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COVID-19 Causing a Surge in E-Commerce—Is Your Website Accessible?

Stay-at-home orders and business closures during the Coronavirus (COVID-19) pandemic have led to a sharp increase in online shopping. While e-commerce has helped businesses stay afloat during this challenging economic time, there has also been a spike in litigation alleging that certain websites are not accessible to individuals with disabilities. In an article for Bloomberg Law, Jeremy White, Matthew Cin and Brian Long review the legal landscape governing accessibility of websites – including specific rules that apply to the healthcare industry, and explore best practices for companies to mitigate their risk of facing a website accessibility lawsuit. Click here to read the full article.

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Future Forward: Data Arrangements During and After COVID-19

The need for speedy and more complete access to data is instrumental for healthcare providers, researchers, pharmaceutical, biotech and device companies and public health authorities as they work to quickly identify infection rates, disease trends, outcomes, including antibodies, and opportunities for treatments and vaccines for COVID-19. A variety of data sharing and collaborations have emerged in the wake of this crisis, such as: Requests and mandates by public health authorities, either directly or via providers’ business associates requesting real time information on infections and bed and equipment availability Data sharing collaborations among providers for planning, anticipating and tracking COVID-19 caseloads Data sharing among providers, professional societies and pharmaceutical, biotech and medical device companies in search of testing options, treatment and vaccine solutions, and evaluation of co-morbidities CLICK HERE TO VIEW THE FULL...

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Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents

The 21st Century Cures Act, enacted in December 2016, amended the definition of “medical device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) to exclude five distinct categories of software or digital health products. In response, the US Food and Drug Administration (FDA) issued new digital health guidance and revised several pre-existing medical device guidance documents. FDA also stated that it would continue to assess how to update and revise these guidance documents as its thinking evolved. Late last week, FDA issued five final guidance documents and re-issued a draft guidance document to better reflect FDA’s current thinking on software as a medical device (SaMD) and other digital health products: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – Guidance for Industry and Food and Drug Administration Staff General Wellness: Policy for Low Risk Devices – Guidance for Industry...

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Live Webinar: Developing and Procuring Digital Health AI Solutions: Advice for Developers, Purchasers and Vendors

Join McDermott next Wednesday for a live webinar on the unique considerations in developing and procuring AI solutions for digital health applications from the perspective of various stakeholders. We will discuss the legal issues and strategies surrounding: Research and data mapping essential to the development and validation of AI technologies Protecting and maintaining intellectual property rights in AI solutions Technology development Risk management and mitigation for various contractual arrangements, including contracts with customers, vendors and users We will also focus on the trends in US law for AI solutions in the digital health space, and present actionable advice that will help you develop an effective strategy for developing and procuring AI solutions for digital health applications. Developing and Procuring Digital Health AI Solutions: Advice for Developers, Purchasers and Vendors Wednesday, June 13, 2018 | 11:00 am CT | 12:00 pm ET Register...

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Recycle, Recycle, Recycle: Key Considerations for Research, Medical Education, and Other Secondary Uses of Data

The digitization of health care and the proliferation of electronic medical records is happening rapidly, generating large quantities of data with potential to provide valuable insights into disease and wellness and help solve challenging public health problems. There is tremendous enthusiasm over the possibilities of leveraging this data for secondary use–i.e., a use of data that is distinct from the purpose for which it was originally collected. However, such secondary use is often subject to intersecting legal and regulatory regimes–including HIPAA, the Common Rule, and the Federal Food, Drug, and Cosmetic Act and its implementing regulations–that are not fully harmonized.  This lack of harmonization in requirements, coupled with the wide range of industry players involved–including regulators, academic medical centers, health systems, payers, technology companies, manufacturers and industry entities, research institutions, registries, and professional...

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Surfing “Tech’s Next Big Wave”: Navigating the Legal Challenges in Digital Health

Fortune’s April 2018 cover story, “Tech's Next Big Wave: Big Data Meets Biology,” conveys loudly and clearly that technological innovation is transforming the health care continuum—changing the way care is delivered, as well as how patients manage their ongoing health—and as patient demand for health innovation increases, more companies seem eager to hop on the digital health bandwagon. The article provides a thoughtful, realistic (and somewhat sobering) perspective on digital health innovation’s successes and other results to date. It also quite effectively uses real world stories to convey the human dimension of digital health. One is the story of a mother who manually sampled and recorded her son’s glucose levels 20 times a day before an automated monitoring system connected to a mobile app allowed them both to live their lives without constant interruption by this critical care management function. Another describes use of an artificial intelligence...

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Telehealth and the Changing Regulatory Landscape: Opportunities and Challenges in the Digital Health Ecosystem

What if you didn’t have to take time out of your day to see a physician in person when you needed a prescription? What if a diagnosis could be delivered over video chat? What if your psychiatrist was available at the press of a button or swipe on your screen? These options are fast becoming a reality, as telehealth (or telemedicine) continues to take hold in a health care system that is desperate for increased efficiency and higher quality outcomes. And while telehealth offers exciting new possibilities in terms of convenience and access for patients, it also poses new regulatory challenges for industry stakeholders still learning the new rules of the game in today’s digital health ecosystem. The Chronic Care Act One of the biggest drivers of change in the industry right now is the Chronic Care Act. Last month, as part of the House and Senate budget deal to fund the government through March 23, legislators included the Creating High-Quality Results and...

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Walking the Fine Line between the Delivery of Health Care Services and Information/Educational Support

The explosion in digital health solutions that connect consumers with licensed health care providers (e.g., nurses, nutritionists, physicians) and laypersons who have certain informal training (e.g., wellness guide, lifestyle coach, outreach partner) has the potential to blur the lines between what constitutes the practice of a licensed health care profession and what does not (usually because the service is intended to be merely informational or educational). Why does it matter which side of the line a particular service falls on? If a service is one that is delivered by a licensed health care professional, there are various state laws and regulations that may govern the activity, and different potential causes of action that may apply in the event a consumer/patient is injured in the process. If a digital health solution connects a consumer to an individual who is engaged in an activity that is normally performed by a licensed health care professional,...

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A Declaration without a Response: Senators Urge DEA to Enact Regulations on Opioid-Based Addiction Treatments Using Telemedicine

This past fall, after months of speculation, President Trump declared the opioid crisis sweeping the United States a national public health emergency. Upon the president’s declaration, Acting Health and Human Services Secretary Eric D. Hargan made a formal declaration under Section 319 of the Public Health Service Act, making available an exception to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Haight Act) that would allow providers to prescribe controlled substances using telemedicine without first conducting an in-person visit.  Currently, the Haight Act restricts the ability of a provider to prescribe controlled substances using telemedicine without first conducting an in-person examination, unless an exception applies. For a detailed discussion regarding the Haight Act and the restrictions on the use of telemedicine to prescribe controlled substances within the context of the treatment of opioid addiction and mental health...

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Understanding the Implications of Federal Remote Prescribing Laws on Telemedicine’s Role in Behavioral Health Treatment

The opioid epidemic is making the United States acutely aware of the horrors of substance abuse disorders and the limited means of treating the individuals suffering from addiction. Rural America is among the places hit hardest by opioid addiction while also having limited access to mental and behavioral health providers. Telemedicine offers a viable solution to provider shortages, particularly with an eye toward mental health care professionals. Although telemedicine alone will not remedy the shortage of psychiatrists in the United States, the technology does possess the capability of greatly increasing access to them; however, a large driver of psychiatric care is provided through pharmaceutical treatments. The ability for providers to prescribe pharmaceuticals, particularly controlled substances, to patients the provider has not seen in person is limited by the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Haight Act). The relevance of the...

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