Many people are taking advantage of technology to monitor their health and vital signs. But should you monitor your heart with a smartphone? Is this technology approved or regulated by the U.S. Food & Drug Administration? Entering the market in increasing numbers are heart-monitoring apps that are intended to be used as medical devices, which – unlike fitness trackers – must be approved by the FDA. Some are designed for home use, while others are for health care providers.

Digital health technology has revolutionized health care, empowering consumers to make better-informed decisions about their health. The U.S. Food & Drug Administration (FDA) is reevaluating its oversight of digital health technology. The FDA seeks to ensure patients’ timely access to high-quality, safe, and effective digital health products.


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In 2015, prompted by outbreaks of antibiotic-resistant infections linked to duodenoscopes, the FDA issued a Safety Communication, indicating that the complex design of duodenoscopes may impede effective reprocessing. From January 2013 through December 2014, the FDA received 75 Medical Device Reports (MDRs) involving approximately 135 patients relating to possible microbial transmission from reprocessed duodenoscopes. Duodenoscopes are used to visualize the duodenum and upper digestive tract, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. Reprocessing involves a detailed, multistep process to clean and disinfect or sterilize the reusable devices.

The FDA reports that more than 500,000 Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures using duodenoscopes are performed in the United States each year. The procedure is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. The complex design of duodenoscopes improves the efficiency and effectiveness of ERCP. However, that design creates challenges for cleaning and disinfection because some parts of the scopes may be difficult to access. Residual body fluids and organic debris may remain in crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.


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The Wisconsin Court of Appeals recently joined courts in Florida, Illinois, New Hampshire, and Washington in finding that caps on noneconomic medical malpractice damages are unconstitutional.

The appeals court found that Wisconsin’s cap on noneconomic medical malpractice damages always reduces noneconomic damages only for the class of the most severely injured victims who have been awarded damages exceeding the cap. Yet, the cap always allows full damages to the less severely injured malpractice victims. The court therefore concluded that the cap denies equal protection to that class of malpractice victims whose noneconomic damages are determined by the factfinder to be in excess of the cap. The court therefore concluded the statutory cap is facially unconstitutional.


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In Pennsylvania, a medical malpractice lawsuit must be filed in the county where the alleged malpractice occurred.

The Superior Court in Pennsylvania recently reversed a trial court decision in a medical malpractice case that transferred venue from Philadelphia County to Berks County, sending the case back to Philadelphia County.

The case involved a premature infant who was being treated in the neonatal intensive care unit in a Berks County hospital. The infant underwent a transthoracic echocardiogram in Berks County, which was interpreted by a pediatric cardiologist working in a hospital in Philadelphia County. The Philadelphia cardiologist wrote a report of her findings, including her diagnosis and treatment plan. The diagnosis of the Philadelphia doctor was pulmonary hypertension requiring immediate treatment or intervention, which was to be forwarded to plaintiff’s treating providers in Berks County.


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Endo Pharmaceutical’s recent decision to halt sales of Opana ER (oxymorphone hydrochloride) quickly followed the U.S. Food and Drug Administration’s (FDA) request that it remove the abuse-linked opioid pain medication from the market. This is the first time the agency sought to remove a currently marketed opioid pain medication from sale due to the public health crisis of opioid abuse.

In 2015, more than 33,000 people died from opioid overdoses, according to the Centers for Disease Control. Almost half of the deaths involved a prescription medication.


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A physician cannot perform a surgery or other medical procedure on a patient without first obtaining the patient’s informed consent. Informed consent means that the patient was advised of the risks, benefits, and alternatives to the procedure and, knowing these, made the decision to undergo the procedure. A physician can be legally liable where he or she fails to obtain a patient’s informed consent before performing a medical procedure.

In a recent medical malpractice action, the Pennsylvania Supreme Court held that a physician’s duty to provide information to a patient sufficient to obtain her informed consent is non-delegable. Thus, conversations between the patient and members of the physician’s staff will not suffice. The duty to obtain a patient’s informed consent for a major medical procedure belongs to the physician, who must inform the patient about the risks, benefits, likelihood of success, and alternatives.


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The Supreme Court of Florida held that the state’s statutory caps on personal injury noneconomic damages in medical negligence actions violate the Equal Protection Clause of the Florida Constitution. The statute, section 766.118, set noneconomic damages caps of $500,000 per claimant in personal injury or wrongful death actions arising from medical negligence. If the negligence

Access to a nurse’s personnel file became a key issue in a recent PA medical malpractice wrongful death and survival action. In Snyder v. DeCesare, the Court of Common Pleas of Lackawanna County considered whether plaintiffs were entitled to disclosure of the personnel file of defendant Heather Shingler, RN. Plaintiffs alleged that their unborn child died in utero due to negligent fetal monitoring by the nurse, who was subsequently terminated from her employment with defendant Moses Taylor Hospital.

Plaintiffs sought a court order to compel production of the nurse’s personnel file, alleging a nexus between her termination of employment and her alleged negligent fetal monitoring. Defendants claimed there was no connection between the two events. Also, Nurse Shingler denied that her termination was related to the facts alleged in this case.


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On March 10, 2017, the Accreditation Council for Graduate Medical Education (ACGME) announced that first-year doctors will be allowed to work 24-hour shifts in hospitals starting July 1, 2017. The cap that has limited shifts to 16 consecutive hours of patient care since 2011 will be lifted. The 80-hours-per-week cap remains in place.

Balancing the logistics of physician training with the safety and needs of patients has been the subject of controversy and debate for decades. According to a recent article in the New England Journal of Medicine, the debate centers on the concern that longer hours mean less sleep and sleep-deprived residents might make errors. However, that is countered by other concerns about shorter work hours resulting in more patient hand-offs that could affect patient care.


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As reported by philly.com, New Jersey Department of Health investigators have released a preliminary report finding that that the Osteo Relief Institute Jersey Shore in Wall Township deviated from multiple infection control guidelines issued by the Centers for Disease Prevention and Control.

The report indicates that the clinic’s disregard of accepted hygiene practices likely