FDA recently released guidance (“Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request”) finalizing its policy on medical device manufacturers sharing patient-specific information from devices with patients at the patients’ request. In response to the more active roles patients are playing in their health care, and increased frequency with which patients are seeking … Continue Reading
The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “12 Months in Health Care Law: A Roller Coaster Journey” on October 25, 2016 at 12:00 p.m. ET. Please join Reed Smith Partner Elizabeth Carder-Thompson as she presents her annual informative and entertaining review of many of the key regulatory … Continue Reading
Following a recent U.S. government interagency report indicating that, on average, there has been an alarming 300 percent spike in daily ransomware attacks since early 2016 as compared with 2015, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released new Health Insurance Portability and Accountability Act (“HIPAA”) guidance on … Continue Reading
Two separate instances of unencrypted laptop theft from different health care providers have resulted in two settlements for potential violations of the HIPAA Privacy and Security Rules. These alleged violations were uncovered following investigations by the Department of Health and Human Services, Office for Civil Rights (OCR). In the first instance, involving Concentra Health Services, OCR found that Concentra had previously recognized its need for increased encryption on its technological devices but had failed to fully address this issue before the breach. In the second instance, involving QCA Health Plan, Inc. of Arkansas, OCR found that QCA had failed to comply with multiple requirements set forth by the HIPAA Security Rule. Both instances resulted in settlements comprised of financial payments to OCR as well as agreement to Corrective Action Plans that will allow for continued oversight by OCR in regards to HIPAA compliance.… Continue Reading
On February 6, 2014, the U.S. Department of Health & Human Services' (HHS) Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, and Office for Civil Rights jointly published a final rule amending the HIPAA Privacy Rule and the Clinical Laboratory Improvement Amendments of 1988 regulations to provide patients with direct access to laboratory test reports. HHS believes that patients should have the right to access these test reports in order to gain vital information, allowing them to better manage their health and take action to prevent and control disease. The amendments to both regulations become effective April 7, 2014, and HIPAA-covered laboratories must comply by October 6, 2014.… Continue Reading
The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) have each proposed new rules to extend existing protections that allow hospitals to donate electronic health record (EHR) technology to physicians who refer patients to their facilities. By way of background, in 2006, CMS established an exception to the Stark self-referral law to allow hospitals to donate EHR technology to physicians under certain circumstances. Likewise, in 2006, the OIG established a safe-harbor to protect such EHR donations from enforcement under the federal anti-kickback statute. While both protections are set to expire on December 31, 2013, the proposed rules would extend the provisions until the end of 2016 as a means to facilitate the adoption of EHR technology.… Continue Reading
On September 17, 2012, the HHS Office of Civil Rights ("OCR") announced another settlement and corrective action plan following an entity's breach self-report required by HITECH's Breach Notification Rule. Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates, Inc. (collectively "MEEI") have agreed to pay $1.5 million to settle potential violations of the HIPAA Security Rule following the theft of a physician's unencrypted, but protected, laptop, providing additional evidence that: (1) OCR will likely view any breach notification as an opportunity to conduct a de facto audit of an entity's general HIPAA compliance; and (2) encryption of all portable devices containing electronic protected health information ("ePHI"), though not technically "required," is a critical compliance consideration.… Continue Reading
On April 17, 2012, the HHS Office of Civil Rights (OCR) announced a settlement and corrective action plan with Phoenix Cardiac Surgery, P.C. (Phoenix), a small cardiology practice based in Phoenix and Prescott, Arizona. More specifically, Phoenix has agreed to pay $100,000 to settle allegations of HIPAA violations arising out of an investigation conducted by OCR.… Continue Reading
On March 13, 2012, the HHS Office of Civil Rights (OCR) announced the first enforcement action resulting from a breach self-report required by HITECH's Breach Notification Rule. Blue Cross Blue Shield of Tennessee (BCBST) has agreed to pay HHS $1,500,000 to settle potential violations of the HIPAA Privacy and Security Rules and has entered into a corrective action plan to address gaps in its HIPAA compliance program.
