Publications by Melissa L. Markey

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Remanufacturing or Servicing of Medical Devices: FDA Issues Final Guidance Providing Additional Clarification

[06/21/24]

FDA's Data Monitoring Guidance Reveals Future Expectations

[06/11/2024]

From Discretion to Regulation: What FDA’s Final Rule Means for Laboratory Developed Tests

[06/05/24]

Data Monitoring Committees in Clinical Trials: FDA Draft Guidance Released

[05/22/24]

“Patient Rights: Informed Consent and Clinical Research.” Enterprise Risk Management for Health Care Fourth Edition, AHLA/ASHRM, March 2024.

Preparing for Change: After 20 Years, HHS Proposes Update to Research Misconduct Regulations 

[02/16/24]

A Whole New World for Laboratory Developed Tests – FDA Proposes End to Its Longstanding Policy of Enforcement Discretion

[11/30/23]

Biden Administration Issues Executive Order on Artificial Intelligence with Potential Big Impacts for the Health Care Sector

[11/28/23]

FDA Finalizes Its Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors

[10/05/23]

Embracing Technology: FDA Releases Draft Guidance on Decentralized Clinical Trials

[09/14/23]

A Look Back at the Office of Prescription Drug Promotion Enforcement in 2022 and Lessons for 2023

[03/29/23]

OCR Issues Bulletin Regarding the Use of Web Tracking Technologies

[12/21/22]

Scrutiny Increases into the Use of Website Tracking Tools in Health Care

[08/19/22]

FDA Revises Health System Compounding Guidance, Implementing a More Practical Approach

[10/14/21]

PREP Act Eligibility Expanded for Pharmacists, Pharmacy Technicians and Interns Administering COVID-19 Therapeutics

[10/01/21]

Medicare Payment for COVID-19 Vaccines and Antibody Therapy

[12/21/20]

Important Information for COVID-19 Vaccine Providers

[12/15/20]

Overview of Legal and Practical Considerations for Employers Concerning COVID-19 Vaccination Policies

[12/10/20]

CMS Accepting Waiver Applications to Permit Hospital Care at Home

[11/30/20]

Federal Agencies Warn of Significant and Imminent Cyber Security Threat Targeting the Health Care and Public Health Sectors

[10/29/20]

Potential Vendor Breach

[07/17/20]

PREP Act Immunity for Pharmacists Ordering COVID-19 Tests: New HHS OGC Advisory Opinion Addresses Conflicting State Laws

[05/21/20]

Indiana’s House Enrolled Act No. 1004 – Two Key Developments That Will Affect Every Physician Employer in Indiana (Part II of II)

[05/18/20]

FDA Details Authorized Treatment Pathways and Collection Requirements for Administration of COVID-19 Convalescent Plasma

[04/21/20]

FEMA Restricts Export of PPE in Temporary Final Rule

[04/10/20]

Zooming into Risk During COVID-19

[04/08/20]

Health Care Providers and FEMA’s COVID-19 Public Assistance

[04/03/20]

Seeking Solutions for Scarce Resources: Options to Boost Medical Supplies and Devices to Battle COVID-19

[03/26/20]

FDA Issues Guidance on COVID-19 Disruptions to Clinical Trials

[03/19/20]

Battling the Bugs: Cybersecurity During a Pandemic

[03/19/20]

HIPAA Compliance During the COVID-19 Pandemic

[03/18/20]

USDA Hemp Producer License – Do the Opportunities Outweigh the Risks?

