Colin J. Zick

Colin J. Zick

Foley Hoag LLP

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HIPAA Compliant Technology and the Importance of Encryption

We welcome this guest blog by Gene Fry, Compliance Officer, Scrypt, Inc. The Health Insurance Portability and Accountability Act (HIPAA) sets the standard for protecting sensitive patient data. This means that any...more

2/24/2015 - Business Associates Covered Entities Cybersecurity Data Breach Data Protection Electronic Medical Records Electronically Stored Information Encryption HIPAA HITECH PHI

Update on President Obama’s “Summit on Cybersecurity and Consumer Protection,” Part II: The Executive Order

As a follow up to our summary of the key takeaways from the White House’s first Summit on Cybersecurity and Consumer Protection, the centerpiece of which was President Obama’s signing of a new Executive Order, “Promoting...more

2/18/2015 - Barack Obama Cybersecurity Cybersecurity Framework Cybersecurity Summit Executive Orders Information Sharing Private Sector

SEC Office of Compliance Inspections and Examinations Releases Cybersecurity Examination Sweep Summary of Investment Advisers and...

Our colleagues Catherine M. Anderson and Kate Leonard of our Investment Management group have summarized the February 3, 2015 findings by the Office of Compliance Inspections and Examinations (OCIE) of its Cybersecurity...more

2/6/2015 - Broker-Dealer Cybersecurity Investment Adviser OCIE Risk Alert SEC

FDA Issues Draft Guidance on Medical Device Accessories

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.” The draft guidance...more

1/23/2015 - Draft Guidance FDA Medical Devices

Life Sciences Alert FDA Issues Draft Guidance on General Wellness Products

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “General Wellness: Policy for Low Risk Devices.” The draft guidance carves out a category of products, deemed “general...more

1/23/2015 - Draft Guidance FDA FDCA Life Sciences Software Wellness Programs

One More New Year’s Resolution: Change Your Passwords Before Groundhog Day

The SplashData list of worst passwords of 2014 was just published, and it looks very similar to the list in 2013, 2012, 2011, etc...more

1/20/2015

Both Sides Now: Cloud Security and Privacy Enter the Modern Era with ISO 27018

Until recently, many cloud users felt like Joni Mitchell in her classic song, “Both Sides Now.” No matter how you looked at clouds, you never really understood them, how they worked, or what happened inside them. Cloud...more

12/15/2014 - Cloud Computing Cloud-Based Services Data Protection Data Storage Providers

NLRB Disregards Security Concerns in Ruling That Employees Have a Right to Use Employers’ Email Systems for Non-Business Purposes

Our colleages have analyzed a significant NLRB decision in Purple Communications Inc. that, in most circumstances, employees have a right to use employer email systems for non-business purposes during non-working time. This...more

12/15/2014

New Rule Permits CMS to Revoke Medicare Billing Privileges for Providers/Suppliers with “Pattern or Practice” of Denied Claims

On December 5, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a final rule titled “Requirements for Medicare Incentive Reward Program and Provider Enrollment” (“the Rule”). The Rule implemented several...more

12/11/2014 - Billing Claims Processing Systems Clinical Laboratories CMS Final Rules Health Care Providers Health Insurance Healthcare

The FTC Wants to Regulate the Internet of Things, Including Your Car

The FTC recently filed a comment on the National Highway Traffic Safety Administration’s advance notice of proposed rulemaking related to vehicle-to-vehicle communications. The comment left no doubt that the FTC wants to...more

10/28/2014 - Auto Manufacturers Automotive Industry Digital Communications FTC Internet of Things NHTSA Rulemaking Process

FDA Flunks Data Security Exam

Last week, the HHS Office of Inspector General released a damning report on FDA’s data security: “The objective of this review was to determine whether the FDA’s network and external Web applications were vulnerable to...more

10/28/2014 - Cyber Attacks Cybersecurity Data Protection FDA OIG

Data Breach Prevention and Response: Avoiding Potential Pitfalls and Implementing Best Practices to Protect Your Company

In This Presentation: - Overview of data breach landscape - Data breach response ..Technical best practices ..Legal best practices - Data breach prevention ..Technical best practices ..Legal best...more

10/27/2014 - Best Management Practices Data Breach Data Protection Risk Assessment Risk Management

FCC Enters the Data Security Enforcement Field with $10 Million Fine on Telecoms

In a first for the FCC, it announced on October 24 that it intends to fine two telecom companies $10 million for data security violations...more

10/27/2014 - Corporate Fines Data Protection FCC Personally Identifiable Information Telecommunications

Don’t Put Off That New HIPAA Business Associate Agreement: September 23, 2014 Deadline Looms

It’s been a while, but we have another HIPAA deadline just around the corner: September 23, 2014. September 23, 2014 is the date by which all HIPAA business associate agreements need to be in compliance with the...more

8/28/2014 - Business Associates Deadlines HIPAA HIPAA Omnibus Rule

FDA Releases Final Guidance on the Regulation of Mobile Medical Applications

On September 23, 2013, the Food and Drug Administration (FDA) published the final guidance on its regulation of “mobile medical applications (or apps).” The guidance finalizes FDA’s 2011 draft guidance, adding numerous...more

10/1/2013 - FDA FDCA Healthcare Medical Devices Mobile Apps

The Physician Payment Sunshine Act Final Rule A Summary Of Key Provisions

On February 1, 2013, Centers for Medicare and Medicaid Services (CMS) published the long-awaited Physician Payment Sunshine Act (Sunshine Act) Final Rule, implementing Section 1128G of the Social Security Act. The...more

2/8/2013 - Affordable Care Act CMS Drug Manufacturers Medicaid Medical Devices Medical Supplies Medicare Payment Records Physicians Sunshine Act Teaching Hospitals

Key Elements of the New “Omnibus” HIPAA Privacy and Security Regulations

On January 18, 2013, nearly four years after the passage of the HITECH Act and its amendments to HIPAA, and nearly three years after it proposed regulatory amendments, the U.S. Department of Health and Human Services (“HHS”)...more

1/25/2013 - Business Associates Data Breach Data Protection Electronic Medical Records HIPAA HIPAA Omnibus Rule HITECH Patient Privacy Rights PHI

Massachusetts DPH Finalizes Revised “Gift Ban” Regulations: Softens Rules on Meals, Expense Reporting, and Payment of Med Device...

On November 21, 2012, the Public Health Council promulgated final revised regulations relating to the so-called physician gift ban law, Mass. Gen. Laws c. 111N (“Chapter 111N”). Most notably, the revised regulations now...more

11/27/2012 - Medical Devices Physician Gift-Ban Law

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