The HIPAA/HITECH Breach Notification Rule requires covered entities to report a breach (e.g., an impermissible use or disclosure of protected health information that compromises the security or privacy of the protected health information) to the affected individual(s), HHS and, at times, the media. OCR's investigation of BCBST followed a breach report submitted by BCBST informing HHS that 57 unencrypted computer hard drives were stolen from a leased facility in Tennessee. The hard drives contained the protected health information of more than 1 million individuals, including member names, social security numbers, diagnosis code, dates of birth, and health plan identification numbers.
According to OCR's investigation, BCBST failed to implement appropriate administrative and physical safeguards as required by the HIPAA Security Rule. More specifically, BCBST failed to perform the required security evaluation in response to operational changes and did not have adequate facility access controls.
In addition to the $1,500,000 settlement, the Resolution Agreement between BCBST and OCR requires BCBST to revise its Privacy and Security policies, conduct robust trainings for all employees, and perform monitor reviews to ensure compliance with the corrective action plan. BCBST did not admit any liability in the agreement and OCR did not concede that BCBST was not liable for civil monetary penalties.
Additional information about OCR's enforcement activities can be found at http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/index.html.… Continue Reading
The interest level in storing health records in digital format has grown rapidly with the lower cost and greater availability and reliability of interoperable storage mechanisms and devices. Health care providers like hospitals and health systems, physician practices, and health insurance companies are among those most likely to be considering a cloud-based solution for the storage of patient-related health information. While lower cost, ubiquitous 24/7 availability, and reliability are key drivers pushing health care providers and insurers to the cloud, a number of serious legal and regulatory issues should be considered before releasing sensitive patient data into the cloud. The issues are highlighted in the Health Care chapter of our Cloud Computing White Paper.… Continue Reading
On May 16, 2011, the Office of Inspector General ("OIG") published a report with the results from its nationwide review of the Centers for Medicare and Medicaid Services ("CMS'") oversight of the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"). In its review, the OIG sought to determine the sufficiency of CMS' oversight and enforcement actions pertaining to hospitals' implementation of the HIPAA Security Rule. Pursuant to the Security Rule, covered entities, such as hospitals, must implement technical, physical, and administrative safeguards for the protection of electronic protected health information ("ePHI"). According to the OIG, CMS' oversight and enforcement actions were "not sufficient," leaving limited assurance of the security of hospitals' ePHI.
The report details the results from the OIG's audits of seven hospitals. The audits disclosed "numerous internal control weaknesses." Specifically, the OIG identified 151 vulnerabilities in the systems and controls intended to protect ePHI. Of these vulnerabilities, 124 were categorized as "high impact." These vulnerabilities placed the confidentiality, integrity, and availability of ePHI at risk. The consequences of the high impact vulnerabilities is that it (1) may result in the highly costly loss of major tangible assets or resources; (2) may significantly violate, harm, or impede an organization's mission, reputation, or interest; or (3) may result in human death or serious injury.… Continue Reading
This post was written by Gina M. Cavalier. Earlier today the Department of Health and Human Services’ (HHS), Office for Civil Rights (OCR) announced the imposition of the first ever civil money penalty for violations of the HIPAA Privacy Rule. The penalty – which is $4.3 million – was assessed against Cignet Health of Prince … Continue Reading
Information security is paramount in the life sciences and health care industry because it is subject to affirmative regulatory requirements regarding the physical and technical safeguards used to secure electronic information. It is therefore troubling that the Internet protocols that are universally used to transmit encrypted information employ an authentication process (to verify the endpoints of a communication) that is deeply flawed. The authentication process requires the parties to the communication to trust literally hundreds of unknown third parties referred to as "certificate authorities." The closer one looks at the identity of these third parties and the processes used to carry out the authentication process, the worse it gets. It is time for GCs to get involved because Encryption is Not Enough...… Continue Reading
The Health Information Privacy page of the U.S. Department of Health and Human Services (HHS) website has formally announced that regulations implementing the privacy and security provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act will soon be published (along with a comment period) relating to (1) business associate liability; (2) new limitations on the sale of protected health information, marketing and fundraising communications; and (3) stronger individual rights to access electronic medical records and restrict the disclosure of certain information. Although this posting is certainly welcome news, from a timing perspective the announcement only indicates that "OCR continues work on a Notice of Proposed Rulemaking (NPRM) regarding these provisions."… Continue Reading
