue Reading

A Closer Look at the OCR’s Guidance on Ransomware

In the wake of several high-profile ransomware infections targeting hospitals and health care organizations, the Department of Health and Human Services Office for Civil Rights (OCR) has issued guidance on the growing threat of ransomware. Ransomware is a type of malware that denies access to systems and data. It uses strong cryptography to encrypt files … Continue Reading

OCR to Increase Efforts to Investigate Breaches Affecting Fewer Than 500 Individuals

The Department of Health and Human Services Office for Civil Rights (OCR) is the federal agency tasked with investigating data breaches involving protected health information (PHI) under the Health Insurance Portability and Accountability Act (HIPAA). The mere mention of an OCR investigation can strike fear into the hearts of HIPAA privacy officers and health care … Continue Reading

Unanimous FTC Finds LabMD’s Data Security Practices Violated Section 5 of the FTC Act

On July 29, 2016, a unanimous Federal Trade Commission (“FTC” or “Commission”) issued its Opinion and Final Order reversing the decision of an administrative law judge (“ALJ”) and holding that LabMD engaged in “unfair” practices in violation of Section 5 of the FTC Act because it failed to provide reasonable and appropriate security for personal … Continue Reading

Business Associates in the Crosshairs: Catholic Health Care Services Settles for $650,000 for Failure to Safeguard PHI

Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS) recently agreed to enter into a $650,000 resolution agreement and a two-year corrective action plan (CAP) with the Office for Civil Rights (OCR). CHCS provides management and information technology services as a business associate to six nursing homes. The OCR settlement follows a finding that … Continue Reading

OCR Clarifies “Reasonable, Cost-Based” Fee Calculations for Access to Medical Records

By couching its position in an individual’s right to access protected health information (PHI), beginning on January 7, 2016, the U.S. Department of Health & Human Services’ Office for Civil Rights (OCR) issued guidance to covered entities clarifying access to PHI set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA). §45 … Continue Reading

Deeper Dive: The Changing Landscape of Healthcare Data Breaches

For the second year in a row, the BakerHostetler Data Security Incident Response Report demonstrates that healthcare breaches continue to be the highest percentage of incidents that we handled in 2015. This year’s Report provides insights generated from the review of more than 300 incidents that our attorneys advised on in 2015. The report confirms … Continue Reading

Protecting Patient Data From Hacker Ransom Demands

Forty bitcoins later (approximately $17,000), Hollywood Presbyterian Hospital can now access its electronic medical health records and return to treating its patients as scheduled. But as hackers develop new tools to access information, an increasing number of providers will be targeted and ransom demands will escalate, putting hospitals and patients at risk. Focusing on technical … Continue Reading

SAMHSA Proposes Updates to Substance Abuse Records Security and Confidentiality Regulation

The U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) has released proposed changes to the Confidentiality of Alcohol and Drug Abuse Patient Records regulations (45 C.F.R. Part 2) for the first time since 1987. The proposed changes address challenges that 42 C.F.R. Part 2 programs have faced … Continue Reading

ALJ Upholds OCR’s $239,800 CMP for Healthcare Provider

On January 13, 2016, the Department of Health and Human Services’ Administrative Law Judge upheld the Office for Civil Rights’ (OCR’s) civil monetary penalty (CMP) against Lincare, Inc., d/b/a United Medical (Lincare), for $239,800 in an appeal of OCR’s Health Insurance Portability and Accountability Act (HIPAA) CMPs. Lincare is a home health company that provides … Continue Reading

Another Day, Another OCR Resolution Agreement – Numerous Repeated Breaches Lead to $3.5 Million Settlement

On the heels of the Lahey Hospital and Medical Center resolution agreement, OCR announced a resolution agreement with Triple-S Management Corporation and its subsidiaries, Triple-S Salud Inc. and Triple-C Inc. (collectively “Triple-S”). As part of the announcement, Office for Civil Rights (OCR) Director Jocelyn Samuels flagged two specific areas for covered entities to focus their … Continue Reading

OCR Continues Waving Its HIPAA Enforcement Flag: Don’t Forget About Medical Devices

The day before Thanksgiving, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced the largest resolution agreement of 2015, against Lahey Hospital and Medical Center (Lahey). The incident giving rise to the $850,000 settlement was apparently an isolated theft involving 599 patients with electronic protected health information (ePHI) on … Continue Reading

ALJ Issues Sweeping Decision Dismissing FTC’s Action Against LabMD

On November 13, 2015, the chief administrative law judge (“ALJ”) handling the Federal Trade Commission’s (“FTC” or “Commission”) complaint against LabMD Inc. (“LabMD”) dismissed the case in its entirety. As we previously reported, following two data security incidents involving the disclosure of personal information, the FTC brought an action against LabMD, a clinical testing laboratory, … Continue Reading

Clinically Integrated Networks: Privacy and Security Concerns with Sharing Data

The Centers for Medicare & Medicaid Services (CMS) is changing reimbursement methodologies for healthcare providers from a fee-for-service model to a value-based model. Healthcare providers are responding to the changing environment with the development of clinically integrated networks (CINs) and accountable care organizations (ACOs). The primary purposes of CIN/ACOs are to collaborate with other healthcare … Continue Reading
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