Yarmela Pavlovic

Firm/Organization: Hogan Lovells

Blogs: Focus on Regulation, Global Media and Communications Watch

Latest Articles

Internet of Things Webinar Series – Health Care and the Internet of Things: New Regulatory Developments

By Trey Hanbury, Yarmela Pavlovic & George John

August 6, 2019

Mobile phone applications are already tracking intimate health data, including our sleep habits, steps walked, body measurements, nutrition, and more. Apps draw this information from the devices many of us now religiously maintain along with our daily wardrobe. In this data-hungry age, doctors and health care providers can apply artificial intelligence (“AI”) to the data to help them provide patients personalized and immediate help. The mobile applications, wearable devices, and artificial intelligence use are here…

Focus on Regulation

Would you like an extra application with that? FDA mulls requiring dual applications for combination products

By Philip Katz, Randy Prebula, Heidi Gertner, Yarmela Pavlovic & Lina Kontos

February 8, 2019

On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market. Although the draft guidance doesn’t break new ground, it provides some useful clarity; for example, it includes detailed illustrations of five circumstances when those pathways apply. Citing existing FDA manuals and guidance documents, the 22-page draft guidance addresses the: definition of combination products under 21 CFR …

Global Media and Communications Watch

Internet of Things Webinar Recording: Medical Devices

By Yarmela Pavlovic, Paul Otto, Elisabethann Wright & Fabien Roy

June 14, 2018

In the third instalment of the 2018 Internet of Things Webinar (IoT) Series, Yarmela Pavlovic, Paul Otto, Elisabethann Wright, and Fabien Roy hosted an educational webinar focusing on the evolving world of connected medical devices. Fabien described the regulatory framework applicable to digital health technologies regulated as medical devices in the EU. He explained the criteria which must be met by products to be considered as medical devices and in particular when a health app…

Focus on Regulation

Obtaining FDA clearance or approval of digital health products

By Yarmela Pavlovic & Susan Lee

March 14, 2018

Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a specific drug or biological product, as combination products requiring clearance or approval from the agency prior to marketing. Regulation of standalone devices The FDA regulates medical devices products, including software applications, that are intended for use in the treatment or diagnosis of individual patients. The agency interprets this definition quite broadly,…

Focus on Regulation

Mobile medical apps are a form of medical device — and are regulated as such

By Yarmela Pavlovic

June 22, 2016

As they grow in popularity and functionality, mobile devices increasingly connect people virtually with the places and institutions they would otherwise visit in person. These include malls, banks, and even their own workplace. More and more, mobile devices are also connecting people with one of the places they least want to go: doctor’s offices. “Medical companies are looking to leverage mobile platforms to help patients communicate with healthcare providers, capture data about their medical condition…

Focus on Regulation

FDA Clarifies Expectations for Use of Electronic Health Records in Clinical Investigations

By Robert Church, Melissa Bianchi, Heidi Gertner, Yarmela Pavlovic & Justin Yu

May 19, 2016

On May 17, 2016, FDA published a Draft Guidance for Industry regarding use of electronic health records (EHRs) in clinical trials, building on previously issued guidance on computerized systems and electronic source data used in clinical investigations. As summarized below, this Draft Guidance provides a number of important recommendations to study sponsors who rely on electronic data that are generated and maintained by healthcare facilities in the routine care of patients. For purposes…

Focus on Regulation

FDA and CMS Make Case Before Congress for FDA Oversight of Laboratory Developed Tests

By Janice Hogan, Jonathan Kahan, Randy Prebula, Yarmela Pavlovic, Susan D. Tiedy-Stevenson & Erkang Ai

February 12, 2016

On November 17, 2015, leaders from both the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) testified before the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health regarding regulation of Laboratory Developed Tests, or LDTs. Read More: FDA and CMS Make Case Before Congress for FDA Oversight of Laboratory Developed Tests…

Focus on Regulation

FDA Offers New Recommendations for Interoperability of Connected Devices

By Yarmela Pavlovic, Jennifer Henderson & Lina Kontos

February 10, 2016

On January 26, 2016, the Food and Drug Administration (FDA or the Agency) released a draft guidance document, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (Draft Guidance). Read More: FDA Offers New Recommendations for Interoperability of Connected Devices…

Focus on Regulation

Congress Suspends Medical Device Tax for Two Years

By Janice Hogan, Jonathan Kahan, Yarmela Pavlovic & John Stanton

February 10, 2016

The tax and spending bill signed into law by President Obama last week included a two year suspension of the medical device excise tax. After years of effort by industry to abolish the tax, proponents of the suspension speculate that it may represent a window to full repeal. Read More: Congress Suspends Medical Device Tax for Two Years…

Focus on Regulation

Hogan Lovells and Dohmen Life Science Services Medical Device Seminar on New Developments Related to Medical Device Regulation

By Jodi Scott, Yarmela Pavlovic, Gerry Prud'homme, John Smith, Randy Prebula & Mike Heyl

February 17, 2015

Hogan Lovells and Dohmen Life Science Services invite you to a seminar on new developments related to medical device regulation. The seminar will take place on February 19, 2015 from 8:30 a.m. to 5:00 p.m. at Hogan Lovells’ Silicon Valley office. Breakfast and lunch will be provided, ending with a cocktail reception. Click here to view the agenda. Register here.…

Yarmela Pavlovic

Internet of Things Webinar Series – Health Care and the Internet of Things: New Regulatory Developments

Would you like an extra application with that? FDA mulls requiring dual applications for combination products

Internet of Things Webinar Recording: Medical Devices

Obtaining FDA clearance or approval of digital health products

Mobile medical apps are a form of medical device — and are regulated as such

FDA Clarifies Expectations for Use of Electronic Health Records in Clinical Investigations

FDA and CMS Make Case Before Congress for FDA Oversight of Laboratory Developed Tests

FDA Offers New Recommendations for Interoperability of Connected Devices

Congress Suspends Medical Device Tax for Two Years

Hogan Lovells and Dohmen Life Science Services Medical Device Seminar on New Developments Related to Medical Device Regulation

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