The Federal Communications Commission ("FCC") has proposed changes to its Telephone Consumer Protection Act ("TCPA") rules that would conform to the Federal Trade Commission's Telemarketing Sales Rule ("TSR"). The primary change in the regulations would affect the sending of prerecorded messages (a/k/a "robocalls") by barring them even to existing customers without first obtaining prior written consent. At first blush, this seems routine, but because of differences in the FCC's and FTC's statutory jurisdiction, there are complicated implementation issues that could trap unsuspecting companies. Other key issues for the health care industry is whether the FCC should create an exemption for prerecorded messages that are subject to Health Insurance Portability and Accountability Act ("HIPAA") and, if so, how such exemption should be implemented. For more information about these changes, please read our client alert written by Robert Jackson.… Continue Reading
On Friday, October 30, 2009, the U.S. Department of Health and Human Services ("HHS") published an interim final rule and request for comments that implements certain HIPAA enforcement changes made pursuant to the HITECH Act. Consistent with the provisions of the HITECH Act, the new rule amends the HIPAA enforcement regulations applicable to violations of each of HIPAA's Administrative Simplification Rules (i.e., Privacy Rule, Security Rule, Transactions and Code Sets Rules, Standard Unique Identifier for Employers (EIN Rule), and the Standard Unique identifier for Health Care Providers (NPI Rule)) by instituting the below categories of violations and tiered penalty scheme to HIPAA violations that occur on or after February 18, 2009.… Continue Reading
The recently enacted Health Information Technology for Economic and Clinical Health ("HITECH") Act, which amends various aspects of the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), including the associated Privacy and Security Rules, marks a significant change in how covered entities and their business associates must respond to security breaches under HIPAA.… Continue Reading
Until now, the loss or theft of protected health information rarely resulted in notice to consumers. Very few state data security breach notification laws encompass medical information. The Health Insurance Portability and Accountability Act ("HIPAA") merely required an "accounting" of such events to a patient upon the patient's request.
All that has changed. Congress, in enacting the Health Information Technology for Economic and Clinical Health Act ("HITECH"), imposed breach notification obligations on many of the individuals and business entities that receive, create, or maintain patients' individually identifiable health information. Pursuant to HITECH, on Aug. 17, the Federal Trade Commission ("FTC") issued its Health Breach Notification Rule, governing the breach notification obligations of three new categories of entity: "vendors of personal health records," "PHR related entities" and "third party service providers."… Continue Reading
On February 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the "ARRA"). The sweeping $790 billion economic stimulus package includes a number of health care policy provisions. Reed Smith's Health Care Memorandum summarizes the major health policy provisions of the Act.… Continue Reading
On Feb. 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the "ARRA").1 This memorandum outlines significant changes and additions to the landscape of federal privacy and security law set forth in Subtitle D of the ARRA. In general, the privacy and security portions of the ARRA become effective 12 months after the enactment of the ARRA, which is approximately February 2010. It is also important to note that the ARRA directs the Secretary of the U.S. Department of Health & Human Services ("HHS") to amend the HIPAA Privacy and Security Rules to implement the legislative changes. As such, the effective dates associated with the rulemaking process will vary.… Continue Reading
In “Ex Parte Talks Allowed Under Georgia Law For Counsel, Doctors Preempted by HIPAA” (password required), the United States Law Week discusses in detail Moreland v. Austin, Georgia Sup. Ct. No. S08G0498, a November 3, 2008 decision holding that defense attorneys who wish to engage in ex parte communications with plaintiffs’ treating physicians must comply … Continue Reading
Data breaches can occur in any industry, but those that involve medical information create unique problems. Starting January 1, they also will carry unique penalties, at least in California. The new California laws, Senate Bill 541 (SB 541) and Assembly Bill 211 (AB 211). Health care providers clearly need to take heed of the laws’ … Continue Reading
This post was written by Catherine A. Durkin and Areta L. Kupchyk. On May 22, 2008, the Food and Drug Administration (“FDA”) announced plans for what it is calling the “Sentinel System”—a new, national electronic health information surveillance system to track the performance and safety of medical products once they are on the market. In … Continue Reading