What are the major risks and rewards of artificial intelligence’s healthcare transformation? In this AHLA podcast episode, Alya Sulaiman offers insight into how healthcare organizations should manage AI governance and examines related legislative and regulatory issues.
Employers have questions about the COVID-19 vaccine and how to update their employment policies. In this video, McDermott partners, Chris Braham, Chris Foster and Michelle Strowhiro answer questions about vaccine requirements in the workforce, additional considerations and more.
Several new, highly public developments showcase prominent executives being subjected to significant financial penalties, loss of employment and reputational damage arising from allegations that they bore responsibility for corporate scandals to which they contributed, directly or indirectly.
Even though these developments are unique in their nature and scope, the sheer magnitude of the penalties asserted and the intensity of the media coverage are likely to attract significant attention in the executive community. They’ve been page-one news; people are noticing and boards may be expected to react.
McDermott’s Michael Peregrine authored an article for Forbes in which he discusses how the spotlight on individual accountability is getting a little bit brighter.
Originally published on Forbes, February 2020
Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance pitfalls. In 2018 and in 2019, several digital health companies faced intense scrutiny—not only from regulatory agencies, but also in some cases from their own investors. While the regulatory framework for digital technology in healthcare and life sciences will continue to evolve, digital health enterprises can take key steps now to mitigate risk, ensure compliance and position themselves for success. We offer three tips for tackling risk in digital health.
Over the past several years, the IRS and DOL have significantly increased the number of benefit plans audits conducted each year.
As a result, it is important for plan sponsors to understand the types of issues that often arise in connection with such audits. At the recent PSCA 2019 National Conference, Brian Tiemann explained what plan sponsors should expect if their benefit plan is selected for audited. More specifically, Brian discussed the ways audits are typically triggered and how to respond when a plan is audited. In addition, Brian outlined some of the most common retirement and health and welfare compliance issues identified in plan audits. He also discussed how plan sponsors can prepare for audits and even address potential compliance issues before they occur.
The General Data Protection Regulation (GDPR) was the biggest story of 2018 in the field of global privacy and data protection. The GDPR became enforceable in European Union Member States on May 25, 2018, significantly expanding the territorial reach of EU data protection law and introducing numerous changes that affected the way organizations globally process the personal data of their EU customers, employees and suppliers. These important changes required action by companies and institutions around the world. In almost six months after the GDPR’s effective date, organizations are still working on compliance—and will be for years to come.
Critical provisions
The GDPR applies to organizations inside and outside the EU. Organizations “established” inside the EU, essentially meaning a business or unit located in the EU, must comply with the GDPR if they process personal data in the context of that establishment. The GDPR also applies to organizations outside the EU that offer goods or services to, or monitor the behavior of, individuals located in the EU.
The GDPR uses other terms not familiar to US businesses but which need to be understood. Both “data controllers” and “data processors” have obligations under the GDPR, and data subjects can bring actions directly against either or both of those parties. A data controller is an organization that has control over and determines how and why to process data. A data controller is often, but not always, the organization that has the direct relationship with the data subject (the individual about whom the data pertains). A data processor is an organization that processes personal data on behalf of a data controller, typically a vendor or service provider. The GDPR defines “processing” to mean any operation or set of operations performed on personal data or on sets of personal data, whether or not by automated means (e.g., collection, recording, storage, alteration, use, disclosure and structuring).
The GDPR also broadly defines “personal data” as any information directly or indirectly relating to an identified or identifiable natural person, such as a name, identification number, location data, an online identifier, or one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person. Organizations in the US are used to a narrower definition of personal data, which typically includes information that, if breached, would put an individual at risk of identity theft or fraud and require notice (e.g., Social Security numbers, driver’s license numbers, and financial account, credit and debit card numbers). (more…)
The search by consumers, payers and providers for more efficient, effective and convenient care delivery models has led to an explosion of technological innovation in the health care sector. This explosion has supported the increased use of telemedicine by providers to reach patients who were previously out of reach, and to provide more timely and cost-effective care.
With the use of telemedicine technologies comes a responsibility on the part of providers to educate and inform patients on the benefits, and more importantly, on the risks associated with receiving care via telemedicine. Like any other care setting, compliance with this responsibility serves the dual purpose of providing consumers with the information needed to make an informed decision about their care, but also mitigates the provider’s potential liability exposure from medical malpractice claims.
On April 22, 2015, the U.S. Securities and Exchange Commission (SEC) announced that it had awarded $1.4 million–$1.6 million to a compliance officer-turned-whistleblower who aided the SEC in an enforcement action against the officer’s employer. This marks the second time an employee with an internal audit or compliance function—who does not typically qualify under whistleblower rules—received an award under the SEC’s whistleblower program dictated by the Dodd-Frank Wall Street Reform and Consumer Protection Act.
Tuesday, February 10, 2015
12:30 – 1:30 pm EST
Please join McDermott Will & Emery for a complimentary webinar discussing key issues retirement plan sponsors should take into account when establishing and maintaining internal controls based on the compliance requirements Internal Revenue Service (IRS) and U.S. Department of Labor (DOL) agents review when they conduct retirement plan audits.
Specific topics will include the following:
McDermott Speakers
Nancy S. Gerrie, Partner, McDermott Will & Emery
Jeffrey M. Holdvogt, Partner, McDermott Will & Emery
To register, please click here.
This article provides a list of 2014 and 2015 health and welfare compliance initiatives that require action by employers, including preparation for upcoming fees and penalties under the Affordable Care Act, filing of required forms and distribution of relevant notices.
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