Archives: Health Information Technology

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Smaller HIPAA Breaches To Get More Attention by Office for Civil Rights

The HIPAA breach notification rule has two buckets for classifying data breaches – those that involve “protected health information” (PHI) of 500 or more individuals and those that involve fewer than 500 individuals. Since the breach notification rule became effective, the Office of Civil Rights’ (OCR) focus has been on the 500 and over bucket. But … Continue Reading

HIPAA and $15 Million in 2016

For years, many questioned whether the HIPAA privacy and security rules would be enforced. The agency responsible for enforcement, Health and Human Services’ Office for Civil Rights (OCR), promised it would enforce the rules, but just after a period “soft” enforcement and compliance assistance. That period appears to be ending. During the first seven months … Continue Reading

Check Your Spam Filter, You Might Have Been Selected for a HIPAA Audit!

Yesterday, the federal Office for Civil Rights (OCR) announced Phase 2 of its HIPAA Audit Program (Program). In its announcement, the OCR reports that the Program is underway and provides some helpful FAQs for covered entities and business associates about the Program. Preparation is critical and there are some key points covered entities and business … Continue Reading

HIPAA Covered Entities Not Responsible For Intercepted Transmission of PHI When Individual Requested Unsecured Transmission, Office for Civil Rights Concludes

Earlier this month, the Office for Civil Rights (OCR) issued guidance on an individual’s right to access the individual’s health information. That an individual has a broad right to access has been recognized in the HIPAA privacy regulations since they became effective in 2003. OCR has found, however, that individuals are facing obstacles to accessing their … Continue Reading

FDA Issues Draft Guidance for Connected Medical Devices

Demonstrating a continued focus on information security, the Food and Drug Administration (FDA) published draft guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.  As the title indicates, the draft guidance focuses on issues manufacturers should address in the development and design of medical devices prior to sale to consumers.  This draft guidance … Continue Reading

FDA Issues Draft Cybersecurity Guidance for Device Manufacturers

Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have … Continue Reading

Million Dollar HIPAA Settlements Are About Compliance, Not Harm to Individuals

In the last two weeks, the Office for Civil Rights (OCR) announced two substantial settlements under HIPAA that together totaled $4.35 million. These large amounts seem to be driven not by actual harm to individuals, but in significant part by alleged HIPAA compliance failures identified by OCR following investigations commenced in response to receipt of data … Continue Reading

HIPAA Phase 2 Audits to Start in Early 2016, OCR States In Response to OIG Recommendations

Responding to a Department of Health and Human Services Office of Inspector General (OIG) report recommending stronger oversight of covered entities’ compliance with the HIPAA Privacy Rule, the Office for Civil Rights (OCR) stated that in early 2016 it will launch Phase 2 of its audit program measuring compliance with HIPAA’s privacy, security and breach … Continue Reading

Wearables, Wellness and Privacy

Bloomberg BNA (subscription) recently reported that this fall the Center for Democracy & Technology (CDT) will be issuing a report on Fitbit Inc.’s privacy practices. Avid runners, walkers or those up on the latest gadgets likely know about Fitbit, and its line of wearable fitness devices. Others may know about Fitbit due to the need … Continue Reading

HIPAA Audits Maybe, But Audit Preparedness Definitely!

According to a Bloomberg article, the second phase of HIPAA audits by the Office for Civil Rights (OCR), originally set to commence in 2014, may be coming soon. This update came at a HIPAA conference co-hosted by OCR during which OCR Director Jocelyn Samuels said the agency was in the process of confirming contact information of … Continue Reading

Cancer Care Group to Pay $750,000 to Settle HIPAA Breach, as KPMG Finds 81 Percent of Hospitals and Health Insurance Companies had a Breach in the Past Two Years

On September 2, the Office for Civil Rights (OCR) reported that it agreed to settle potential violations of the HIPAA privacy and security regulations with Cancer Care Group, Inc. The dollar amount of the settlement, $750,000, is significant, and the agreement to adopt a robust, multi-year corrective action plan under the watchful eye of the … Continue Reading

The Hololens From Microsoft – Help Can Be Right Under…Over Your Nose

The saying – never let them see you sweat – soon may be more difficult to accomplish with Microsoft’s Hololens. Like Google Glass, the Hololens is worn as a headset. But this device has a “plurality” of sensors that gather a range of biometrics parameters (heart rate, perspiration, etc.) which determine along with other information … Continue Reading

