Health Care Archives - Page 5 of 8

FDA Approves Software Application That Alerts Providers of Potential Stroke in Patients

On February 13, 2018 FDA approved a software application with clinical-decision support capability, in this case alerting providers of a potential stroke in patients. The system, “Viz.AI Contact,” is developed by a US/Israeli company named Viz.ai, which uses artificial intelligence and machine deep learning for analyzing medical images. Earlier in January, this system also received a CE Mark from the European authorities.

Stroke is caused by an interrupted blood supply to the brain; for example, due to a blood vessel’s rupture. Stroke is among leading causes of mortality and long-term disability in the U.S. and other countries. The Viz.AI Contact system analyzes brain computed tomography (CT) scans, identifies a suspected large vessel blockage, and sends a text notification to the health care specialist.

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Involuntary Dissolution Does Not Absolve Business Associate of HIPAA Obligations

A receiver appointed to liquidate the assets of Filefax, Inc. has agreed to pay $100,000 to the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) in a no-fault settlement regarding potential violations of the Health Insurance Portability and Accountability Act (HIPAA).

Filefax, an entity involuntarily dissolved by the Illinois Secretary of State in August 2017, previously provided services to HIPAA covered entities, including storage, maintenance, and delivery of medical records. On February 10, 2015, OCR received an anonymous complaint alleging that an individual had transported medical records obtained from Filefax to a shredding and recycling facility to sell on February 6 and 9, 2015. OCR investigated the matter and confirmed that an individual had left medical records that contained the protected health information (PHI) of approximately 2,150 patients at the shredding and recycling facility. OCR’s investigation indicated that Filefax had either left the PHI in an unlocked truck in its parking lot or granted permission to an unauthorized person to remove the PHI from Filefax, and left the PHI unsecured outside of the Filefax facility.

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OCR Kick Starts 2018 with Severe $3.5 Million HIPAA Settlement and Corrective Action Plan

Fresenius Medical Center North America (FMCNA) agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a two-year comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA).

The no-fault resolution agreement states that FMCNA reported five separate incidents that occurred between February 23, 2012 and July 18, 2012 at five distinct FMCNA facilities (FMCNA Covered Entities). FMCNA provides centralized corporate support to the FMCNA Covered Entities, including storing patient’s medical records, creating and disseminating HIPAA policies and procedures, and investigating the circumstances surrounding each breach reported to it by the FMCNA Covered Entities.

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Singapore Addresses Confidentiality of Electronic Patient Records in New Healthcare Services Bill

Singapore’s Ministry of Health (MOH) recently drafted a new Healthcare Services (HCS) Bill aimed to bridge the gap between the country’s changing healthcare needs and technological advances. According to the MOH, the healthcare landscape in Singapore is undergoing significant changes, including an ageing population, increased chronic disease prevalence, and advancements in medicine and health technologies. The HCS Bill will “better safeguard the safety and well-being of patients, while enabling new and innovative services that benefit patients to be developed, in the changing healthcare environment.”

Currently, healthcare providers in Singapore are licensed and regulated under the Private Hospitals and Medical Clinics Act (PHMCA), which was designed to protect patient safety through the licensing of physical healthcare premises. But, brick and mortar locations are quickly becoming a thing of the past as more and more healthcare services are delivered through mobile and online channels. MOH intends to respond to this shift by repealing the PHMCA and replacing it with this new HCS Bill.

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Connecticut Supreme Court Establishes Private Right to Sue Over Medical Record Breaches

The Connecticut Supreme Court has joined several other states by holding that health care providers owe patients a common law duty to maintain the confidentiality of their medical records. In a unanimous reversal of the lower court’s ruling, the court determined that the unauthorized disclosure of confidential information obtained in the course of a physician-patient relationship gives rise to a cause of action in tort against the health care provider, unless the disclosure is otherwise allowed by law.

Emily Byrne sued the Avery Center for Obstetrics and Gynecology, P.C. (“Avery”) for negligence and negligent infliction of emotional distress in connection with Avery’s release of her medical records in response to a subpoena issued by her ex-boyfriend, Andro Mendoza, in the course of a paternity action. The subpoena instructed Avery to send the custodian of its records to appear, together with Byrne’s medical records, at the New Haven Regional Children’s Probate Court. Avery did not alert Bryne about the subpoena, file a motion to quash it, or appear in court – it mailed Byrne’s medical records. Bryne alleges that she suffered harassment and extortion threats from Mendoza because Avery gave him access to her medical records without her knowledge or consent.

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CMS Confirms Policy on Texting Patient Information among Healthcare Providers

The Centers for Medicare & Medicaid Services (CMS) recently issued a State Survey & Certification Memorandum effective immediately in order to clarify its position on texting patient information among health care providers.

Although CMS acknowledges that the use of texting to communicate with other members of a patient’s health care team has become a common and invaluable practice, it acknowledges that such practice risks noncompliance with the Medicare Conditions of Participation (CoPs) or Conditions for Coverage (CfCs). In order to text and comply with the CoPs or CfCs, CMS requires providers to use, maintain, and routinely assess secure, encrypted systems or platforms and minimize the risks to patient privacy and confidentiality per the Health Insurance Portability and Accountability Act and other requirements under the CoPs or CfCs.

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DISCERNING DATA

A Faegre Drinker Blog Covering the Latest in Privacy, Cybersecurity and Data Strategy

Category: Health Care