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Though CCPA is Now Live, Questions About Its Constitutionality Linger

As businesses have scrambled to obtain compliance with the California Consumer Privacy Act (CCPA) in recent months, questions surrounding its constitutionality have arisen. As a broad, sometimes unclear state law that imposes significant obligations on businesses around the country, CCPA may be ripe for legal challenge. The strongest bases for such challenges appear to be: (1) that CCPA violates the “Dormant Commerce Clause”; and (2) that CCPA is impermissibly vague. Dormant Commerce Clause The burden that CCPA imposes on out-of-state economic activity may place it in violation of the Dormant Commerce Clause, a legal doctrine created out of the Commerce Clause of the US Constitution. The Commerce Clause allows the US Congress to regulate interstate commerce; from this grant of power, courts have inferred a limitation on the authority of states to regulate interstate commerce, a doctrine coined the Dormant Commerce Clause. On this basis, courts will strike...

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Little by Little, Attorney General Becerra Sheds Light on the CCPA in 2020

Minimal Changes Expected to the Final Regulations On October 10, 2019, the Attorney General issued his Proposed Text of Regulations, along with a Notice of Proposed Rulemaking Action and Initial Statement of Reasons. According to the Attorney General, the regulations will “benefit the welfare of California residents because they will facilitate the implementation of many components of the CCPA” and “provid[e] clear direction to businesses on how to inform consumers of their rights and how to handle their requests.” See Notice of Proposed Rulemaking, page 10. The deadline to submit public comments on the proposed regulations was December 6, 2019. The Office of the Attorney General (OAG) reported receiving about 1,700 pages of written comments from almost 200 parties. Despite this, the Attorney General stated in a news briefing that he does not expect the final regulations to include significant changes. The proposed regulations should give everyone a sense of...

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Three Tips for Tackling Risk in Digital Health

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 in some cases from their own investors. While the regulatory framework for digital technology in health care 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. Be accurate about quality. Ensuring that you have a high-quality product or service is only the first step; you should also be exactingly accurate in the way that you speak about your product’s quality or efficacy. Even if a product or service does not require US Food and Drug Administration clearance for making claims, you still may face substantial regulatory risk and liability if the...

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CMS Innovation Center Proposes Telehealth Solutions in ET3 Model

As part of its efforts to provide patient-centered care and reduce costs for Medicare beneficiaries, the Centers for Medicare and Medicaid (CMS) have developed an Innovation Center model for ambulance care teams: Emergency Triage, Treat, and Transport (ET3). As part of this model, the agency has proposed two potential telehealth offerings: 1) An individual who calls 911 may be connected to a dispatch system that has incorporated a medical triage line to be screened for eligibility for medical triage services prior to ambulance initiation, and 2) telehealth assistance via audiovisual communications technologies with a qualified provider once the ambulance arrives. Key participants in the ET3 model will be Medicare-enrolled ambulance service suppliers and hospital-owned ambulance providers. In addition, to advance regional alignment, local governments, their designees or other entities that operate or have authority over one or more 911 dispatches in geographic...

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GDPR 6 Months After Implementation: Where are We Now?

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...

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