Nicole Martin

Nicole Martin

Cozen O'Connor

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Latest Publications


FTC Loses in LabMD Data Security Case: ALJ Sets High Bar for Consumer Harm

On November 13, 2015, an administrative law judge (“ALJ”) ruled against the Federal Trade Commission (“FTC”) in its high-profile data security case against LabMD. The ALJ ruled that the FTC had failed to show that LabMD’s...more

11/25/2015 - Actual Injuries ALJ Data Security FTC LabMD Section 5

ALJ Rules Against FTC in LabMD Data Security Action: Sets High Bar for Proving Consumer Harm

Last June we wrote about the FTC’s enforcement action against LabMD, a medical testing laboratory, which was forced to wind down its business because of the costs associated with challenging the FTC since 2013. Using its...more

11/23/2015 - Actual Injuries ALJ Data Security FTC FTC Act LabMD Section 5 Unfair or Deceptive Trade Practices

Executives in the Crosshairs: DOJ Increases the Focus on Individuals to Combat Corporate Wrongdoing

Earlier this month, the Deputy Attorney General of the Department of Justice (“DOJ”) released a memorandum (“Guidance”) setting forth six key steps to which DOJ attorneys should adhere in the investigation of corporate...more

9/23/2015 - C-Suite Executives Corporate Misconduct DOJ Government Investigations New Guidance Personal Liability

The Time is Right for Hospitals to Ensure 501(r) Compliance

Updated requirements for hospitals to maintain their tax-exempt status under Section 501(r) of the Internal Revenue Code are nothing new. They were enacted as part of the Affordable Care Act in 2010. However, at the end of...more

9/15/2015 - Affordable Care Act Enforcement Final Rules Healthcare Hospitals Internal Revenue Code (IRC) Section 501r Tax Exempt Entities

Physician Group to Pay $750,000 to Settle a HIPAA Violation

In August 2012, a Physician Group—comprising of nearly 20 physicians—reported its HIPAA breach to HHS, which resulted from a laptop bag containing the employee’s laptop and a computer server backup being stolen from an...more

9/4/2015 - Data Breach HHS HIPAA PHI Physicians Settlement

Revamped Telehealth Bill Referred to the House and Energy Commerce Committee and the House Committee on Ways and Means

On July 7, 2015, U.S. Reps. Mike Thompson, Gregg Harper, Diane Black, and Peter Welch announced the introduction of a new version of the July 2014 telehealth legislation (H.R. 5380) called the Medicare Telehealth Parity Act...more

7/10/2015 - Legislative Committees Medical Reimbursement Medicare Proposed Legislation Telehealth Telemedicine

Senate Approves Medicare “Doc Fix” Legislation

We wrote in late March about the U.S. House of Representatives passing SGR legislation intended to be a permanent cure to Medicare’s “doc fix” legislation. ...more

4/16/2015 - Healthcare Medicare New Legislation Physician SGR Formula Physicians

On the Horizon … A Possible “Permanent” Cure to Medicare’s “Doc Fix”

In a historic bipartisan moment, the U.S. House of Representatives passed a nearly 300-page bill that is intended to “repeal the Medicare sustainable growth rate [“SGR”] and strengthen Medicare access by improving physician...more

3/30/2015 - Healthcare Medicare Pending Legislation Physician SGR Formula Physicians

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

3/13/2015 - Clinical Trials Electronically Stored Information FDA Healthcare Informed Consent Prescription Drugs

Pennsylvania Federal Court Reiterates EMTALA’s Inapplicability to Transfers of “Admitted Patients”

On February 23, 2015, the District Court in Baney v. Fick held that a patient’s complications arising from elective surgery do not fall under the purview of the Emergency Medical Treatment and Labor Act, 42 U.S.C. § 1395dd,...more

3/4/2015 - Healthcare Surgery

Time to Get Rid of Those Post-it Notes with All Your Passwords!!!

This month, Governor Chris Christie signed into law a New Jersey bill requiring health insurance carriers (e.g., insurance companies, health service corporations, hospital service corporations, medical service corporations,...more

1/23/2015 - Encryption Health Insurance HIPAA New Legislation Personally Identifiable Information

CMS Releases Final Rule That Increases Difficulty of Medicare Enrollment

In early December, CMS released a final rule that implements certain provider (i.e., Hospitals, SNFs, physicians, etc.) and supplier (i.e., DME companies, etc.) enrollment requirements (“Rule”). The goal of CMS’...more

12/17/2014 - CMS Enrollment HHS Hospitals Medical Devices Medicare OIG Physicians SNF

