Archives: Health Data

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Pharmaceutical Digital Health Innovators Take Note: FDA Public Hearing on an Innovative Approach to Devices Referencing Drugs

On November 16, 2017, the Food and Drug Administration (“FDA” or the “Agency”) will hold a public hearing on a proposed approach for sponsors seeking to market devices referencing drugs (“DRDs”) when the drug sponsor does not wish to collaborate with the sponsor of the device. FDA will accept comments to the docket until January … Continue Reading

Three Questions You Need to Ask When Negotiating Digital Health Deals

According to a distinguished panel of lawyers from MSD and Covington & Burling, companies involved in Digital Health deals need to ask themselves the following questions: What data is required to develop and deliver the Digital Health solution, and does your company have sufficient expertise in-house to analyze the data? What happens if your technology … Continue Reading

Top Tips and Traps for Cyber Insurance Buyers

Although the National Cybersecurity Awareness Month of October has come to a close, it is not too late for corporate counsel and risk managers to be thinking about cyber-risk insurance — an increasingly essential tool in the enterprise risk management toolkit. But a prospective policyholder purchasing cyber insurance for the first time may be hard … Continue Reading

CHMP Adopts Guideline on Genomic Sampling and Management of Genomic Data

On 14 September 2017, the Committee for Human Medicinal Products (“CHMP”) of the European Medicines Agency adopted ICH Guideline E18 (the “Guideline”) on genomic sampling and the management of genomic data.  The Guideline takes effect on 28 February 2018. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) … Continue Reading

The UK’s Life Sciences Industrial Strategy: Digital Health Implications

On August 30, the UK government published a report by Professor Sir John Bell of Oxford University providing a number of recommendations to government to ensure the long term success of the life sciences sector in the UK (Life Sciences Industry Strategy).  This blog post summarises the key recommendations and observations made from a digital … Continue Reading

Digital Health Checkup: Key Questions Market Players Should Be Asking (Part One)

In the first of a three-part series, Covington’s global cross-practice Digital Health team answers key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Regulatory Questions About Digital Health Solutions 1. What are … Continue Reading

Bar to Data Breach Litigation May Be Dropping; Implications for Digital Health Technologies

At the beginning of August, the D.C. Circuit found that the fact that a data breach has occurred and individual consumer information has been lost may constitute sufficient injury to confer standing on those individual victims at the pleading stage–irrespective of whether any stolen information has been misused. Specifically, Attias, et al. v. CareFirst, Inc., … Continue Reading

FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan

On July 27, FDA published its Digital Health Innovation Action Plan. The plan provides details and timelines for the agency’s Digital Health Innovation Plan, announced by FDA Commissioner Scott Gottlieb last month. The action plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes … Continue Reading

Europe Consults on Digital Health

Digital health solution providers, and users of digital health services, should take note of three recently launched EU public consultations in the digital health space, and may wish to make submissions to help shape the future of digital health initiatives in the EU.  The earliest deadline for submissions is 16 August 2017. EU Commission Transformation … Continue Reading

ICO Rules UK Hospital-DeepMind Trial Failed to Comply with UK Data Protection Law

The UK Information Commissioner’s Office (“ICO”), which enforces data protection legislation in the UK, has ruled that the NHS Royal Free Foundation Trust (“Royal Free”), which manages a London hospital, failed to comply with the UK Data Protection Act 1998 in providing 1.6 million patient records to Google DeepMind (“DeepMind”), requiring the Royal Free to sign an … Continue Reading

European Cloud in Health Advisory Council Calls For Review of eHealth Rules and Ethics of Medical Data Re-Use

On May 11, 2017, the European Cloud in Health Advisory Council (ECHAC) – a group of healthcare organizations, technology companies and patient representatives  –  launched its second whitepaper focused on use of data to improve health outcomes and delivery of care. ECHAC launched the whitepaper at an eHealth Week 2017 session attended by ECHAC participants and … Continue Reading

Twenty-First Century Cures Act Includes HIPAA Provisions

On December 13, 2016, President Obama signed the 21st Century Cures Act (“Cures Act”), Pub. L. 114-255, which aims to expand medical research and expedite the approvals of drug therapies for patients.  The Cures Act also contains several provisions related to the HIPAA Privacy and Security Rules.  None of these provisions make substantive changes to … Continue Reading

