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FDA Issues Draft Guidance for Clinical Evaluation of Software As A Medical Device | Digital Health Download
http://www.digitalhealthdownload.com/2016/11/fda-issues-draft-guidance-clinical-evaluation-software-medical-device
Raquo; FDA Issues Draft Guidance for Clinical Evaluation of Software As A Medical Device. FDA Issues Draft Guidance for Clinical Evaluation of Software As A Medical Device. November 22, 2016. Posted in FDA and Healthcare. Last month, the US Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) issued a Draft Guidance for industry entitled Software as a Medical Device (SaMD): Clinical Evaluation. The Draft Guidance relies on IMDRF concepts and definitions to define SaMD, ou...
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New European MEDDEV Guidance on Stand-Alone Software | Digital Health Download
http://www.digitalhealthdownload.com/2016/07/new-european-meddev-guidance-on-stand-alone-software
Raquo; New European MEDDEV Guidance on Stand-Alone Software. New European MEDDEV Guidance on Stand-Alone Software. July 28, 2016. Posted in EU Regulatory and Litigation. On 15 July 2016, the European Commission published a new version. Classification of software has been controversial and subject to interpretation by the regulatory authorities. As discussed in our advisory. The Commission is currently preparing guidelines on mobile health apps that are not. What’s the deal with Watson? Launch of EURO-CAS...
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Time for a Reboot? FDA Issues Draft Guidance on When to Submit a 510(k) for a Software Change to an Existing Device | Digital Health Download
http://www.digitalhealthdownload.com/2016/09/time-for-a-reboot-fda-issues-draft-guidance-on-when-to-submit-a-510k-for-a-software-change-to-an-exi
Raquo; Time for a Reboot? FDA Issues Draft Guidance on When to Submit a 510(k) for a Software Change to an Existing Device. Time for a Reboot? FDA Issues Draft Guidance on When to Submit a 510(k) for a Software Change to an Existing Device. September 9, 2016. Posted in FDA and Healthcare. Comments on the Draft Guidance are due to CDRH by November 7, 2016 ( Docket No. FDA-2011-D-0453. In addition, CDRH held a webinar on August 25, 2016. To discuss the Draft Guidance. For purposes of the Draft Guidance, FD...
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Will FDA Incorporate mHealth into Clinical Trials? | Digital Health Download
http://www.digitalhealthdownload.com/2015/11/will-fda-incorporate-mhealth-into-clinical-trials
Raquo; Will FDA Incorporate mHealth into Clinical Trials? Will FDA Incorporate mHealth into Clinical Trials? November 23, 2015. Posted in FDA and Healthcare. On October 29, 2015, FDA published a Federal Register notice. To establish a public docket to solicit input from a broad group of stakeholders on the scope and direction of the use of technologies and innovative methods in the conduct of clinical investigations. Specifically, FDA is seeking information to understand individual and industry exper...
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Second Draft of the EU mHealth Guidance: “Better Use of Better Apps for Better Healthcare” | Digital Health Download
http://www.digitalhealthdownload.com/2016/06/second-draft-of-the-eu-mhealth-guidance-better-use-of-better-apps-for-better-healthcare
Raquo; Second Draft of the EU mHealth Guidance: Better Use of Better Apps for Better Healthcare. Second Draft of the EU mHealth Guidance: Better Use of Better Apps for Better Healthcare. June 23, 2016. Posted in EU Regulatory and Litigation. At the eHealth Week conference last week, the European Commission presented the latest draft of the EU guidelines. On the assessment of mHealth apps. As set out in our previous post. The draft clarifies that medical devices are not covered by the guidance, and that a...
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FDA Unveils New Website for Anonymous Reporting of Regulatory Violations | Digital Health Download
http://www.digitalhealthdownload.com/2016/12/fda-unveils-new-website-anonymous-reporting-regulatory-violations
Raquo; FDA Unveils New Website for Anonymous Reporting of Regulatory Violations. FDA Unveils New Website for Anonymous Reporting of Regulatory Violations. By SAID SABA JR. December 2, 2016. Posted in FDA and Healthcare. The Food and Drug Administration (FDA) recently introduced a new webpage. Non-FDA-approved promotion or advertising;. Failing to submit required safety reports;. Failing to comply with design or manufacturing responsibilities;. Marketing a device without proper FDA clearance;. US Antitrus...
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OCR Warns of Phishing Scheme Targeting HIPAA Covered Entities & Business Associates | Digital Health Download
http://www.digitalhealthdownload.com/2016/11/ocr-warns-phishing-scheme-targeting-hipaa-covered-entities-business-associates
Raquo; OCR Warns of Phishing Scheme Targeting HIPAA Covered Entities and Business Associates. OCR Warns of Phishing Scheme Targeting HIPAA Covered Entities and Business Associates. By NANCY L. PERKINS. November 30, 2016. Posted in Privacy and Cybersecurity. On November 28, 2016, the US Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued a rare alert. What the scheme is:. What to watch out for:. What to do now:. Inform your employees to be on the lookout for the OCR Phishin...
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About Healthcare Law | Arnold & Porter, LLP
http://www.digitalhealthdownload.com/about
Your Regular Dose of Digital Health Industry News. EU Regulatory and Litigation. With roots in the days of the New Deal and an outstanding record of commitment, excellence, and innovation, Arnold & Porter Kaye Scholer LLP stands today as a preeminent international law firm. Arnold & Porter Kaye Scholer attorneys, practicing in more than 30 distinct areas of the law, conduct business worldwide.
digitalhealthdownload.com
FDA and Healthcare | Digital Health Download
http://www.digitalhealthdownload.com/fda-and-healthcare
Subscribe to FDA and Healthcare. What’s the deal with Watson? Artificial Intelligence Systems and Medical Software Regulation in the U.S. and EU. VICTORIA M. WALLACE. February 24, 2017. Posted in EU Regulatory and Litigation. Some of the ways in which life sciences companies are exploring the potential of IBM’s supercomputer, ‘Watson. How is software regulated? The main benefit of IBM’s cognitive computing software is its ability to analyse large amounts of data to develop knowledge about a disease or co...
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Federal Trade Commission | Digital Health Download
http://www.digitalhealthdownload.com/federal-trade-commission
Subscribe to Federal Trade Commission. FTC Report Highlights Privacy Concerns Associated with Cross-Device Tracking. By NANCY L. PERKINS. January 27, 2017. Posted in Federal Trade Commission. On January 23, 2017, the FTC released a long-awaited report. Regarding the increased incidence of cross-device tracking. The report, which follows a November 2015 FTC workshop. Findings and Recommendations of the FTC Report. The FTC report acknowledges that cross-device tracking can produce benefits for both busines...
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