Connecticut State Contractors, Health Insurance Industry Businesses Subject to Enhanced Significant Data Security Mandates

In June, Connecticut’s governor signed into law Senate Bill 949 which amended the State’s breach notification statute. The requirement that covered businesses must provide one year of identity theft protection services for certain breaches, easily the most popular aspect of the legislation, may have diverted attention from some significant aspects of this new law. Senate Bill … Continue Reading

EEOC Wellness Program Regulations Offer Best Practices for Medical Record Confidentiality

As reported on our Benefits Law Advisor, the EEOC has issued proposed wellness program regulations. Much of the attention to those proposed rules understandably will be how they would affect the incentives employers have implemented to spur their employees to engage in healthier behaviors. The proposed rules also address, however, the confidentiality provisions under the Americans with Disabilities Act … Continue Reading

ACA Information Reporting Creates Data Privacy and Security Issues

During this year, businesses will be hearing a lot about the Affordable Care Act’s (ACA’s) information reporting requirements under Code Sections 6055 and 6056. Information gathering will be critical to successful reporting, and there is one aspect of that information gathering which employers might want to take action on sooner rather than later – collecting Social Security … Continue Reading

Employer FAQs: Responding to the Anthem Breach

The first massive data breach of 2015 hit one of the country’s largest insurance issuers, Anthem, Inc., including Anthem Blue Cross and Blue Shield and other related entities (Anthem). The incident reportedly affected over 80 million persons who are or were covered under a policy or program insured or serviced by Anthem. The personal note … Continue Reading

FTC Announces “Concrete Steps” for IoT Privacy and Security

As the vast array of internet-connected devices mushrooms, and technologies permit those devices to communicate with one another, calls for privacy and security can be heard. On the heels of a recent victory in the ongoing LabMD case, the Federal Trade Commission (FTC) announced yesterday “concrete steps” businesses can take to enhance the privacy and … Continue Reading

Healthcare Providers and Business Associates: Don’t Ignore the Insider Threats

News reports of security risks, hackings and breaches caused by individuals, terror groups or even countries around the world certainly are important and can be unsettling. But, for many organizations, including healthcare providers and business associates, a significant and perhaps more immediate area of data risk rests with an organization’s workforce members. An organization’s information … Continue Reading

President Obama to Call For National Data Breach Notification Law and Other Cybersecurity Measures

About two years ago, President Obama signed an executive order on the date that he delivered his State of the Union address which directed certain federal agencies to develop voluntary standards for achieving cybersecurity. Preparing for his 2015 State of the Union address, Bloomberg and other news outlets are reporting this morning that President Obama will … Continue Reading

Data Security in 2015 for Banks, HIPAA Covered Entities, and Small Businesses Too

Some have called 2014 the “Year of the Data Breach.” That may be true given the steady stream of large-scale data breaches affecting tens of millions of individuals. We do not know if this time next year commentators will be saying the same thing about 2015, but there are signs pointing to a significant tightening … Continue Reading

OCR Issues Ebola Guidance on HIPAA Privacy

According to the New York Times, Bellevue Hospital Center patient Craig Spencer, the first New Yorker to be infected with Ebola, is scheduled to be released today. And while the intense reporting about Ebola has subsided, perhaps indicating a lowering of the perceived threat of Ebola spreading further in the U.S. (although many continue to … Continue Reading

Liability for Providing Too Little Information?

Most employers are well aware that potential liability lurks if unauthorized information is disclosed to third parties. Obvious examples would include unauthorized employee or applicant health or financial information or personal information such as social security numbers and the like. In an interesting twist, the Minnesota Supreme Court considered whether liability could be created when … Continue Reading

Re-Emphasis on Third-Party Service Provider Security In Financial Services…A Reminder for All Businesses

A New York Times article earlier this week reported that top officials at the Treasury Department have identified a key area for strengthening data security – third-party service providers. Reuters reported that on Tuesday of this week New York State Department of Financial Services superintendent, Benjamin Lawsky, sent a letter to a number of banks inquiring … Continue Reading

Data Breach Notification Deadline Extended 10 Days for Certain Healthcare Providers in California

While recent legislation has tended to tighten data breach notification requirements (e.g., Florida and California), Assembly Bill 1755 extended the breach notification deadline from five to 15 days for certain healthcare providers. More specifically, according to AB1755 which becomes effective January 1, 2015, the deadline to provide notification of a breach of medical information for healthcare providers covered by … Continue Reading
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