OIG Releases Proposed Gainsharing Regulation

In early October, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released a proposed rule that included, among other provisions, a proposed gainsharing regulation (“Proposed Rule”),...more

12/16/2014 - Affordable Care Act Gainsharing HHS Hospitals OIG Physicians

OCR Publishes Bulletin Regarding Privacy in Light of Ebola Outbreak

In response to the recent Ebola outbreak in West Africa and in light of patients being treated in several hospitals in the U.S., the HHS, OCR (OCR) recently issued a HIPAA Bulletin to remind us that HIPAA covered entities and...more

11/19/2014 - Business Associates Covered Entities Ebola HIPAA OCR PHI

CDC Publishes Updated Interim Guidance Regarding Potential Ebola Exposure

According to the World Health Organization, the Ebola outbreak is “the biggest and most complex . . . in history,” and in August, the World Health Organization declared the Ebola outbreak in West Africa to be a “Public Health...more

10/29/2014 - CDC Ebola World Health Organization

CDC Publishes Revised Ebola Guidelines and Announces New Monitoring Program

The CDC recently announced stricter guidelines on the use of personal protective equipment for United States healthcare workers providing healthcare services to patients with Ebola (“Guidelines”). According to the CDC, the...more

10/24/2014 - CDC Ebola Employer Liability Issues Health Care Providers Hospitals Physicians Workplace Safety

Skilled Nursing Facility Reaches Largest Failure of Care Settlement in DOJ History

On Friday October 10, 2014, the Department of Justice (DOJ) and the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) jointly announced a $38 million settlement with a skilled nursing facility...more

10/14/2014 - DOJ Health Care Providers Healthcare HHS Nurses OIG Settlement Skilled Nursing Facility

CMS Approves Pennsylvania’s Medical Assistance (Medicaid) Waiver

CMS approved Pennsylvania’s Medical Assistance (“Medicaid”) waiver request entitled Healthy Pennsylvania (“Waiver” or “Healthy Pennsylvania”) by letter dated August 28, 2014. Governor Tom Corbett and the Pennsylvania...more

9/9/2014 - Affordable Care Act CMS Health Insurance Healthcare Medicaid Waivers

Special (Limited) CMS Offer to Settle Claims on Appeal

With little fanfare just before the Labor Day weekend, CMS announced a program in which it would enter into administrative agreements with eligible providers in exchange for the providers’ withdrawal of pending appeals...more

9/4/2014 - Appeals CMS Healthcare Hospitals Recovery Audit Contractors (RACs) Settlement

Recent OCR Reports Illustrate Past and Future Compliance and Enforcement Efforts

Daily news stories about data breaches and enforcement actions seem to be the new norm, so it’s no surprise that people may start to believe that hackers have won the war and that no personal health information is safe. But...more

7/30/2014 - Compliance Data Breach Data Protection Enforcement Enforcement Actions OCR

We Don’t Need No Intervention: Qui Tam Relator in Omnicare Wins Big Without DOJ

The United States Department of Justice (DOJ) recently announced the settlement of two qui tam whistleblower lawsuits against Omnicare Inc., the largest nursing home pharmaceutical and pharmacy services vendor in the nation....more

7/24/2014 - DOJ Nursing Homes Omnicare Qui Tam Whistleblowers

The American Medical Association Releases New Telemedicine Recommendations

Recently, the American Medical Association (AMA) released a report on telemedicine (Report) that, among other things, (i) outlines coverage and payment rules; (ii) summarizes various specialty society practice...more

7/10/2014 - American Medical Association Healthcare Telemedicine

Begin Preparing for Pennsylvania’s Enforcement of Act 122

The Pennsylvania Department of Health (“DOH”) Bureau of Laboratories (“Bureau”) recently announced that it will begin to phase-in enforcement of Act 122, which amended the Pennsylvania Clinical Laboratory Act (“Lab Act”),...more

7/3/2014 - Clinical Laboratories Healthcare Healthcare Facilities Physicians

Enforcement Action – FTC Is Not Backing Down and Laboratory Company Goes After a Cyber-Intelligence Company

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is not the only government arm that enforces data breaches. The Federal Trade Commission (FTC) has broad authority to regulate the security of...more

6/11/2014 - Cybersecurity Data Protection Enforcement Enforcement Actions FTC HHS Popular

Data Brokers: “Off the Radar” – FTC Calls for Greater Oversight

A report recently released by the Federal Trade Commission (FTC) concludes that data brokers currently operate so far below the radar screen that most consumers are unable to exercise any real control over the collection and...more

6/10/2014 - Data Brokers Data Collection FTC Transparency

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