Tag:

compliance

Rush University Medical Center’s 2019 Privacy Breach Incident

In March 2019, Rush University Medical Center (“Rush University”) sent out breach notification letters to approximately 45,000 patients. The letter advises patients that a privacy incident occurred that may have involved the patients’ personal information. The privacy incident was caused by an employee of a third-party financial services vendor. The employee released a file that contained patient information to an unauthorized person. According to the breach notification letter, law enforcement and regulatory officials were involved in the investigation of the privacy incident. Rush University sent the breach notification letter in compliance with the Health Insurance Portability and Accountability Act’s privacy and security rules.

A US Data Privacy Law That Bites, Hopefully

Despite industry groups’ and tech companies’ numerous efforts over the past few months to water down and ultimately halt the first-ever U.S. data privacy law, the California Consumer Privacy Act of 2018 (“CCPA” or “the Act”), the CCPA now has its final language set on September 13, 2019, the end of California’s legislative calendar, and will go into effect on January 1, 2020. The goal is to give California residents control of their personal information collected and processed by companies.

HIPAA Simplification Compliance Review Now Underway

The Health Insurance Portability and Accountability Act (HIPAA) and the Patient Protection and Affordable Care Act (ACA) jointly create national standards for electronic transactions, code sets, and unique identifiers. The ACA introduced Administrative Simplification provisions in 2010 and now the Centers for Medicaid and Medicare Services (CMS) has launched a Compliance Review Program to ensure that HIPAA covered entities are abiding by the Administrative Simplification rules.

Regulating Artificial Intelligence – Is It Possible?

Artificial intelligence is all around us. Whether it exists in your iPhone as “Siri” or in complex machines that are detecting diabetic retinopathy, it is constantly growing and becoming a regular part of the modern day. As with any new technology, regulation surrounding artificial intelligence is becoming increasingly problematic. The question facing us now is how do we encourage further development without accidentally hindering its growth? Recently, the Food and Drug Administration has attempted to take steps toward further regulation of artificial intelligence by introducing a review process for medical artificial intelligence. This is just one instance of how regulation may affect the evolution of artificial intelligence.

Cook County, Illinois Revised HIPAA Qualified Protective Order Signals New Responsibility for Injury Attorneys

Cook County General Administrative Order 18-1 pertains to the Standard HIPAA Qualified Protective Orders (QPO) that will be permitted in Cook County. These orders will only be allowed for cases that are in litigation where the Plaintiff and Plaintiff’s counsel authorize disclosure of a litigants’ protected health information (PHI). It also requires all entities who received PHI to either return the documents to the Plaintiff or destroy them at the end of the case. These changes mean that Plaintiff’s attorneys will see a change in the handling of Plaintiff’s medical records and other documents covered under the QPO containing PHI.

We Need to Change the Way We Deal with Food Recalls

In September 2018, the Food and Drug Administration (“FDA”) announced a new policy that provides for the release of a list of retailers that have received a food subject to recall. In the past, the FDA did not release such information because the agency deemed it confidential commercial information. The lack of information on the part of the FDA has been a huge detriment to the public. Prior to the new guidance, the public would only find out information about the particular food that was being recalled, not where this recalled food was available for purchase. The public was told just to stop purchasing that recalled food, whether it be romaine lettuce or beef, even if there were retailers who were selling non-contaminated products. This procedure not only hurts the public but also has a huge financial effect on those retailers who are not selling contaminated or recalled products. The FDA has effectuated a new guidance because they have found that such information is necessary to enforce a recall and to ensure public safety.

CMS New Regulations Focus on Nursing Facilities Improving Resident Care

The Centers for Medicare and Medicaid Services (CMS) efforts to strengthen the nation’s health care through its oversight of health care programs, including Medicare, has continuously made strides to ensure its beneficiaries receive the quality and affordable health care needed. The U.S. has struggled with the quality of care provided in nursing homes to the most vulnerable citizens for years. Nursing homes have continued to remain highly regulated, but the U.S. government has failed to hold the nursing homes industry accountable for the poor quality of care provided. America’s shortage of nurses has contributed to the poor quality of care that leads to life threatening problems of Medicare beneficiaries living in nursing homes. Furthermore, despite the nursing home industry’s large profitability, and the level of hands on care that the nurses provide, the pay for staff nurses in nursing homes is less than other major employers. Thus, CMS has implemented regulations to guarantee nursing homes are properly staffed in order to improve resident care and safety by monitoring payroll-based data and holding nursing homes accountable for poor care by minimizing reimbursement for conditions that could be averted with better oversight.

OIG Work Plan on Nursing Facility Staffing Levels

In August, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) made an additional focus in its Work Plan for the oversight of nursing facility staffing levels. These changes were made in the light of backlash from a July 2018 news article which reported that nearly 1,400 nursing homes had fewer qualified staff on duty than they were required or failed altogether to provide reliable staffing information to the Centers for Medicare and Medicaid Services (“CMS”).

“Dr. Death” Loses Appeal, Court Upholds Life Sentence

In December 2018, Dr. Christopher Duntsch lost his appeal and the court upheld his life sentence.  The name may not sound familiar, but to the medical community in Dallas, Texas, Christopher Duntsch represents what happens when every part of the medical regulatory system fails to protect patients. Christopher Duntsch was given the nickname “Dr. Death” in November 2016 when the DMagazine ran a cover story on him and his victims. In 2018, Wondery produced a six-part podcast series named “Dr. Death” detailing Duntsch’s educational and medical history and the acts that led him to incarceration.

Facebook’s Watching… For Now

Ever since the Facebook and Cambridge Analytica scandal, concerns surrounding data privacy and protection have been growing. Both government agencies and individual users have particularly been concerned on how their data is being collected and used on social media websites such as Facebook. Germany has taken action in response to such concerns and recently took a step against Facebook’s collection of data in a decision that outlawed Facebook’s entire advertisement regime.