Spring is rapidly approaching which means SXSW 2020 is right around the corner! Husch Blackwell’s healthcare team is most excited about the Health & Medtech track which brings together innovators, entrepreneurs and investors in the healthcare and technology space. Members of the team will be participating in the various sessions and events that are occurring
The weather has cleared and SXSW is well underway! The HBInnovate team has been sharing its experiences via Twitter and blog, keeping everyone up-to-date on the innovations and creative ideas on display.
Hot at SXSW continues to be healthcare products and services that rely upon a phone or tablet. Everyone sees the tremendous potential phones and tablets have in supporting our health and wellness. One of the most common concerns from healthcare startups has been how to do roll-out products and services compliant with The Food and Drug Administration (FDA).
Given the transformations taking place at every level in healthcare, it is no surprise that the 2017 SXSW Interactive Conference has a big spotlight on the industry. One superstar in the spotlight this year is wearables. The accelerator pitches during SXSW include ones for wearables designed to improve prenatal care and early breast cancer detection, and there is even a presentation on brain wearables to detect stress, improve focus, and even to let you play video games with your brain. That’s right, brain wearables that help you focus and let you play video games.
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A little rain can’t stop SXSW. Husch Blackwell attorneys have attended dozens of interesting presentations and met countless innovative minds. We will continue to post live updates on Twitter (@HBhealthcarelaw) and release brief blog posts related to certain presentations throughout the event. With former VP Joe Biden in town to discuss his cancer moonshot today, our focus is precision medicine.
Precision medicine is an innovative approach to medical treatment that takes into account individual differences in people’s genes, environments, and lifestyles. The promise of precision medicine is delivering the right treatments, at the right time, to the right person. The potential of precision medicine is recognized at the highest levels of government. In his 2015 State of the Union address, former President Barack Obama launched the Precision Medicine Initiative (“PMI”), a bold new research effort to revolutionize health and the treatment of disease. Subsequently, Sylvia M. Burwell, Secretary of the U.S. Department of Health & Human Services (“DHHS”), announced the FY 2016 budget would include $215 million for the PMI, with $200 million of this to be used by the National Institutes of Health (“NIH”) to launch the All of Us program, a national cohort of a million or more Americans who volunteer to share genetic, clinical, and other data to improve research. The funds will also be used to invest in expanding current cancer genomics research and to initiate new studies on how a tumor’s DNA can inform prognosis and treatment choices.
An entrepreneurial company may face an early decision as to how it can afford to develop new technology, particularly new technology that does not fit within the technical specialties of that entity. Whether a new company needs to develop a new website, new software, or a compatible piece of technology, that company might consider entering into a contractual alliance with another party to develop that technology.
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The Telephone Consumer Protection Act (TCPA), which imposes a penalty of $500-$1,500 per violation for pre-recorded or auto-dialed calls to cell phones, contains two statutory exceptions to liability:
47 U.S.C. § 227 (b)(1). While much attention has been focused on “consent,” the FCC’s definition of “emergency purpose” has remained relatively untested in TCPA litigation.
That landscape may be beginning to change. The federal district court’s recent decision in the putative class action lawsuit Roberts v. Medco Health Solutions, et al., No. 4:15 CV 1368 CDP (E.D. Mo., July 26, 2016) recognized that consistent with the FCC’s promulgated definition, the emergency purpose exception must be interpreted broadly to cover any calls that may affect the health and safety of a consumer.
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3D printing continues to transform the medical field. Recently, doctors in Spain produced the world’s first 3D-printed rib cage and sternum, which is made entirely of titanium. The doctors surgically implanted the metal rib cage and sternum in a cancer patient. Last month, the FDA approved the first 3D-printed drug. The drug, which Aprecia Pharmaceuticals has named Spritam, is for treating patients with epilepsy. Aprecia Pharmaceuticals’ ZipDose® Technology utilizes 3D printing that overlays multiple layers of powdered medication on top of one another until the correct dosage is reached. This type of technology can lead to easier-to-take medication that is individualized in nature with precise dosages based on a patient’s needs.
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In an Aug. 27, 2015, decision, a majority of the Board found that the Purple Communications standard, with respect to an employer’s email system, would apply without exception to healthcare providers and, in particular, for acute care hospitals. Contrary to the cogent arguments put forth by member Johnson in his dissent, the majority found there should be no exception to the presumption set forth under Purple Communications that employees have a statutory right to use an employer’s email system for Section 7 related communications during non-working time. The majority also found that the hospital failed to show “special circumstances” to rebut this presumption, notwithstanding the fact that evidence was submitted of studies finding a correlation between employee distractions and patients’ safety and identifying computers and other electronic communication devices as sources of such distraction.
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The Texas Medical Board (TMB) Telemedicine Committee met on Thursday, August 27, 2015. During the meeting they discussed potential changes to the on-call services telemedicine rule (174.11). At the end of the meeting, they instructed board staff to draft proposed revisions to the rule to allow for changes to the rule.
Although the direction to staff was verbal, they focused on several items: expanding the scope of on-call physician specialties a physician can choose from for their on-call services; a diminishing of the current requirement that the on-call physician provide reciprocal services to the original physician; and there also appeared to be consensus that the rule should include a provision which requires the original physician to have responsibility for the on-call care.
It’s a dangerous world for protected information, with major breaches in the news and a challenging cyber-threat environment behind the scenes. The healthcare industry is a prime target, especially given the premium value of health information on the black market. And healthcare entities face not only PHI breach exposures, but also security risks for other forms of protected information, such as PII and, for many, cardholder data.
Healthcare organizations must be prepared to respond to data breaches, but effective response is no small matter. There are 10 different channels of response activity for an organization that has suffered a security breach: Security, Legal, Forensic, Law Enforcement, Regulators, Insurance Coverage, Public Relations, Stakeholders, Notification, and Personnel Management. Most of these activities are involved in every breach, and all must be dealt with in significant breaches. These activities are not sequential. They play out in parallel, with interrelated effects… and with the response clock ticking.
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