[01/27/20]

Apple Debuts Application for Users to Participate in Health Studies

[11/22/19]

Homeopathic Products Manufacturers Beware – FDA Steps Up Plans for New Enforcement Regime

[10/25/19]

Deficient Risk Analyses, Stolen Records and Disclosure of NFL Player’s PHI Leads to $2.15 Million Penalty

[10/25/19]

What’s in YOUR Cannabidiol Product Claim? FDA and FTC Want to Know

[10/24/19]

Failure to Provide Timely Access to Records Results in $85,000 Fine

[09/10/19]

The Practice of Medicine vs. Protecting Patient Safety: Groundbreaking Court Ruling in Support of the FDA’s Regulation of Certain Stem Cell Therapies

[06/11/19]

Consider Website and Other Technology Accessibility Obligations to Better Serve Your Community and Avoid Litigation and Loss of Federal Funding

[03/01/19]

Digital Medicine: OIG Approves Arrangement to Provide Smartphones to Patients

[02/15/19]

Important Alert: Response to Emailed Bomb Threats

[12/13/18]

Department of Homeland Security and FDA Collaborate to Address Medical Device Cybersecurity

[11/02/18]

Hurricane Florence: HHS Responds to a Public Health Emergency by Issuing HIPAA Privacy Rule Waiver and Equal Access Guidance

[09/19/18]

OIG Requests Information from Stakeholders to Expand Anti-Kickback Statute and Civil Monetary Penalty Safe Harbors

[09/14/18]

Blockchain in Health Care Explained: A Three-Part Series

[07/26/18]

Delay of “2018 Requirements” that Revise the Common Rule

[04/04/18]

SSAE 18 Replaces SSAE 16 Data Security Audit Standard – Practical Takeaways

[01/22/18]

CMS Clarifies that Texting PHI Through Secure Platforms Is Permissible – But Not Orders!

[12/29/17]

Final FDA Guidance on Interoperable Medical Devices

[09/20/17]

HHS Finalizes Major Updates to Regulations for Protection of Human Research Subjects

[01/19/17]

Privacy Shield Principles Permit Transfer of Personal Data Between United States and European Union

[10/04/16]

Your Money or Your PHI: New Guidance on Ransomware

[07/19/16]

Safe Harbor Agreement Between United States and EU Ruled Invalid

[10/06/15]

Ebola Preparedness – Important Takeaways from the October 21, 2014 Livestream Session

[10/22/14]

Ebola Preparedness – Take Steps Now to Ensure Health Care Workers and Hospitals Are Prepared to Care for Ebola Patients

[10/17/14]

Ebola Preparedness – Detect, Protect and Respond: Next Steps for Health Care Providers and In-House Counsel

[10/13/14]

Ebola Preparedness: Considerations for Clients and In-House Counsel

[10/03/14]

Attorney-Client Privilege - Healthcare Compliance Legal Issues Manual, AHLA

HIPAA Confidentiality (ed.) - Healthcare Compliance Legal Issues Manual, AHLA Attorney-Client Privilege - AHLA

HIPAA Security - Healthcare Compliance Legal Issues Manual, AHLA

Privacy Issues - The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech, AHLA

Federal Regulators Accepting Comments on Health IT Regulatory Framework

[04/10/14]

FDA, ONC and FCC Issue Long-Awaited Recommendations for Regulation of Health IT

[04/10/14]

FDASIA Report Tasks FDA with Clarifying Its Approach to Health IT

[04/10/14]

Ebola: A Public Health and Legal Perspective - ABA Health eSource

FDA Proposes Giving Clinical Research Sponsors More Input Prior to IDE Submissions

[10/02/13]

Off-Label Use of Medical Products: Warranty and Indemnification Considerations in Purchase Agreements

[04/11/13]

FTC Issues Mobile Privacy and Security Publications

[02/22/13]

Security Considerations in Technology Contracting - Implementing Information Security in Healthcare: Building a Security Program, HIMSS

HHS to Extend the Comment Period for Proposed Rulemaking on Human Subjects Research Protections

[08/31/11]

NLRB Issues Final Rule Requiring Private Employers to Post Notice of Employee Rights

[08/29/11]

HHS Issues Final Rule Updating Financial Conflict of Interest Rules for Investigators

[08/29/11]

Scientific Misconduct in Research - Journal of Health & Life Sciences Law, AHLA

We Know Where You Are: RFID In Healthcare - ABA Health eSource

Hospital Surge Capacity - AHLA