Incoming HHS Secretary Tom Price Brings Physician-Focused Perspective to Health IT

Tom Price, the Republican representative from Georgia, has been tapped by President-elect Trump as the new Secretary for the Department of Health and Human Services (HHS). Rep. Price is himself an orthopedic surgeon and comes from a family of doctors and, as a result, is focused closely on the ways in which government regulations burden … Continue Reading

HHS Issues Guidance on HIPAA and Cloud Providers

The Department of Health and Human Services (HHS) recently published guidance on HIPAA requirements governing the use of cloud computing entities, specifically cloud services providers (CSPs). In this guidance, HHS explains that CSPs that create, receive, maintain, or transmit protected health information (PHI) on behalf of a covered entity or business associate are considered business … Continue Reading

GAO Recommends that HHS Strengthen Privacy and Security Guidance and Oversight

Earlier this week the Government Accountability Office released a report critiquing the U.S. Department of Health and Humana Services’ (HHS) oversight of and guidance related to health information security and privacy. (The report is available here.) GAO cited the increasing incidence of hacking and other breaches, which affected over 113 million health records in 2015, … Continue Reading

JAMA Study Finds Low Rate of Digital Health Technology Use Among Seniors

A research letter published this month in the Journal of the American Medical Association reported that only a small fraction of seniors in the United States use digital health technology. The authors applied statistical analysis to data gleaned from a nationally representative sample of Medicare beneficiaries age 65 and older. In 2011, 16% of seniors … Continue Reading

UK Government Considering New Patient Data Security and Research Consent Standards, Sanctions

The UK Government has opened a consultation, running until September 7, 2016, regarding how UK National Health Service (NHS) patient data should be safeguarded, and how it could be used for purposes other than direct care (e.g. scientific research). The consultation comes after two parallel-track reviews of information governance and data security arrangements in the … Continue Reading

ONC Report to Congress Identifies Gaps in Oversight of Privacy and Security of mHealth Technologies and Health Social Media

Earlier this month the U.S. Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC), released a report to Congress highlighting “large gaps” in policies and oversight surrounding access to and security and privacy of health information held by certain “mHealth technologies” and “health social media.” mHealth technologies … Continue Reading

Significant HIPAA Fine Follows Business Associate’s Stolen iPhone

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) recently announced a significant settlement with Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS), a business associate under HIPAA, arising from a breach of protected health information (PHI) after the theft of an employee’s iPhone.  The iPhone … Continue Reading

CMS Issues Guidance Encouraging the Use of Commercial Off-the-Shelf Technology and Software-as-a-Service for Medicaid Eligibility and Enrollment Systems

In March, CMS issued a State Medicaid Directors Letter (SMDL) about the availability of enhanced federal funding for state Medicaid programs’ eligibility and enrollment (E&E) systems. This SMDL represents CMS’s most recent effort to encourage States to use commercial “off-the-shelf” technology and “software as a service,” instead of customized electronic systems developed and built specifically … Continue Reading

FTC Releases Online Tool to Help Health App Developers Identify Applicable Laws

On April 5, the Federal Trade Commission (FTC), in conjunction with the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), released a new web-based interactive tool to assist mobile health app developers in navigating applicable federal laws and regulations in the areas of advertising and marketing, medical devices, and … Continue Reading

HHS Proposes Rule to Increase ONC Review and Oversight of Certified Health IT

The U.S. Department of Health and Human Services and the Office of the National Coordinator for Health Information Technology (ONC) recently proposed a rule to enhance ONC oversight and accreditation of health IT.  Under the rule, the ONC’s primary goal would be to work with health IT developers to remedy any non-conformities with certified health … Continue Reading

Senate HELP Committee Marks Up Precision Medicine, Other “Cures” Bills

Yesterday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a final mark-up of legislation comprising the Committee’s counterpart to the House-passed 21st Century Cures Act.  The HELP Committee approved five bills including S. 2713 to advance the development of “precision medicine” through research and data sharing.  We have reported on the President’s precision medicine … Continue Reading

CMS Expands Scope of Enhanced Match for Promotion of Health IT

On February 29, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a State Medicaid Directors Letter (SMDL) that expands the scope of expenditures eligible for the 90 percent federal match for activities to promote the use of a health information exchange (HIE) and the adoption of certified electronic health record (EHR) technology by … Continue Reading
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