In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software applications and other transformative technologies, such
Of Digital Interest
Legal news and analysis of all things digital
Of Digital Interest, published by McDermott Will & Emery, focuses on legal developments and issues related to data privacy, cybersecurity, and digital regulation. The blog covers topics such as compliance with the California Consumer Privacy Act (CCPA) and its enforcement, litigation trends involving privacy rights, and proposed legislative changes like the California Privacy Rights Act. It also addresses emerging concerns around technologies such as facial recognition systems, including their legal, ethical, and accuracy challenges. The blog provides insights into how evolving digital laws impact businesses, particularly in areas like data security, consumer rights, and regulatory enforcement.
Latest from Of Digital Interest - Page 5
Vetting Relationships for Telemedicine Collaborations
As the telemedicine regulatory and reimbursement environment becomes more cohesive and providers and patients alike embrace technology, opportunities for telemedicine collaborations are likely to grow. Like any collaboration, finding the right partner is crucial for success, particularly at the…
Telemedicine Collaborations and Partnerships: Key Considerations for Success
Telemedicine collaborations, whether between technology companies and providers, health systems and patients, or other creative partnerships we have yet to see in the industry, can present numerous benefits to our healthcare delivery system and patient outcomes. However, such collaborations present…
Reviewing Key Principles from FDA’s Artificial Intelligence White Paper
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,” announcing steps to consider a new regulatory framework to promote…
DOJ Continues Telemedicine Enforcement in Q2 2019
During the second quarter of 2019, DOJ continued its focus on enforcement activity in telemedicine. As reported in prior editions of the Quarterly Roundup, telemedicine is an expanding field, causing DOJ to pay particular attention to the industry.
In…
FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers
As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of certain medical devices that provide…
Dash to Digital Health? How the Regulatory Sprint to Coordinated Care Could Expand Access to Care
Certain long-standing laws, such as the civil monetary penalty provision prohibiting patient inducements, have hampered providers’ ability to fully leverage remote patient monitoring and other telehealth tools. Many stakeholders are hoping that developments in the Regulatory Sprint to Coordinated Care…
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,…
Digital Health in the UK: The New Regulatory Environment Under the Medical Device Regulation
By Sharon Lamb & Gary Howes
Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years. In the United Kingdom, the excitement and interest in this space has been supported by NHS policies, including proposals in the NHS Long
…
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…